A Phase 2/3 interventional study of placebo and Alendronate 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
Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects
Alendronate (ALN), commonly use bisphosphonates is proposed to have osteostimulative properties in vivo and in vitro, as shown by an increase in the matrix formation, and acts as a potent inhibitor of bone resorption. AV widely known for its wound healing, analgesic, antioxidant, antibacterial, antiviral, antifungal, immune boosting and significant anti-inflammatory properties. The present study aims to explore the efficacy of 1% ALN and AV gel as a local drug delivery as an adjunct to scaling and root planing (SRP) for the treatment of degree II furcation defects.
Methods: Ninety patients with mandibular buccal class II furcation defects were randomly allocated into three treatment groups: SRP plus placebo gel (group 1), SRP plus 1% ALN gel (group 2) and SRP plus AV gel (group3). Clinical and radiographic parameters were recorded at baseline and gel were delivered at respective site. Then again all clinical and radiographic parameters were recorded after 6 and 12 months from baseline.
Inclusion Criteria:Systemically healthy patients with mandibular class II furcation defects and asymptomatic endodontically vital mandibular molars with radiolucency in furcation area with PD ≥ 5mm and horizontal PD ≥ 3mm and with no history of antibiotic or any periodontal therapy in past 6 months were included in the study -
Exclusion Criteria:Subjects with any known systemic disease, allergic to alendronate or aloe vera, on systemic alendronate therapy, alcoholics, tobacco users, pregnant or lactating women
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Scaling and root planing (SRP) followed by placebo gel local drug delivery
Drug: placebo
SRP followed by 1% Alendronate (ALN) gel
Drug: Alendronate
SRP followed by Aloevera (AV) gel
Drug: Aloe Vera
Oral prophylaxis followed by placement of placebo gel
Also known as: inactive drug
Oral prophylaxis followed by placement of Alendronate gel
Also known as: ALN
Oral prophylaxis followed by placement of Aloe Vera gel
Also known as: AV
Change in Bone defect depth
Assessed in percentage
Time frame: baseline, 6 & 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
Change in relative vertical clinical attachment level
measured in mm
Time frame: baseline, 6 & 12 months
Change in relative horizontal clinical attachment level
measured in mm
Time frame: baseline, 6 & 12 months
No study locations are listed for this record.
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Government Dental College and Research Institute, Bangalore