Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
Primary Purpose
Chronic Periodontitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
placebo gel
Aloevera
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Periodontitis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group 1
Group 2
Group 3
Arm Description
Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
Aloe vera gel to be delivered at baseline, 6 and 12 months.
1% metformin gel to be delivered at baseline, 6 and 12 months.
Outcomes
Primary Outcome Measures
Change in Bone defect fill
Assessed in percentage
Secondary Outcome Measures
Change in modified sulcus bleeding index
scale 0-3
Change in Plaque index
scale 0-3
Change in pocket probing depth
measured in mm
Clinical attachment level
measured in mm
Full Information
NCT ID
NCT03204071
First Posted
June 28, 2017
Last Updated
June 28, 2017
Sponsor
Government Dental College and Research Institute, Bangalore
1. Study Identification
Unique Protocol Identification Number
NCT03204071
Brief Title
Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Government Dental College and Research Institute, Bangalore
4. Oversight
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1
Arm Type
Placebo Comparator
Arm Description
Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
Arm Title
Group 2
Arm Type
Active Comparator
Arm Description
Aloe vera gel to be delivered at baseline, 6 and 12 months.
Arm Title
Group 3
Arm Type
Active Comparator
Arm Description
1% metformin gel to be delivered at baseline, 6 and 12 months.
Intervention Type
Drug
Intervention Name(s)
placebo gel
Other Intervention Name(s)
inactive drug
Intervention Description
Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
Intervention Type
Drug
Intervention Name(s)
Aloevera
Other Intervention Name(s)
AV
Intervention Description
Oral prophylaxis followed by placement of aloevera gel
Intervention Type
Drug
Intervention Name(s)
Metformin
Other Intervention Name(s)
MF
Intervention Description
Oral prophylaxis followed by placement of metformin gel
Primary Outcome Measure Information:
Title
Change in Bone defect fill
Description
Assessed in percentage
Time Frame
baseline - 6 months & baseline -12 months
Secondary Outcome Measure Information:
Title
Change in modified sulcus bleeding index
Description
scale 0-3
Time Frame
baseline, 6 & 12 months
Title
Change in Plaque index
Description
scale 0-3
Time Frame
baseline, 6 & 12 months
Title
Change in pocket probing depth
Description
measured in mm
Time Frame
baseline, 6 & 12 months
Title
Clinical attachment level
Description
measured in mm
Time Frame
baseline, 6 & 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Locally Delivered Metformin and Aloe Vera for Treatment of Intrabody Defects in Chronic Periodontitis
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