6-month Multi-clinic Treatment of Periodontal Disease ... · Peridontal surgery within 6 months...
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Transcript of 6-month Multi-clinic Treatment of Periodontal Disease ... · Peridontal surgery within 6 months...
Purpose
Introduction
Abstract
Methods
Objectives: Determine whether use of PerioProtect Method ® (PPM) in combination with scaling and
root-planing (SRP) over 6-months would result in improvements in outcome measures in patients with
periodontal disease (PD).
Methods: 44 patients with mild to severe PD were treated by 4 dentists in separate clinics. Dentists
were specially trained in PerioProtect® system. Subject distribution was: Dentist-1, 11 patients (7 male;
ages 52 13); Dentist-2, 15 patients (3 male; ages 57 15); Dentist-3, 15 patients (4 male; ages 55 14);
Dentist-4, 3 patients (1 male; ages 49 20). All patients underwent baseline evaluation for PPD per
tooth (6 sites per tooth) and BoP (dichotomous per site). Prior to treatment all patients received
instruction on supra-gingival care and the use of PPM. Each Dentist administered a specific
combination of PPM and SRP treatment: Group A (7 male; 9 female; age 53 13) received whole mouth
SRP prior to use of PPM and Group B (7 male; 21 female; age 55 14) received PPM first followed by
site-specific SRP. Changes in PPD and BoP for all patients were reassessed after a 6 month period.
Results: Baseline averages indicated no significant difference in PPD between Groups A and B
(p>0.232); however there was significantly more BoP in patients in Group A at baseline than Group B
(p=0.003). At 6 months, PPD values for 0-5mm pockets for all patients significantly improved from
baseline (p<0.001) and differences between Dentists were not significant (p>0.360). At 6 months all
patients had significantly decreased BoP (p<0.01) with no significant differences noted between
Dentists (p>0.556) or between treatment Groups (p>0.361).
Conclusions: An appropriately trained general Dentist can effectively administer PPM. PPM is
effective for improving PPDs and BoP within 6 months in mild to moderate cases of periodontal disease
regardless of whether full mouth SRP is followed by PPM or PPM is followed by site-specific SRP.
Treating physicians – all treating dentists received prior training in administering
the PPM®
Dentist 1 treated 11 patients (7 male, 4 female; age 52 13)
Dentist 2 treated 15patients (3 male, 12 female; age 57 15)
Dentist 3 treated 15 patients (4 male, 11 female; age 55 14)
Dentist 4 treated 3 patients (1 male, 2 female; age 49 20)
Total patients treated were 44.
Inclusion criteria:
Presence of gingivitis or mild to severe periodontal disease determined
via periodontal examination
Exclusion criteria:
SRP treatment within 3 months prior to enrollment
Peridontal surgery within 6 months prior to enrollment
Current orthodontia
Physical or mental inability to utilize the dental trays for PPM®
Less than 10% bleeding on probing (BoP) at baseline
More than 90% of the pocket probing depths (PPDs) fell into the 0-3mm
category
Periodontal assessment
Performed during the initial visit and at all follow-up visits.
Assessment measures were performed at 6 sites per tooth and included
PPD (rated on a mm scale) and BoP (rated as dichotomous)
Treatment application
Group assignment was based on treating dentist’s clinical decision
making:
Group A: Received full-mouth SRP prior to use of PPM®
Group B: Received PPM® first, followed by quadrant specific SRP
Perio Trays were custom made and delivered to each patient (Figure 2)
All patients received instruction on supra-gingival care and use of PPM®
All eligible participants signed an informed consent form prior to
participating
Data analysis:
BoP data was converted to percentage data
PPD data was stratified for some analyses:
0-3 mm – closed pockets
4-5 mm – mild disease
6-7 mm – moderate disease
> 8 mm – severe disease
Independent t-tests were used for between treatment groups
One way ANOVAs were used for comparison of dentists
Results
Baseline
No significant difference in PPD were seen between Groups A and B
(p values ranged from 0.232 to 0.592; see Figure 4)
Significantly more BOP was seen in Group A at baseline than Group B
(p=0.003; see Figure 4)
6 months:
PPD values for 0-5mm pockets for patients in Group A and Group B
significantly improved from baseline (p<0.001 for both groups).
All patients had significantly decreased BoP when compared to baseline
(p<0.01), with no significant differences noted between Dentists
(p>0.556) or between treatment groups (p>0.361).
Appropriately trained dentists can effectively administer and oversee the PPM® protocol.
PPM® is an effective adjunct treatment for improving PPDs and BoP after 6 months of
care in patients with mild to moderate cases of periodontal disease regardless of
whether full mouth SRP is followed by PPM® or PPM® is followed by quadrant-specific
SRP.
Acknowledgements
References
6-month Multi-clinic Treatment of Periodontal Disease Using Topical Oxidizing Agents C.M. MITCHELL1, D. KELLER2, L. WEAKS1, and B.J. SINDELAR1,
1Division of Physical Therapy, Ohio University, Athens, OH, 2Perio Protect LLC, Saint Louis, MO
Figure 4. Group A change in PPD from baseline to 6 month follow-up regardless of dentist.
Figure 5. Group B Change in PPD from Baseline to 6 month follow-up regardless of dentist.
0
20
40
60
80
Baseline 6 months
36.6%
9.2%
52.4%
1.4%
78.5%
11.3%
Dr. 1
Dr. 2
Dr. 4
Treatment Group
Total # of Probing
Sites
Sites that worsened
with treatment
Sites that remained the same
with treatment
Sites that Improved
with treatment
Group A
373 6 (2%)
63 (17%)
304 (81%)
Group B
1027 28 (3%)
95 (9%)
904 (88%)
Figure 6. Presentation of change in Pockets >3mm from baseline to 6 months.
Periodontal disease is a chronic gram-negative anaerobic infection of the tooth-
supporting structures (gum and bone). The gradual buildup of bacteria leads to the
formation of plaque and tartar biofilms on the surface of the teeth (Figure 1, Figure 7).
If left untreated bacterial toxins combined with the body’s immune response to
infection can lead to gingivitis and eventually to periodontitis. Periodontal disease is
characterized by inflammation of the gums, bleeding, loss of attachment, increased
depth of periodontal pocket and eventual tooth loss. National clinical oral
epidemiological studies estimate that approximately 75% of the general adult
population in the US have some form of periodontal disease, with 20-30% having a
severe form of the disease.[6]
Current treatment of periodontal disease includes frequent brushing and flossing
(traditional therapy), scaling and root planning (mechanical therapy) and antimicrobial
delivery systems.[2] Despite inconsistent and ineffective long-term results, scaling and
root planning (SRP) is considered the gold standard treatment. Over the past 2
decades, local antibiotic treatments have been added as an adjunct to SRP regimens
resulting in modest improvements to probing depth and clinical attachment levels.[5]
However the question remains as to whether these improvements are clinically
relevant.[1] In addition, these therapies remain inadequate interventions because they
fail to maintain the long-term removal of the anaerobic bacteria that cause periodontal
disease. [3,4,8,9]
The PerioProtect Method® (PPM) combines a non-invasive chemical therapy with
mechanical debridement. The chemical treatment commonly uses a prescribed
solution of hydrogen peroxide (H2O2), an oxidizing agent that debrides the slimy
protective coating of the biofilm and its underlying layers and also cleanses the oral
wounds. By introducing oxygen into the anaerobic periodontal environment, the
harmful anaerobic bacteria can no longer survive.
To evaluate the effects of PerioProtect Method ® (PPM) over a 6-month period on
the clinical outcome measures of patients with periodontal disease.
We would like to thank Tanya Dunlap, PhD, for her assistance with providing and verifying
patient data throughout the study period. We would also like to thank Lan Nguyen PT,
DPT, and Lindsey Jobe PT, DPT, for allowing access to their preliminary 3 month study
data.
81.0%
17.9%
1.0% 0.1%
BASELINE
0-3 mm
4-5 mm
6-7 mm
>8 mm
93.9%
5.7% 0.3% 0.0%
6 MONTH
0-3 mm
4-5 mm
6-7 mm
>8 mm 83.3%
14.9%
1.6% 0.2%
BASELINE
0-3 mm
4-5 mm
6-7 mm
>8 mm
95.9%
3.4%
0.6%
0.1%
6 MONTH
0-3 mm
4-5 mm
6-7 mm
>8 mm
Conclusion
Pocket Probing Depth Group A Group B
0-3 mm 80.9 ± 15% 83.3 ± 18.3%
4-5 mm 17.9 ± 13.1% 14.9 ± 14.6%
6-7 mm 1.0 ± 2.6% 1.6 ± 4.8%
≥8 mm 0.1 ± 0.3% 0.2 ± 0.8%
Bleeding on Probing (BoP) Group A Group B
49.4 ± 30.9% * 26.8 ± 20.9% *
Figure 3. Baseline averages for PPD and BoP regardless of dentist. * indicates statistical significance
Figure 8. Group A change in BoP from baseline to 6 month follow-up. Each column represents the results of a
different doctor.
Figure 9. Group B Change in BoP from baseline to 6 month follow-up. Each column represents the results
of a different doctor.
1. Flemmig, T. 2006. Locally delivered antimicrobials adjunctive to scaling and root planning provide additional PD reduction and CAL
gain in treatment of chronic periodontitis. Journal of Evidence based Dental Practice. 6; 220-1.
2. Graham, L. 2003. An emerging new standard of care: initial and continued treatment for patients with signs and symptoms of
active periodontal disease. General Dentistry. 51(6), 570-7.
3. Greenstein, G. 2004. The role of local drug delivery in the treatment of chronic periodontitis. Things you should know. Dentistry
Today. 23(3), 110-5.
4. Hanes, PJ, Purvis, JP. 2003. Local anti-infective therapy: pharmacological agents. A systematic review. Annals of periodontology.
8(1), 79-98.
5. Herrera, D, Sanz, M, Jepsen, S, Needleman, I, Roldán, S. 2002. A systematic review on the effect of systemic antimicrobials as an
adjunct to scaling and root planing in periodontitis patients. Journal of Clinical Periodontology. 29 (Suppl 3), 136-59; discussion
160-2.
6. Humphrey, L. et al, (2008). Periodontal disease and coronary heart disease incidence: A systematic review and meta-analysis.
Journal of General Internal Medicine, 23(12), 2079-2086.
7. Journal American Dental Association. Feb 2003. Treating periodontal disease - Scaling and Root Planing. 134, pg 259.
8. Mombelli, A., & Samaranayake, L. (2004). Topical and systemic antibiotics in the management of periodontal diseases.
International Dental Journal, 54(1), 3-14.
9. Swierkot, K, Nonnenmacher, CI, Mutters, R, Flores-de-Jacoby, L, Mengel, R. 2009. One-stage full-mouth disinfection versus
quadrant and full-mouth root planing. Journal of Clinical Periodontology. 36(3), 240-9.
10. Steele, C, Sindelar, BJ, Keller DC. 2007. C-reactive protein changes during Perio Protect treatment of periodontal disease. Journal
of Dental Research. 1195, 86 (Spec Iss A): (www.dentalresearch.org).
11. Wentz, LE, Blake, AM, Keller, DC, Sindelar, BJ. 2006. Initial study of the Perio Protect TM treatment for periodontal disease.
Journal of Dental Research. 85 (Spec Iss A): 1164, (www.dentallresearch.org).
Figure 2. Sample prescription medical Perio Trays®. The tray is loaded with the selected medication, in this
project 1.7% H2O2 gel. Photo on right demonstrates tray in place. Treatment recommendation to all patients was
10 minute wear sessions twice daily.
Figure 7. Sample before and after treatment images of randomly selected patient
Figure 1. Perio Protect Method
0
10
20
30
40
Baseline 6 months
29.3%
7.6%
38.6%
3.6%
18.5%
1.7%
Dr. 1
Dr. 2
Dr. 3