PeriodontitisEarly Phase 1Peroxide gelNCT05669560
Efficacy of Hydrogen Peroxide Gel on Periodontitis With Diabetes
A Early Phase 1 study testing PerioProtect ™= plastic tray +1.7% hydrogen peroxide in people with Periodontitis and Diabetes Mellitus, run by University of Oklahoma.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Diabetes Mellitus
- What is being tested?
- PerioProtect ™= plastic tray +1.7% hydrogen peroxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Jan 2023to 30 Jun 2027
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Periodontitis, Diabetes Mellitus
- Being tested
- PerioProtect ™= plastic tray +1.7% hydrogen peroxide
- Keywords
- non surgical periodontal therapy, scaling and root planing
- Medical subject headings
- Periodontitis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerioProtect ™= plastic tray +1.7% hydrogen peroxideCombination product
Subjects will receive PerioProtect ™ in adjunct to mechanical therapy. 15minutes, twice a day, for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Will receive SRP alone. |
| Test group | Experimental | Will receive SRP + PerioProtect ™. Receives: Combination Product: PerioProtect ™= plastic tray +1.7% hydrogen peroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 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: 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: 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: Measured at 9 months
Secondary outcomes (4)
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: 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: 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: 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: Measured at baseline, 3, 6, 9months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study start20 Jan 2023 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: The study team made the decision to not move forward with the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Perio Protect LLC
- Responsible party
- Sponsor
- Investigators
- John Dmytryk, DDS, PhD, Study chair, The University of Oklahoma, College of Dentistry, Division in Periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669560
- Sponsor's protocol ID
- Withdrawn
- Acronym
- Peroxide gel
- Status last verified
- Nov 2023
- First submitted
- 6 Dec 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrogen Peroxide Gel on Periodontal Ststus and Metabolic Control in Diabetic Patients: a Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05669560
- Acronym / sponsor ID
- Peroxide gel / Withdrawn
- Conditions
- Periodontitis, Diabetes Mellitus
- Keywords
- non surgical periodontal therapy, scaling and root planing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study team made the decision to not move forward with the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Perio Protect LLC
- Study start
- 20 Jan 2023 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Will receive SRP alone. |
| Test group | Experimental | Combination Product: PerioProtect ™= plastic tray +1.7% hydrogen peroxideWill receive SRP + PerioProtect ™. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PerioProtect ™= plastic tray +1.7% hydrogen peroxideSubjects will receive PerioProtect ™ in adjunct to mechanical therapy. 15minutes, twice a day, for 3 months. | Combination product | Test group |
Primary outcome
Change of HbA1C measured in percentage.
Time frame: Measured at baseline
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.
Change of HbA1C measured in percentage.
Time frame: Measured at 3 months
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.
Change of HbA1C measured in percentage.
Time frame: Measured at 6 months
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.
Change of HbA1C measured in percentage.
Time frame: Measured at 9 months
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.
4 secondary outcomes
Change in Probing Pocket Depth(mm)
Time frame: Measured at baseline, 3, 6, 9months.
Change in Bleeding On Probing(%)
Time frame: Measured at baseline, 3, 6, 9months.
Change in Plaque Index (0-3).
Time frame: Measured at baseline, 3, 6, 9months.
Change in Clinical attachment levels(mm).
Time frame: Measured at baseline, 3, 6, 9months.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Dmytryk, DDS, PhD study chair
The University of Oklahoma, College of Dentistry, Division in Periodontics
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing PerioProtect ™= plastic tray +1.7% hydrogen peroxide in people with Periodontitis and Diabetes Mellitus, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1C measured in percentage. (time frame: Measured at baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.