2014 - RS - YING -XIN GU - Esthetic Outcome and Alterations of Soft Tissue Around Single Implant

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    Ying-Xin Gu*Jun-Yu Shi*Long-Fei ZhuangShi-Chong Qiao

    You-You XuHong-Chang Lai

    Esthetic outcome and alterations ofsoft tissue around single implantcrowns: a 2-year prospective study

    Authors’ affiliations:Ying-Xin Gu, Jun-Yu Shi, Long-Fei Zhuang,Shi-Chong Qiao, You-You Xu, Hong-Chang Lai,

    Department of Oral and Maxillo-facialImplantology, Shanghai Key Laboratory ofStomatology, Shanghai Ninth People’s Hospital,School of Medicine, Shanghai Jiaotong University,Shanghai, China

    Corresponding author:Hong-Chang Lai

    Department of Oral and Maxillo-facialImplantology Shanghai Ninth People’s Hospital,School of Medicine Shanghai Jiaotong University639 Zhizaoju Road, Shanghai, 200011, ChinaTel.: +86 21 23271699Fax: +86 21 53073068e-mail: [email protected]

    Key words:   dental implants, pink esthetic score/white esthetic score, soft tissue esthetic out-

    come, tissue level

    Abstract

    Objective:   The aim of this prospective study was to assess the esthetic outcome and alterations of

    peri-implant soft tissue using tissue-level implants. Furthermore, the influencing factors, including

    grafting and gingival biotype, of esthetic outcome of peri-implant soft tissue were also evaluated.

    Materials and methods:   Of 38 patients with single missing anterior tooth in maxilla were treated

    with a Straumann   Standard Plus SLA implant. Bone augmentation was performed in 24 patients.

    Follow-up was conducted at 12 and 24 months after definitive crowns placement. Esthetic outcome

    using the pink esthetic score/white esthetic score (PES/WES) and clinical parameters were evaluated.

    Results:   The mean PES/WES value at baseline, 1-year, and 2-year examination was 13.79, 14.87,

    and 14.96. Significant improvement was found between baseline and 1-year examination

    (P  <  0.01). And the improvement between 1-year and 2-year examination was not significant

    (P  =  0.40). The mean PES changing value in patients with thick biotype was significantly higher

    than those with thin biotype at 2-year after definitive crowns placement ( P  =  0.03). Graft

    procedure had an unfavorable effect on mean PES value both at baseline and at follow-up

    (P  <  0.01). No implants were lost at 2-year examination. Three patients experienced peri-implant

    infection. No significant difference was found with the passage of time in modified plaque index

    (mPI), probing pocket depth (PPD), and modified bleeding index (mBI).

    Conclusion:   According to the present prospective clinical study, it can be concluded that it is

    feasible to use tissue-level implant to support single crowns in esthetic area. Favorable short-term

    esthetic outcome and stability of soft tissue around single implant crowns can be expected in

    patients with or without graft. However, graft procedures might have an unfavorable effect on

    the esthetic outcome. Gingival biotype can be considered as prognostic factor for esthetic

    outcome. RCTs with long-term follow-up are needed to provide evidence for the long-term

    stability of peri-implant soft tissue using tissue-level implant systems.

    In recent years, rehabilitation of single-tooth

    gaps by means of dental implants has become

    a routine treatment with high survival and

    success rates (Pjetursson et al. 2007, 2012;

    Jung et al. 2008). However, the success of

    implant treatment should not be limited to

    achieving osseointegration. The esthetic

    outcome of the reconstruction also becomes

    an important parameter for clinical success

    especially for esthetically sensitive cases.

    For clinical esthetic assessment, both

    implant crown features and peri-implant soft

    tissue stability should be taken into consider-

    ation (Chang et al. 1999). However, peri-

    implant soft tissue meets most clinical chal-

    lenges from the esthetic aspect. The most

    common reasons for esthetic failure

    include disharmonious mucosal color or tex-

    ture, complete or incomplete loss of inter-

    proximal papillae, and recession of soft tissue

    level. So the soft tissue esthetic outcome is

    of paramount importance to achieving clini-

    cal esthetic success (Belser et al. 2004).

    Pink esthetic score (PES) (Furhauser et al

    2005) or pink esthetic score/white esthetic

    score (PES/WES) (Belser et al. 2009) is now

    adopted by more and more studies to assess

    esthetic outcome and alterations of peri-

    implant soft tissue. Connective tissue graft

    might be necessary in about one-third of the

    patients following type 1 (immediate after

    tooth extraction) implants placement to

    *These authors contributed equally to this work.

    The authors claim that none of the material in the articlehas been published or is under consideration for publica-tion elsewhere.

    Date:Accepted 21 March 2014

    To cite this article:Gu Y-X, Shi J-Y, Zhuang L-F, Qiao S-C, Xu Y-Y, Lai H-C.Esthetic outcome and alterations of soft tissue around singleimplant crowns: a 2-year prospective study.Clin. Oral Impl. Res. 00, 2014, 1–6

    doi: 10.1111/clr.12408

    ©  2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd   1

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    achieve steady improvement in PES score (Co-

    syn et al. 2013). Following type 2 (4 – 8 weeks

    after tooth extraction) and type 3 (12 – 

    16 weeks after tooth extraction) implants

    placement, spontaneous improvements of

    PES score might occur in the short-term fol-

    low-up, and then the PES score will likely

    reverse to the baseline level when the obser-

    vational time was prolonged to at least

    3 years after crown installation (Buser et al.

    2011, 2013; Weinlander et al. 2011; Pieri

    et al. 2013).

    It is worth mentioning that only bone-level

    implant systems were used in the above stud-

    ies. Bone-level implant systems were widely

    used in patients needed implant treatment in

    esthetic area because of more concise surgi-

    cal procedures and less bone resportion espe-

    cially when platform-switching technology

    was used (Al-Nsour et al. 2012; Annibali

    et al. 2012).

    Meanwhile, tissue-level implant systems

    are also widely used in clinical practices, and

    few studies have reported the esthetic evalua-

    tion using tissue-level implant systems. A

    previously published study by our group has

    proved that tissue-level implant systems can

    also achieve predictable soft tissue appear-

    ance on the premise of accurate implant

    placement depth (Lai et al. 2008). How-

    ever, the follow-up was relatively short

    (6 – 8 months), and patients in need of graft

    procedures were excluded. To our knowledge,

    this is the first prospective study reporting

    the PES index of soft tissue using tissue-level

    implants in patients with and without bone

    augmentation.

    Therefore, the aims of the present study

    were (i) to assess the esthetic outcome and

    alterations of peri-implant soft tissue using

    tissue-level implants after 2-year follow-up

    and (ii) to study the influencing factors,

    including grafting and gingival biotype, of

    esthetic outcome of peri-implant soft tissue.

    Material and methods

    Study design and patient data

    This study was design as a prospective study

    with 2-year follow-up. The study was

    conducted at the Department of Oral and

    Maxillofacial Implant of the Shanghai Ninth

    People Hospital. From May 2010 to May

    2012, 40 generally healthy patients (18

    women and 22 men), aged from 19 to

    58 years (mean 31.3 years), were included in

    this study. All patients signed the informa-

    tion consent from and received oral hygiene

    instructions before the implant surgery was

    performed. Fig. 1 shows the flow of clinical

    procedures. The inclusion criteria were as fol-

    lows:

    1. Patients in need of single-tooth restora-

    tion in the anterior maxilla;

    2. Tooth extraction at least three months

    before implant surgery;

    3. No severe vertical bone defect and

    enough primary stability to achieve

    simultaneous implant placement;

    4. Not be heavy smokers (>10 cigarettes/

    day);

    5. Not require restorative treatment of the

    adjacent teeth.

    Intervention

    Implant placement

    All the implants used in this study were

    Straumann Standard Plus SLA implants

    (Institut Straumann AG, Waldenburg, Swit-zerland). The implant placement was planned

    based on pre-surgical clinical and radio-

    graphic assessment. The implants were placed

    in a three-dimensional position described by

    Buser and colleagues (Buser et al. 2004). A

    bone augmentation procedure was carried out

    if (i) implant neck remained uncovered or (ii)

    the buccal bone plate was  

    PES   ≥  6), and unfavorable rate (PES   <  6) (Bel-

    ser et al. 2009; Cosyn et al. 2012).

    Clinical assessment

    The survival rate was defined as the percent-

    age of the implants remained in the oral cav-

    Fig. 1.  Flow chart of clinical procedures.Fig. 2.  The fabrication of provisional plastic crowns.

    2 |   Clin. Oral Impl. Res.  0,  2014 / 1–6   © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

    Gu et al Evaluation of soft tissue alteration

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    ity. Both biological and mechanical complica-

    tions were recorded. In addition, the follow-

    ing clinical variables were assessed: gingival

    biotype (Muller et al. 2000), modified plaque

    index (mPI), probing pocket depth (PPD),

    modified bleeding index (mBI). All the mea-

    surements were made by the same dentist

    using a periodontal probe (15 UNC/CP-11.5B

    Screening Color-Coded Probe, Hu-Friedy)

    (Mombelli et al. 1987).

    Follow-up assessment

    Patients were re-called for clinical and

    esthetic assessment at 1-year and 2-year after

    crown placement, and the indices of mPI,

    PPD, mBI, and PES/WES were recorded.

    Statistical methods

    Data analysis was performed using a statisti-

    cal software package STATA (version 11.0;

    StataCorp, College Station, TX, USA). Non-

    normally distributed data (mBI, mPI, PPD,and PES/WES) were analyzed using Wilcoxon

    signed-rank test. The intraclass correlation

    coefficient was used to determine the interex-

    aminer reliability. Wilcoxon rank-sum test

    was used to analyze the mean PES value and

    PES changing in patients with different graft

    procedures and gingival biotypes. The

    reported   P  values were two-sided. Statistical

    significance was set at 5%.

    Results

    After two-year follow-up, two patients were

    excluded because they declined to come back

    for the follow-up examination. At last,

    38 patients were included in this analysis.

    Table 1 shows the demographic features of

    all the subjects.

    The interclass correlation coefficient of the

    mean PES/WES value given by two orthodon-

    tists was 0.85 at baseline, 0.82 at 1-year fol-

    low-up, and 0.82 at 2-year follow-up.

    Table 2 shows the mean PES/WES value

    from baseline to 1-year follow-up. PES/WES

    significantly increased from 13.79 to 14.87 at1-year follow-up (P   <  0.01). In detail, the

    mean value of mesial and distal papilla, cur-

    vature and PES also increased significantly at

    1-year follow-up. The mean value of margin

    level and root convexity/color/texture sligh-

    tly increased, but both did not reach

    statistically significance.

    Table 3 shows the mean PES/WES value

    from 1-year follow-up to 2-year follow-up.

    PES/WES showed steady improvement (from

    14.87 to 14.96) at 2-year follow-up (P   =  0.40).

    In detail, the mean value of mesial and distal

    papilla, curvature, root convexity/color/tex-

    ture, and PES showed steady improvement at

    2-year follow-up. The mean value of margin

    level decreased slightly. And none parameters

    showed statistically significantly difference

    from 1-year follow-up to 2-year follow-up.

    Fig 3 shows one typical example of all the

    subjects included in the study.

    Table 4 shows PES frequency at baseline,

    1-year, and 2-year follow-up. The perfect rate

    (PR) increased from 2.63% to 34.21% after 2-

    year follow-up. The acceptable rate (AR)

    decreased from 78.95% to 59.21%. The unfa-

    vorable rate (UR) decreased from 18.42% to

    6.58%.

    Table 5 shows influence of variables on

    esthetic outcome of peri-implant soft tissue.

    Mean PES value did not show significant

    difference between patients with thick and

    thin biotype at baseline (P   =   0.27). However,

    patients with thick biotype could achieve sig-

    nificantly higher mean PES value at follow-

    up (P   =  0.02). In addition, PES changing value

    was higher in patients with thick biotype

    (P   =   0.03). Graft procedure had an unfavor-

    able effect on mean PES value both at base-

    line and at follow-up (P   <   0.01). However,

    similar PES changing value was found in

    patients with or without graft (P   =  0.44).

    No implants were lost during the observa-

    tion period, representing the survival rate

    was 100%. Three patients experienced peri-

    implant infection. All the three patients had

    undergone guided bone regeneration (GBR

    procedure due to the insufficient bone vol-

    ume. Thus, the biological complication rate

    was 7.9%. Two patients showed significant

    improvement after debridement. One patient

    showed recession of mid-facial mucosa and

    exposure of neck metal. No mechanical com-

    plications have occurred during the observa-

    tion period.

    Table 6 shows the change of clinical

    parameters from baseline to follow-up. No

    significant difference was found with the

    Table 1.   Summary of patient characteristics

    Mean age in years 31.3(19 – 58)

    Male/female ratio 22/16

    Patient need graft/not graft 24/14

    Implant site location: I1/I2/C 12/18/8

    Implant diameter: 3.3 mm/4.1 mm 20/18

    Implant length: 10 mm/12 mm 12/26

    I1, first incisor; I2, second incisor; C, cannine.

    Table 2.   Mean pink esthetic score/white esthetic score value from baseline to 1-year follow-upmean (median)   SD

    Baseline(n  =  38) 1-year (n   =  38)

    Mesial papilla 1.34 (1)    0.48 1.68 (2)     0.47   P  <   0.01*

    Distal papilla 1.03 (1)    0.16 1.42 (1)     0.50   P  <   0.01*

    Margin level 1.34 (1)    0.58 1.39 (1)     0.68   P  =   0.53

    Curvature 1.58 (2)    0.50 1.84 (2)     0.37   P  =   0.02*Root/color/texture 1.16 (1)    0.37 1.24 (1)     0.59   P  =   0.41

    PES 6.45 (7)    1.16 7.58 (8)     1.51   P  <   0.01*

    Form 1.58 (2)    0.50 1.55 (2)     0.49   P  =   0.96

    Outline 1.34 (1)    0.48 1.32 (1)     0.53   P  =   0.32

    Color 1.29 (1)    0.46 1.28 (1)     0.45   P  =   0.99

    Texture 1.50 (1)    0.51 1.49 (1)     0.53   P  =   0.57

    Translucency 1.63 (2)    0.49 1.66 (2)     0.48   P  =   0.16

    WES 7.34 (8)    1.26 7.29 (8)     1.11   P  =   0.94

    PES/WES 13.79 (14)    2.25 14.87 (15)     2.21   P  <   0.01*

    *Statistically significant difference from baseline to follow-up.

    Table 3.   Mean pink esthetic score/white esthetic score value from 1-year follow-up to 2-year fol-low-up mean (median)    SD

    1-year (n   =  38) 2-year (n  =  38)

    Mesial papilla 1.68 (2)    0.47 1.72 (2)     0.43   P  =   0.08

    Distal papilla 1.42 (1)    0.50 1.46 (1.5)     0.50   P  =   0.18

    Margin level 1.39 (1)    0.68 1.38 (1)     0.65   P  =   0.99

    Curvature 1.84 (2)    0.37 1.87 (2)     0.40   P  =   0.33

    Root/color/texture 1.24 (1)    0.59 1.28 (1)     0.49   P  =   0.19

    PES 7.58 (8)    1.51 7.71 (8)     1.38   P  =   0.07

    Form 1.55 (2)    0.49 1.54 (2)     0.50   P  =   0.46

    Outline 1.32 (1)    0.53 1.29 (1)     0.50   P  =   0.55

    Color 1.28 (1)    0.45 1.32 (1)     0.45   P  =   0.32

    Texture 1.49 (1)    0.53 1.47 (1)     0.51   P  =   0.98

    Translucency 1.66 (2)    0.48 1.63 (2)     0.50   P  =   0.32

    WES 7.29 (8)    1.11 7.25 (8)     1.18   P  =   0.71

    PES/WES 14.87 (15)    2.21 14.96 (16)     2.12   P  =   0.40

    None parameters showed statistically significant difference.

    ©  2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd   3 |  Clin. Oral Impl. Res.  0,  2014 / 1–6

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    passage of time in all three parameters. The

    gingival biotype assessment showed thick/

    thin ratio was 28/10.

    Discussion

    The present study used PES/WES to evaluate

    the esthetic outcome and alterations of peri-implant soft tissue using tissue-level implant

    system. Several studies have demonstrated

    the reliability and reproducibility of the PES/

    WES index in clinical esthetic assessment

    (Vilhjalmsson et al. 2011; Hof et al. 2013). In

    addition, it has also been proved that the

    changing of mean PES value is suitable to

    assess the stability of peri-implant soft tissue

    (Cho et al. 2010; Dierens et al. 2013).

    In present study, the implant shoulder was

    positioned about 1 mm apical to the cement – 

    enamel junction of the contralateral tooth.

    Implant position is believed to play an impor-tant role in implant esthetic outcomes. This

    may contribute to the favorable mean PES/

    WES value (7.71/7.25) at 2-year examination

    in this study. 26 patients received an imme-

    diate, single-tooth Morse taper connection

    implant (Leone implant System, Florence,

    Italy) in esthetic area (Mangano et al. 2012).

    At the 2-year examination, the mean PES/

    WES value was 14.30 (7.30/7.00). 20 patients

    received a bone-level implant treatment in

    esthetic area (Buser et al. 2009). At the 1-year

    examination, the mean PES/WES value was

    16.75 (8.10/8.65). This may indicate that tis-

    sue-level implant systems can also achieve

    favorable short-term esthetic outcome of sin-

    gle implant treatment on the premise of

    accurate implant placement depth.

    Implant crown features were assessed by

    WES score. The parameters of form,

    outline, color, texture, and translucency were

    assessed respectively. Good visual appearance

    had been achieved (WES   >   7). As the WES

    score is strongly related to the prosthetic

    design and quality, we pay more attention to

    the PES score.

    In this study, baseline assessment was

    performed two days later to avoid the inter-

    ference of pressure caused by immediately

    crowns placement. Spontaneous improve-

    ment in mean PES value was observed after

    one year follow-up and the slowdown of the

    improvement was observed at the second

    year follow-up.

    Mesial and distal papilla showed signifi-

    cant improvement during the observation

    period. This observation may be due to the

    relatively high bone level at the adjacent nat-

    ural teeth as only patients with single gap

    were included, for it is strongly believed that

    the extent of papillae fill surrounding an

    implant-supported restoration is principally

    decided by the bone level at the adjacent

    teeth (Chow & Wang 2010; Singh et al.

    2013).

    The curvature of soft tissue also showed

    significant improvement during the observa-

    tion period. It has been proven that peri-

    implant soft tissue is still in remodeling

    phase after abutment and crown attachment

    (Priest 2003; Schropp et al. 2005). With the

    relief of the pressure, the soft tissue may

    become relatively more mature and healthier

    with the time. This may probably explain

    why the soft tissue curvature score increased

    significantly.

    The margin level and root convexity/color/

    texture of soft tissue did not show significant

    difference during the observation period. The

    score of margin level even slightly decreased

    at 2-year follow-up compared with score at 1-

    year follow-up. This result is a little different

    from our previous study using the same

    implant systems (Lai et al. 2008). Only

    patients with sufficient bone volume were

    included in that study. Significant improve-

    ment in margin-level score was reported after

    6 – 8 months follow-up. Recession of mid-

    facial mucosa caused by peri-implant infec-

    tion in three subjects may explain the differ-

    Table 4.  Pink esthetic score frequency (in percent)

    PES score

    Baseline 1 year 2 years

    No. % No. % No. %

    0 0 0 0 0 0 0

    1 0 0 0 0 0 0

    2 0 0 0 0 1 1.32

    3 2 2.63 0 0 1 1.32

    4 2 2.63 4 5.26 0 0

    5 10 13.16 4 5.26 3 3.95

    6 22 28.95 6 7.89 2 2.63

    7 26 34.21 12 15.79 19 25.00

    8 12 15.79 30 39.47 24 31.58

    9 2 2.63 16 21.05 24 31.58

    10 0 0 4 5.26 2 2.63

    Total 76 100 76 100 76 100

    Perfect rate 2 2.63 20 26.32 26 34.21

    Acceptable rate 60 78.95 48 63.16 45 59.21

    Unfavorable rate 14 18.42 8 10.52 5 6.58

    (a)

    (b)

    (c)

    Fig 3.  (a) Baseline, (b) One year, and (c) 2-year result of

    a representative case. The pink esthetic score/white

    esthetic score score was (a) 7/9, (b) 9/9, (c) 9/9.

    Table 5.  Influence factors of pink esthetic score index mean (median)   SD

    PES at bas eline PES at 2 years PES changing

    Patients with thick biotype (n  =  28) 6.57 (7)    1.26 8.18 (8)    0.85 1.61 (1.5)    0.95

    Patients with thin biotype (n   =  18) 6.20 (6)    0.79 6.75 (6)    2.00 0.55 (0)     1.55

    P  =   0.27   P   =   0.02* P   =   0.03*

    Patients with graft (n  =  24) 5.92 (6)    1.06 7.31 (7)    1.45 1.40 (1)     1.47

    Patients without graft (n   =  14) 7.43 (7)    0.51 8.64 (8)    0.72 1.21 (1)     0.54

    P   <   0.01* P   <   0.01* P   =   0.44

    PES changing  =  PES at 2-year follow-up –  PES at baseline.*Statistically significant difference between groups.

    4 |   Clin. Oral Impl. Res.  0,  2014 / 1–6   © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd

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    ence. This agreed with the findings in previ-

    ous studies that higher biological complica-

    tion rate was found in patients with grafting

    (den Hartog et al. 2013; Santing et al. 2013).

    Among 38 patients in this study, 24 patients

    experienced grafting procedures combined

    with implant placement. The mean PES value

    in patients with grafting was significantly

    lower in those without grafting both at base-

    line and at follow-up. This implied that the

    grafting procedures might have an unfavorable

    effect on the esthetic outcome of peri-implant

    soft tissue. The less favorable pre-surgical sit-

    uation, scar tissue caused by additional surgi-

    cal procedures, higher complication rate, and

    resorption of graft materials may be the possi-

    ble reason for this result.

    However, similar alterations of mean PES

    value were found in patients with or without

    GBR in this study, and the mean PES value

    increased from 5.92 to 7.31 after 2-year fol-

    low-up. This indicated tissue-level implant

    systems could achieve spontaneous improve-

    ment in soft tissue visual appearance also in

    patients with GBR.

    It is believed that biologic width around

    one-piece tissue-level implants was more sim-

    ilar to natural teeth than that around two-

    piece bone-level implants (Hermann et al.

    2001). The disconnections and reconnections

    of abutments which are necessary in bone-

    level implant systems may disturb connec-

    tive tissue interaction and result a more api-

    cally positioned zone of connective tissue

    (Degidi et al. 2011). In addition, a recent pub-

    lished study showed tissue-level implants

    may present better long-term results in terms

    of peri-implant bone maintenance, as com-

    pared with bone-level implants (Chiapasco

    et al. 2014). This may explain the favorable

    outcome in our study and demonstrate that

    tissue-level implants are also suitable to sup-

    port single implant crowns in esthetic area.

    Several studies have demonstrated that

    thick gingivae have lower risk of recession of

    mid-facial margin-level and interdental papilla

    (Lee et al. 2011; Cabello et al. 2013). In this

    study, similar mean PES value was found in

    patients with thick or thin gingival biotype

    at baseline. After 2-year follow-up, patients

    with thick gingival biotype achieved more

    favorable esthetic outcome of peri-implant

    soft tissue. This means gingival biotype can

    be considered as prognostic factors for

    esthetic assessment.

    Besides the mean value, the existing indi-

    ces that categorize single features should also

    be analyzed with frequency analysis (Lang &

    Zitzmann 2012). It should be noted that PES/

    WES index should be classified as an ordinal

    data instead of a continuous data. Frequency

    analysis which reflects the discrete distribu-

    tion of data is important for ordinal data (Shi

    et al. 2014). In this study, the perfect rate at

    2-year follow-up was almost thirteen times

    as much as it at baseline. And the unfavor-

    able rate decreased after 2-year follow-up.

    The result of frequency analysis also con-

    firmed the improvement in esthetic out-

    come.

    Conclusion

    The results of the present study indicate that

    it is feasible to use tissue-level implant to

    support single crowns in esthetic area. Favor-

    able short-term esthetic outcome and stability

    of soft tissue around single implant crowns

    can be expected in patients with or withoutgraft. However, graft procedures might have

    an unfavorable effect on the esthetic out-

    come. Gingival biotype can be considered as

    prognostic factor for esthetic outcome. RCTs

    with long-term follow-up are needed to pro-

    vide evidence for the long-term stability of

    peri-implant soft tissue using tissue-level

    implant systems.

    Acknowledgement

    We would like to thank Sheng-hui Li (Shang-

    hai Jiaotong University, College of Medicine)

    for statistics consultation.

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    Gu et al Evaluation of soft tissue alteration