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Alendronate Compared to Metformin in Chronic Periodontitis

Comparative Evaluation of Subgingivally Delivered 1% Metformin and 1% Alendronate Gel in Treatment of Chronic Periodontitis: a Randomized Placebo Controlled Clinical Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02461667
Enrollment
108
Registered
2015-06-03
Start date
2014-07-31
Completion date
2015-03-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Periodontitis

Keywords

alendronate, metformin

Brief summary

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

Interventions

After SRP, placebo gel was delivered subgingivally into the pocket

DRUGSRP plus Alendronate gel

Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket

DRUGSRP plus Metformin gel

Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket

Sponsors

Government Dental College and Research Institute, Bangalore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
bone fillbaseline to 9 monthsamount of bone fill from baseline to 9 months

Secondary

MeasureTime frameDescription
Relative vertical clinical attachment levelbaseline to 9 monthschange in Relative vertical clinical attachment level baseline to 9 months
probing depthbaseline to 9 monthschange in probing depth from baseline to 9 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026