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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
Sponsor:
Information provided by (Responsible Party):
Dr. A R Pradeep, Government Dental College and Research Institute, Bangalore

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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: placebo gel Drug: Aloevera Drug: Metformin Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Aloevera
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.
Drug: Metformin
Oral prophylaxis followed by placement of metformin gel
Other Name: MF




Primary Outcome Measures :
  1. Change in Bone defect fill [ Time Frame: baseline - 6 months & baseline -12 months ]
    Assessed in percentage


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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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

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Responsible Party: Dr. A R Pradeep, professor, Government Dental College and Research Institute, Bangalore
ClinicalTrials.gov Identifier: NCT03204071     History of Changes
Other Study ID Numbers: GDCRI/ACM/PG/PhD/2/2015-2016IG
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: June 29, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs