Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
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|ClinicalTrials.gov Identifier: NCT03204071|
Recruitment Status : Completed
First Posted : June 29, 2017
Last Update Posted : June 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Periodontitis||Drug: placebo gel Drug: Aloevera Drug: Metformin||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official 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|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||February 2017|
|Actual Study Completion Date :||February 2017|
Placebo Comparator: Group 1
Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
Drug: placebo gel
Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
Other Name: inactive drug
Active Comparator: Group 2
Aloe vera gel to be delivered at baseline, 6 and 12 months.
Oral prophylaxis followed by placement of aloevera gel
Other Name: AV
Active Comparator: Group 3
1% metformin gel to be delivered at baseline, 6 and 12 months.
Oral prophylaxis followed by placement of metformin gel
Other Name: MF
- Change in Bone defect fill [ Time Frame: baseline - 6 months & baseline -12 months ]Assessed in percentage
- Change in modified sulcus bleeding index [ Time Frame: baseline, 6 & 12 months ]scale 0-3
- Change in Plaque index [ Time Frame: baseline, 6 & 12 months ]scale 0-3
- Change in pocket probing depth [ Time Frame: baseline, 6 & 12 months ]measured in mm
- Clinical attachment level [ Time Frame: baseline, 6 & 12 months ]measured in mm