Skip to main content
OpenTrials
Completed

NCT Number: NCT03204071

Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis

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 favorable effect on alveolar bone.

AloeVera Gel had also been used in dentistry and showed good results.The present study aims to explore the efficacy of 1% MF gel and aloe vera gel as a local drug delivery system in adjunct to scaling and root planing (SRP) for the treatment of subjects with chronic periodontitis (CP) with intrabody defects.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Aim: To compare the efficacy of locally delivered 1% MF gel and aloe vera gel in treatment of intrabony defects in chronic periodontitis subjects and compare it with placebo gel.

Methods: Ninety subjects were categorized into three treatment groups: Placebo, aloevera gel(AV) and 1% Metformin (MF)after Scaling and root planning (SRP). Clinical parameters were recorded at baseline, 6 and 12 months; they included plaque index (PI), modified sulcus bleeding index (mSBI), pocket probing depth (PPD), and clinical attachment level (CAL). Radiologic assessment of intra-bony defect (IBD) and percentage defect depth reduction (DDR%) was done at baseline, 6 months and 12 months interval using computer-aided software Results: Mean PPD reduction and mean CAL gain was found to greater in MF group than AV and placebo group at all visits. The DDR% was greater in MF group as compared to AV and placebo group.

Conclusion: There was a greater decrease in mSBI and PPD and more CAL gain at the sites treated with AV and MF as an adjunct to SRP in chronic periodontitis subjects with intrabony defects as compared to placebo. The significant IBD depth reduction effect was seen in case of MFgroup.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Systemically healthy patients with sites showing PPD ≥ 5 mm, CAL ≥ 4 mm and vertical bone loss ≥ 3 mm on intraoral periapical radiographs, with no history of periodontal therapy in the last 6 months.

-

Exclusion criteria

  • Subjects allergic to MF or AV Those on systemic MF or AV therapy Subjects with aggressive periodontitis Immunocompromised subjects Use of tobacco in any form, alcoholics Lactating, and pregnant females

Treatment and study plan

Placebo Gel

Drug

Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.

Other names: inactive drug

Aloevera

Drug

Oral prophylaxis followed by placement of aloevera gel

Other names: AV

metformin

Drug

Oral prophylaxis followed by placement of metformin gel

Other names: MF

Primary outcomes

  1. Change in Bone defect fill

    Time frame: baseline - 6 months & baseline -12 months

    Assessed in percentage

Secondary outcomes

  1. Change in modified sulcus bleeding index

    Time frame: baseline, 6 & 12 months

    scale 0-3

  2. Change in Plaque index

    Time frame: baseline, 6 & 12 months

    scale 0-3

  3. Change in pocket probing depth

    Time frame: baseline, 6 & 12 months

    measured in mm

  4. Clinical attachment level

    Time frame: baseline, 6 & 12 months

    measured in mm

Sponsors and collaborators

Lead sponsor

Government Dental College and Research Institute, Bangalore

Other

Registry information

Official study title

COMPARATIVE EVALUATION OF SUBGINGIVALLY DELIVERED 1% METFORMIN AND ALOE VERA GEL IN TREATMENT OF INTRABODY DEFECTS IN CHRONIC PERIODONTITIS SUBJECTS: A RANDOMIZED CONTROLLED CLINICAL TRIAL

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 29, 2017
Registry last updated
Jun 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.