Efficacy of Hydrogen Peroxide Gel on Periodontitis With Diabetes (Peroxide gel)

Efficacy of Hydrogen Peroxide Gel on Periodontal Ststus and Metabolic Control in Diabetic Patients: a Randomized Control Trial

Periodontitis is a chronic infectious disease characterized by loss of tooth supporting periodontal structures and alveolar bone. In the U.S. and worldwide, periodontitis is the major cause of tooth loss in adults.

Type 2 Diabetes mellitus (T2DM) is a complex disease that affects 13-15 million Americans and is associated with a variety of serious complications. T2DM is well established as a strong systemic risk factor for periodontitis. The severity and prevalence of periodontitis is much higher in patients with diabetes. This relationship may be bi-directional.

Study Overview

• Status: Withdrawn
• Conditions: Diabetes Mellitus; Periodontitis
• Intervention / Treatment: Combination product: PerioProtect ™= plastic tray +1.7% hydrogen peroxide

Detailed Description

The primary treatment for periodontitis is scaling and root planing (SRP), which refers to the mechanical disruption and removal of bacteria and bacterial toxins from the affected tooth root surfaces. This procedure predictably reduces the bacterial load and produces marked improvement in clinical periodontal parameters, though not always complete resolution of the disease. Periodontal therapy may have some systemic benefits by reducing entry into the systemic circulation of pro inflammatory molecules and bacterial byproducts from the periodontal tissues. Since SRP alone is not always a completely effective treatment especially in advanced stages of periodontitis, a variety of adjunctive antimicrobial therapies such as local delivery of antimicrobial agents into periodontal pockets have been developed and employed to further reduce the bacterial load from periodontal pockets, with mixed results.

A recent innovation in the arena of local delivery antimicrobial agents is the PerioProtect ™ system (Perio Tray® and PerioGel® Perio Protect, St. Louis, MO). This consists of a closely fitting acrylic tray (similar to an athletic mouthguard), which is used to administer 1.7% hydrogen peroxide gel (Perio Gel®, QNT Anderson, Bismarck, ND) deep into the periodontal pocket and retain the gel in place for a sufficient time period (15 minutes) to effectively reduce the periodontal bacterial load. Studies to date have shown that when PerioProtect ™ is used as adjunct to conventional SRP, this system produces additional benefits in reducing the severity of periodontal disease. However, no studies have yet investigated the use of PerioProtect ™ in patients with T2DM and periodontitis.

Based on the concept of a bi-directional relationship of diabetes and periodontitis, the investigators hypothesize that successful management of periodontal infection in diabetics with the use of PerioProtect ™ will not only improve periodontal status, but also result in improved metabolic control of T2DM.

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Jaewon Kim, DDS, MSD, PhD; Phone Number: 716 604 4064; Email: Jaewon-Kim@ouhsc.edu
• Study Contact Backup: Name: Madhumati Ramachandrareddy, DDS; Phone Number: 470 364 0595; Email: madhumati-ramachandrareddy@ouhsc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Adults >18 , <80 year old with moderate to severe periodontitis as defined by the Word workshop criteria having Type II diabetes mellitus with HbA1 C levels of >6.5%.
2. No SRP within the past 6 months.
3. Willingness to comply with study instructions and refrain from using oral hygiene products/ procedures outside the study.

Exclusion Criteria:

• The researcher believes that it is not in the patient's best interest to stay in the study
• Based on the exclusion criteria, the patient becomes ineligible to participate
• Patient's medical condition requires interventions which preclude involvement in the study
• Patient does not follow study related instructions
• The study is suspended or canceled

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Will receive SRP alone.
Experimental: Test group; Will receive SRP + PerioProtect ™.	Combination product: PerioProtect ™= plastic tray +1.7% hydrogen peroxide; Subjects will receive PerioProtect ™ in adjunct to mechanical therapy. 15minutes, twice a day, for 3 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of HbA1C measured in percentage.	To investigate the efficacy of locally delivered 1.7% hydrogen peroxide gel (Perio Gel®)as an adjunct to mechanical periodontal therapy on glycemic control in periodontitis patients with Type 2 diabetes mellitus.	Measured at baseline
Change of HbA1C measured in percentage.	To investigate the efficacy of locally delivered 1.7% hydrogen peroxide gel (Perio Gel®)as an adjunct to mechanical periodontal therapy on glycemic control in periodontitis patients with Type 2 diabetes mellitus.	Measured at 3 months
Change of HbA1C measured in percentage.	To investigate the efficacy of locally delivered 1.7% hydrogen peroxide gel (Perio Gel®)as an adjunct to mechanical periodontal therapy on glycemic control in periodontitis patients with Type 2 diabetes mellitus.	Measured at 6 months
Change of HbA1C measured in percentage.	To investigate the efficacy of locally delivered 1.7% hydrogen peroxide gel (Perio Gel®)as an adjunct to mechanical periodontal therapy on glycemic control in periodontitis patients with Type 2 diabetes mellitus.	Measured at 9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Probing Pocket Depth(mm)	To determine if the use of PerioProtect ™ as an adjunct to mechanical therapy produces additional improvement in periodontal status as compared to conventional periodontal therapy (SRP) alone.	Measured at baseline, 3, 6, 9months.
Change in Bleeding On Probing(%)	To determine if the use of PerioProtect ™ as an adjunct to mechanical therapy produces additional improvement in periodontal status as compared to conventional periodontal therapy (SRP) alone.	Measured at baseline, 3, 6, 9months.
Change in Plaque Index (0-3).	To determine if the use of PerioProtect ™ as an adjunct to mechanical therapy produces additional improvement in periodontal status as compared to conventional periodontal therapy (SRP) alone.	Measured at baseline, 3, 6, 9months.
Change in Clinical attachment levels(mm).	To determine if the use of PerioProtect ™ as an adjunct to mechanical therapy produces additional improvement in periodontal status as compared to conventional periodontal therapy (SRP) alone.	Measured at baseline, 3, 6, 9months.

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Perio Protect LLC
• Investigators: Study Chair: John Dmytryk, DDS, PhD, The University of Oklahoma, College of Dentistry, Division in Periodontics

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 6, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: scaling and root planing; non surgical periodontal therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Anti-Infective Agents, Local; Anti-Infective Agents; Hydrogen Peroxide
• Other Study ID Numbers: Withdrawn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes