Chronic Periodontitis
Conditions
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.
Interventions
DRUGplacebo gel
Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
DRUGAloevera
Oral prophylaxis followed by placement of aloevera gel
DRUGMetformin
Oral prophylaxis followed by placement of metformin gel
Sponsors
Government Dental College and Research Institute, Bangalore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Bone defect fill | baseline - 6 months & baseline -12 months | Assessed in percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in modified sulcus bleeding index | baseline, 6 & 12 months | scale 0-3 |
| Change in Plaque index | baseline, 6 & 12 months | scale 0-3 |
| Change in pocket probing depth | baseline, 6 & 12 months | measured in mm |
| Clinical attachment level | baseline, 6 & 12 months | measured in mm |
Outcome results
None listed