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