NCT05669560

Brief Summary

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.

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
13mo left

Started Jan 2023

Longer than P75 for early_phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Jan 2023Jun 2027

First Submitted

Initial submission to the registry

December 6, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 3, 2023

Completed
17 days until next milestone

Study Start

First participant enrolled

January 20, 2023

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

4.4 years

First QC Date

December 6, 2022

Last Update Submit

November 20, 2023

Conditions

PeriodontitisDiabetes Mellitus

Keywords

non surgical periodontal therapyscaling and root planing

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Change in Probing Pocket Depth(mm)

    Measured at baseline, 3, 6, 9months.

  • Change in Bleeding On Probing(%)

    Measured at baseline, 3, 6, 9months.

  • Change in Plaque Index (0-3).

    Measured at baseline, 3, 6, 9months.

  • Change in Clinical attachment levels(mm).

    Measured at baseline, 3, 6, 9months.

Study Arms (2)

Control group

NO INTERVENTION

Will receive SRP alone.

Test group

EXPERIMENTAL

Will receive SRP + PerioProtect ™.

Combination Product: PerioProtect ™= plastic tray +1.7% hydrogen peroxide

Interventions

PerioProtect ™= plastic tray +1.7% hydrogen peroxideCOMBINATION_PRODUCT

Subjects will receive PerioProtect ™ in adjunct to mechanical therapy. 15minutes, twice a day, for 3 months.

Test group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.
  • No SRP within the past 6 months.
  • Willingness to comply with study instructions and refrain from using oral hygiene products/ procedures outside the study.

You may not qualify if:

  • The researcher believes that it is not in the patient's best interest to stay in the study
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisDiabetes Mellitus

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • John Dmytryk, DDS, PhD

    The University of Oklahoma, College of Dentistry, Division in Periodontics

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2022

First Posted

January 3, 2023

Study Start

January 20, 2023

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

November 22, 2023

Record last verified: 2023-11