Chronic PeriodontitisPhase 2/3NCT02580331

1% Metformin Gel in the Treatment of Class II Furcation Defects

A Phase 2/3 study testing SRP and 1% metformin in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Chronic Periodontitis
What is being tested?: SRP and 1% metformin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 64 participants
Where: 1 siteIndia
Study dates: Nov 2014to Sep 2015
Phase: Phase 2/3
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 30 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD≥ 5 mm and horizontal PD≥3 mm following phase I therapy (SRP)

Who cannot join

patients with known systemic disease; patients with known or suspected allergy to the MF; patients receiving systemic MF therapy; patients with aggressive periodontitis; patients using tobacco in any form; patients with alcoholism; patients who were immunocompromised; pregnant or lactating females.

Trial locations and contacts

1 site in 1 country.

India1 site

Government Dental College and Research Institute
Bangalore, Karnataka, 560002

Other trials in India

About this study

Official title: 1% Metformin Gel as Local Drug Delivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial

Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Read the detailed description

Background: Metformin (MF), a biguanide group of anti-diabetic drug has been shown to enhance osteoblasts differentiation and inhibit osteoclast differentiation in vitro, thus may exhibit a favourable effect on alveolar bone. The present study aims to explore the efficacy of 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of Class II furcation defects in comparison with placebo gel.

Methods: Sixty four patients with single mandibular buccal class II furcation defects were categorized into two treatment groups: SRP plus 1% MF (group 1) and SRP plus placebo (group 2). Clinical parameters were recorded at baseline, 3 months, 6 months, and 9 months, and radiographic parameters were recorded at baseline, 6 months, and 9 months. Defect fill at baseline, 6 months, and 9 months was calculated on standardized radiographs using image analysis software.

Conditions: Chronic Periodontitis
Being tested: SRP and placebo, SRP and 1% metformin
Medical subject headings: Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SRP and placeboDrug
Also called Group 1
Placement of placebo gel into classII furcation defects after scaling and root planing
SRP and 1% metforminDrug
Also called Group 2
Placement of 1% metformin gel into classII furcation defects after scaling and root planing

Study groups in NCT02580331
Study group	Role	What they receive
SRP and placebo	Placebo comparator	Oral prophylaxis followed by placement of placebo gel Receives: Drug: SRP and placebo
SRP and 1% metformin	Active comparator	Oral prophylaxis followed by placement of 1% metformin gel Receives: Drug: SRP and 1% metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

Bone defect fill
Assesed in percentage
Measured: baseline to 9 months

Secondary outcomes (5)

modified sulcus bleeding index
scale 0-3
Measured: baseline to 9 months
plaque index
scale 0-3
Measured: baseline to 9 months
pocket probing depth
measured in mm
Measured: baseline to 9 months
relative vertical clinical attachment level
measured in mm
Measured: baseline to 9 months
relative horizontal clinical attachment level
measured in mm
Measured: baseline to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2014Sep 2015

First posted20 Oct 2015 (estimated)
Study startNov 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02580331
Sponsor's protocol ID: GDCRI/ACM/PG/PhD/2/2013-2014S
Status last verified: Oct 2015
First submitted: 18 Oct 2015
Last updated: 20 Oct 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
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RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

All Chronic Periodontitis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 1% Metformin Gel as Local Drug Delivery in the Treatment of Class II Furcation Defects: A Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT02580331
Acronym / sponsor ID: GDCRI/ACM/PG/PhD/2/2013-2014S
Conditions: Chronic Periodontitis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: Government Dental College and Research Institute, BangaloreUniversity, hospital or other
Study start: Nov 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 20 Oct 2015 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
SRP and placebo	Placebo comparator	Drug: SRP and placeboOral prophylaxis followed by placement of placebo gel
SRP and 1% metformin	Active comparator	Drug: SRP and 1% metforminOral prophylaxis followed by placement of 1% metformin gel

Who may qualify

Ages: 30 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

the presence of buccal Class II furcation defects in endodontically vital, asymptomatic mandibular first molars with a radiolucency in the furcation area on an intraoral periapical radiograph with PD≥ 5 mm and horizontal PD≥3 mm following phase I therapy (SRP)

Key exclusion criteria (1 listed)

patients with known systemic disease; patients with known or suspected allergy to the MF; patients receiving systemic MF therapy; patients with aggressive periodontitis; patients using tobacco in any form; patients with alcoholism; patients who were immunocompromised; pregnant or lactating females.

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
SRP and placeboAlso: Group 1Placement of placebo gel into classII furcation defects after scaling and root planing	Drug	SRP and placebo
SRP and 1% metforminAlso: Group 2Placement of 1% metformin gel into classII furcation defects after scaling and root planing	Drug	SRP and 1% metformin

Primary outcome

Bone defect fill
Time frame: baseline to 9 months
Assesed in percentage

5 secondary outcomes

modified sulcus bleeding index
Time frame: baseline to 9 months
plaque index
Time frame: baseline to 9 months
pocket probing depth
Time frame: baseline to 9 months
relative vertical clinical attachment level
Time frame: baseline to 9 months
relative horizontal clinical attachment level
Time frame: baseline to 9 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2015.

Related trials for Chronic Periodontitis

Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis

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, MDS principal investigator

GDCRI

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SRP and 1% metformin in people with 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Oct 2015. 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Bone defect fill (time frame: baseline to 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02580331.

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 20 Oct 2015.