Local Host Modulating Agents Alendronate & Aloe Vera for Treatment of Furcation Defects in Chronic Periodontitis

Chronic Periodontitis Clinical Trial

Official title:

1% Alendronate and Aloevera Gel Local Host Modulating Agents in Chronic Periodontitis Subjects With Class II Furcation Defects: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03204097
• Other study ID #: GDCRI/ACM/PG/PhD/2/2015-2016IP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 28, 2017
• Last updated: June 28, 2017
• Start date: March 2016
• Est. completion date: February 2017

Study information

• Verified date: June 2017
• Source: Government Dental College and Research Institute, Bangalore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Periodontitis
• Furcation Defects
• Periodontitis

Intervention

Drug:
• placebo
Oral prophylaxis followed by placement of placebo gel
• Alendronate
Oral prophylaxis followed by placement of Alendronate gel
• Aloe Vera
Oral prophylaxis followed by placement of Aloe Vera gel

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Government Dental College and Research Institute, Bangalore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bone defect depth	Assessed in percentage	baseline, 6 & 12 months
Secondary	Change in modified sulcus bleeding index	scale 0-3	baseline, 6 & 12 months
Secondary	Change in Plaque index	scale 0-3	baseline, 6 & 12 months
Secondary	Change in pocket probing depth	measured in mm	baseline, 6 & 12 months
Secondary	Change in relative vertical clinical attachment level	measured in mm	baseline, 6 & 12 months
Secondary	Change in relative horizontal clinical attachment level	measured in mm	baseline, 6 & 12 months