Alendronate Compared to Metformin in Chronic Periodontitis

NCT02461667 | Completed Phase 2 DMC

• 1 other identifier: GDCRI/ACM/PG/PhD/2/2013-2014G
• Study Type: interventional
• Target: 108
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a 9 month randomised controlled clinical comparing the clinical efficacy of 1%metformin and 1%alendronate in chronic periodontitis subjects.

Conditions

Chronic Periodontitis

Keywords

alendronate, metformin

Outcome Measures

Primary Outcomes (1)

• bone fill

  amount of bone fill from baseline to 9 months

  baseline to 9 months

Secondary Outcomes (2)

• Relative vertical clinical attachment level

  baseline to 9 months

• probing depth

  baseline to 9 months

Study Arms (3)

placebo

PLACEBO COMPARATOR

SRP plus placebo SRP was done for all the subjects. Placebo gel was delivered subgingivally into the pocket

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

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

Drug: SRP plus Alendronate gel

Interventions

SRP plus Placebo Gel DRUG

After SRP, placebo gel was delivered subgingivally into the pocket

Also known as: Placebo

placebo

SRP plus Alendronate gel DRUG

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

Also known as: Alendronate gel

Alendronate

SRP plus Metformin gel DRUG

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

Also known as: Metformin gel

Metformin

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Government Dental College and Research Institute, Bangalore: lead

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and head, Dept. of Periodontology

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: June 3, 2015
• Study Start: July 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 3, 2015

Record last verified: 2015-05