A Phase 2/3 interventional study of placebo gel and Aloevera in Chronic Periodontitis, sponsored by Government Dental College and Research Institute, Bangalore. Completed. Open to participants aged 25 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-29.
Sponsored by Government Dental College and Research Institute, Bangalore · Phase 2/3, Interventional, and Treatment
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.
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.
377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.
This study's enrollment of 90 is above the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.
Browse Chronic Periodontitis studies →Government Dental College and Research Institute, Bangalore is the lead sponsor of 38 studies on the registry; none are open to participants now.
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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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo gel without active ingredient to be delivered at baseline, 6 and 12 months.
Drug: placebo gel
Aloe vera gel to be delivered at baseline, 6 and 12 months.
Drug: Aloevera
1% metformin gel to be delivered at baseline, 6 and 12 months.
Drug: Metformin
Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
Also known as: inactive drug
Oral prophylaxis followed by placement of aloevera gel
Also known as: AV
Oral prophylaxis followed by placement of metformin gel
Also known as: MF
Change in Bone defect fill
Assessed in percentage
Time frame: baseline - 6 months & baseline -12 months
Change in modified sulcus bleeding index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in Plaque index
scale 0-3
Time frame: baseline, 6 & 12 months
Change in pocket probing depth
measured in mm
Time frame: baseline, 6 & 12 months
Clinical attachment level
measured in mm
Time frame: baseline, 6 & 12 months
No study locations are listed for this record.
This study is completed, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Metformin
Government Dental College and Research Institute, Bangalore