effect of antilipidemic drug Simvastatin with commercially available bone graft in regeneration of bone loss in chronic periodontal disease

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012740
• Date of registration: 22-03-2018
• Prospective Registration: No
• Primary sponsor: Darshanaa Arunachalam
• Public title: effect of antilipidemic drug Simvastatin with commercially available bone graft in regeneration of bone loss in chronic periodontal disease
• Scientific title: Clinical effect of Simvastatin gel with bone graft in grade II furcation defects - A randomized controlled clinical trial
• Date of first enrolment: 24-02-2017
• Target sample size: 20
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=17973
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: Phase 2/ Phase 3

Countries of recruitment

India

Contacts

• Name: Darshanaa Arunachalam
• Affiliation: Saveetha Dental College

• Name: Sheeja S Varghese
• Affiliation: Saveetha Dental College

Key inclusion & exclusion criteria

Inclusion criteria: 1. Presence of isolated grade II furcation defect

2. No recent history of antibiotic and periodontal therapy


Exclusion criteria: 1. Systemic illness

2. Allergic to SMV

3. Systemic statin therapy

4. Pregnant lactating woman

5. Tobacco users

6. Immunocompromised patients

Alcoholism

Unacceptable oral hygiene



Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Systemically healthy patients with Chronic periodontitis with grade 2 furcation involvements

Intervention(s)

Intervention1: Simvastatin with bone graft: 1.2mg Simvastatin per 1ml 4% methycellulose gel added to commercially available synthetic nanocrystalline hydroxyapatite bone graft
Control Intervention1: Simvastatin gel: 1.2mg Simvastatin per 1ml 4% methycellulose gel
Control Intervention2: Placebo gel: 4% methylcellulose gel
Control Intervention3: Bone graft: commercially available synthetic nanocrystalline hydroxyapatite bone graft
Control Intervention4: Simvastatin: 1.2mg simvastatin per 1ml 4% methycellulose gel

Primary Outcome(s)

Clinical- horizontal probing depth, vertical probing depth, vertical clinical attachment loss

Radiographic- vertical defect depth in IOPA, horizontal defect depth in CBCT, vertical defect depth in CBCT, volume of the defect in CBCTTimepoint: 0, 3, 6 months

Secondary Outcome(s)

full mouth mean plaque index, full mouth mean bleeding index, full mouth mean probing depth, full mouth mean clinical attachment loss, intervention tooth mean plaque index, intervention tooth mean bleeding index, intervention tooth mean probing depth, intervention tooth mean clinical attachment lossTimepoint: 0, 3, 6 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

Saveetha Dental college, 162, Poonamallee high road, Velappanchavadi, Chennai - 600077

Ethics review

Status: Approved
Approval date: 18/04/2016
Contact:

Scientific review board, Saveetha dental college, Saveetha institute of medical and technological sciences

Results

• Date Completed: 19/12/2017