Comparative evaluation of Amniotic membrane/Collagen membrane for the management of periodontal intra-bony defects

Not yet recruiting

• Conditions: Chronic periodontitis,

• Registration Number: CTRI/2020/03/024075
• Lead Sponsor: nivedhav

Brief Summary

This study is a prospective double blind, randomised, parallel group clinical trial comparing the clinical and radiological parameters following the use of biphasic alloplastic material with amniotic membrane/ collagen membrane for the management of periodontal intrabony defects. The primary outcomes will be to assess the change in probing pocket depth/ clinical attachment level and radiographic bone gain at 1, 3 and 6 months, secondary outcomes will be assess the wound healing index, visual analogue scale at 3 and 10 days post operatively.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-17
• Study Start: 2020-03-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 1 Age 21-50 years 2 Patients with moderate to severe localized periodontitis with a Probing Depth (PD) ≥6 mm and an intrabony component of more than 3 mm as detected on Intra oral periapical radiographs (IOPAR) and bone sounding (Sali 2016).
• 3 Intrabony defect angle of less than 40 degree (Sali 2016).
• 4 Circumferential defect with interdental intrabony defect depth of more than 3mm will be included.
• 5 Nonsmoker (Never smoker) or former smoker (Does not smoke now and has not smoked at all for a minimum of the last 12 consecutive months).

Exclusion Criteria

1 Current Smokers (smokers who have smoked more than 100 cigarettes in their lifetime and currently smoke) 2 Systemic chronic conditions known to be associated with periodontitis or with changes in systemic inflammation: Diabetes, Cardiovascular diseases, Rheumatoid Arthritis, Rheumatic Fever, SLE, Malignancy, Respiratory diseases, Renal diseases, Other (e.g., autoimmune diseases, fungal infections, immunological deficiencies, etc.) 3 Pregnant / Lactating mothers 4 Previous History of periodontal treatment at the selected site 5 Teeth with intrabony defect component and furcation involvement were also excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Probing Pocket Depth or Clinical Attachment Level and Radiographic bone gain	baseline, 1 month, 3 month and 6 month

Secondary Outcome Measures

Name	Time	Method
Wound Healing index, Visual Analogue Scale	at 3, 10 days

Trial Locations

Locations (1)

sri ramachandra institute of higher education and research; 🇮🇳 Chennai, TAMIL NADU, India

sri ramachandra institute of higher education and research

🇮🇳Chennai, TAMIL NADU, India

NivedhaV

Principal investigator

9445513282

nive16roro@gmail.com