Chronic PeriodontitisPhase 2/3NCT02461667
Alendronate Compared to Metformin in Chronic Periodontitis
A Phase 2/3 study testing SRP plus Alendronate gel and SRP plus Metformin gel in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
Trial summary
This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- SRP plus Alendronate gel and SRP plus Metformin gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Mar 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 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- All the subjects were systemically healthy
- subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
- vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
- subjects with no history of periodontal intervention in the last 6 months.
Who cannot join
- patients with systemic diseases like cardiovascular disease
- diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- pregnant/lactating females
- tobacco users
- alcoholics
- patients with unsatisfactory oral hygiene (plaque index greater than 1.5)
- teeth having gingival recession, caries involving pulp, intrabony defect present interproximally, grade 2/3 mobility
- Furthermore, patients allergic to Metformin and alendronate or those taking Metformin and alendronate systemically were excluded.
About this study
Official title: Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.
Read the detailed description
ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods:
The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months
- Conditions
- Chronic Periodontitis
- Being tested
- SRP plus Placebo Gel, SRP plus Alendronate gel, SRP plus Metformin gel
- Keywords
- alendronate, 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 plus Placebo GelDrug
Also called Placebo
After SRP, placebo gel was delivered subgingivally into the pocket
SRP plus Alendronate gelDrug
Also called Alendronate gel
Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket
SRP plus Metformin gelDrug
Also called Metformin gel
Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket Receives: Drug: SRP plus Placebo Gel |
| Metformin | Active comparator | SRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally Receives: Drug: SRP plus Metformin gel |
| Alendronate | Active comparator | SRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally Receives: Drug: SRP plus Alendronate gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone fill
amount of bone fill from baseline to 9 months
Measured: baseline to 9 months
Secondary outcomes (2)
Relative vertical clinical attachment level
change in Relative vertical clinical attachment level baseline to 9 months
Measured: baseline to 9 months
probing depth
change in probing depth from baseline to 9 months
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.
- First posted3 Jun 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015
- Study completionMar 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 108 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02461667
- Sponsor's protocol ID
- GDCRI/ACM/PG/PhD/2/2013-2014G
- Status last verified
- May 2015
- First submitted
- 19 May 2015
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02461667
- Acronym / sponsor ID
- GDCRI/ACM/PG/PhD/2/2013-2014G
- Conditions
- Chronic Periodontitis
- Keywords
- alendronate, metformin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Government Dental College and Research Institute, BangaloreUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 3 Jun 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.
This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.
Detailed description
ABSTRACT Background: Since Metformin (MF) induces osteoblast growth and differentiation while Alendronate (ALN) act as an antiosteolytic agent. The aim of the present study is to evaluate and compare the efficacy of 1% ALN and 1% MF gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of intrabony defects in patients with chronic periodontitis.
Methods:
The study had 3 groups comprising of ninety subjects, divided into three groups 1% MF with SRP, 1% ALN with SRP and placebo gel with SRP. Clinical parameters (plaque index (PI), modified sulcus bleeding index (mSBI), probing pocket depth (PPD), and clinical attachment level (CAL) were recorded at baseline, 3, 6 and 9 months. Radiographic parameters intrabony defect depth (IBD) and defect depth reduction (DDR%) was calculated on standardized radiographs by using image analysis software at 6 and 9 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: SRP plus Placebo GelSRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket |
| Metformin | Active comparator | Drug: SRP plus Metformin gelSRP plus Metformin SRP was done for all the subjects. metformin was delivered in the pocket subgingivally |
| Alendronate | Active comparator | Drug: SRP plus Alendronate gelSRP plus Alendronate SRP was done for all the subjects. Alendronate was delivered in the pocket subgingivally |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All the subjects were systemically healthy
- subjects with sites having CAL ≥ 3 mm, PPD ≥ 5 mm,
- vertical bone loss ≥ 3 mm on intraoral periapical radiographs (IOPA) and
- subjects with no history of periodontal intervention in the last 6 months.
Key exclusion criteria (8 listed)
- patients with systemic diseases like cardiovascular disease
- diabetes or HIV infection or on medications like corticosteroids which may impede the healing in periodontal tissues.
- pregnant/lactating females
- tobacco users
- alcoholics
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 plus Placebo GelAlso: PlaceboAfter SRP, placebo gel was delivered subgingivally into the pocket | Drug | placebo |
| SRP plus Alendronate gelAlso: Alendronate gelAlendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket | Drug | Alendronate |
| SRP plus Metformin gelAlso: Metformin gelMetformin (MF) After SRP, MF gel was delivered subgingivally into the pocket | Drug | Metformin |
Primary outcome
bone fill
Time frame: baseline to 9 months
amount of bone fill from baseline to 9 months
2 secondary outcomes
Relative vertical clinical attachment level
Time frame: baseline to 9 months
probing depth
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 3 Jun 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing SRP plus Alendronate gel and SRP plus Metformin gel in people with Chronic Periodontitis, run by Government Dental College and Research Institute, Bangalore.
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 8 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 3 Jun 2015. 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. 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 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?
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 Jun 2015.