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

NCT ID: NCT03204071

Last Updated: 2017-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Group 1

Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.

Group Type PLACEBO_COMPARATOR

placebo gel

Intervention Type DRUG

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

Group 2

Aloe vera gel to be delivered at baseline, 6 and 12 months.

Group Type ACTIVE_COMPARATOR

Aloevera

Intervention Type DRUG

Oral prophylaxis followed by placement of aloevera gel

Group 3

1% metformin gel to be delivered at baseline, 6 and 12 months.

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

Oral prophylaxis followed by placement of metformin gel

Interventions

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placebo gel

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

Intervention Type DRUG

Aloevera

Oral prophylaxis followed by placement of aloevera gel

Intervention Type DRUG

Metformin

Oral prophylaxis followed by placement of metformin gel

Intervention Type DRUG

Other Intervention Names

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inactive drug AV MF

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Government Dental College and Research Institute, Bangalore

OTHER

Sponsor Role lead

Responsible Party

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Dr. A R Pradeep

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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GDCRI/ACM/PG/PhD/2/2015-2016IG

Identifier Type: -

Identifier Source: org_study_id