Intrabony Defects in Chronic PeriodontitisPhase 2NCT02048761
Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Chronic Periodontitis
A Phase 2 study testing 1 % Metformin gel in people with Intrabony Defects in Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
Trial summary
This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrabony Defects in Chronic Periodontitis
- What is being tested?
- 1 % Metformin gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2013to Feb 2014
- Phase
- Phase 2
- 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Systemically healthy subjects
- Sites with probing depth (PD) ≥5 mm
- Clinical attachment level (CAL) ≥4 mm
- Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Who cannot join
- Patients with known systemic disease
- Known or suspected allergy to the MF/ biguanide group
- Patients on systemic MF or other oral antidiabetic therapy
- Patients with aggressive periodontitis
- Patients with diabetes
- Use of tobacco in any form
Show all 9Show fewer
- Alcoholism
- Immunocompromised patients
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
India1 site
Government Dental College and Research Institute
Bangalore, Karnataka, 560002
About this study
Official title: Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.
Read the detailed description
Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.
Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.
- Being tested
- Placebo gel, 1 % Metformin gel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo gelDrug
After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula
1 % Metformin gelDrug
After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Placebo comparator | After debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula. Receives: Drug: Placebo gel |
| 1% Metformin | Active comparator | After debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula. Receives: Drug: 1 % Metformin gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Defect depth reduction
The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.
Measured: Baseline to 6 months
Secondary outcomes (4)
Probing depth
Probing depth is measured from baseline to 3 months and 6 months in both control and test group.
Measured: Baseline to 6 months
Clinical attachment level
Clinical attachment level is measured from baseline to 3 months and 6 months in both control and test group.
Measured: Baseline to 6 months
Modified sulcular bleeding index
Modified sulcular bleeding index is measured from baseline to 3 months and 6 months in both control and test group.
Measured: Baseline to 6 months
Plaque index
Full mouth and site specific plaque index is measured from baseline to 3 months and 6 months in both control and test group.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrabony Defects in Chronic PeriodontitisStudies of the same condition, open and under way.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government Dental College and Research Institute, Bangalore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore
- Investigators
- A R Pradeep, M.D.S., Principal investigator, Govt Dental College & Research Inst, Bangalore.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02048761
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2013-14/B
- Status last verified
- Feb 2014
- First submitted
- 23 Jan 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locally Delivered 1% Metformin Gel in the Treatment of Intrabony Defects in Subjects With Chronic Periodontitis : A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02048761
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2013-14/B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 29 Jan 2014 (estimated)
- 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.
This study was designed as a randomized, controlled clinical trial to evaluate the efficacy of 1% MF gel as local drug delivery in adjunct to SRP for the treatment of intrabony defects in chronic periodontitis in comparison with placebo gel.
Detailed description
Background: Metformin (MF) belonging to the class biguanide, is a first-line therapy for type 2 diabetes mellitus, and is one of the most commonly prescribed oral hypoglycemic drug worldwide. MF has shown to posses bone forming and bone sparring actions. The present study was designed to investigate effectiveness of MF, 1 % in an indigenously prepared biodegradable controlled-release gel as, as an adjunct to scaling and root planing (SRP) in treatment of chronic periodontitis subjects with intrabony defects.
Materials and Methods: Sixty five subjects were categorized into two treatment groups: SRP plus 1% MF and SRP plus placebo. Clinical parameters were recorded at baseline and at 3 and 6 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), probing depth (PD), and clinical attachment level (CAL). At baseline and after 6 months, radiologic assessment of intrabony defect (IBD) fill was done using computer-aided software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Placebo comparator | Drug: Placebo gelAfter debridement, placebo gel was applied into the periodontal pockets with a syringe and a blunt canula. |
| 1% Metformin | Active comparator | Drug: 1 % Metformin gelAfter debridement, 1% Metformin gel was applied into the periodontal pockets with a syringe and a blunt canula. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Systemically healthy subjects
- Sites with probing depth (PD) ≥5 mm
- Clinical attachment level (CAL) ≥4 mm
- Vertical bone loss ≥3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months were included
Key exclusion criteria (9 listed)
- Patients with known systemic disease
- Known or suspected allergy to the MF/ biguanide group
- Patients on systemic MF or other oral antidiabetic therapy
- Patients with aggressive periodontitis
- Patients with diabetes
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 |
|---|---|---|
| Placebo gelAfter debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula | Drug | Placebo Group |
| 1 % Metformin gelAfter debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula. | Drug | 1% Metformin |
Primary outcome
Defect depth reduction
Time frame: Baseline to 6 months
The primary outcome of the study is to determine the defect depth reduction by 1% metformin gel radio-graphically and compare the outcome with control group.
4 secondary outcomes
Probing depth
Time frame: Baseline to 6 months
Clinical attachment level
Time frame: Baseline to 6 months
Modified sulcular bleeding index
Time frame: Baseline to 6 months
Plaque index
Time frame: Baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2014.
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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.
A R Pradeep, M.D.S. principal investigator
Govt Dental College & Research Inst, Bangalore.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 1 % Metformin gel in people with Intrabony Defects in Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Defect depth reduction (time frame: Baseline to 6 months). 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 3 Mar 2014.