A clinical trial to compare the efficacy of thorough cleaning with placement of PepGen P-15 a bone graft and thorough cleaning alone in treatment of periodontitis patients, clinically and radiographically.

Phase 1/2

Active, not recruiting

• Conditions: Chronic Periodontitis Patients

• Registration Number: CTRI/2017/11/010669

Brief Summary

This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of Open Flap Debridement (OFD)  with placement of PepGen P-15 and OFD alone in 20 patients with chronic periodontitis exhibiting bilateral periodontal infrabony defects (20 sites for each group)  followed by re-evaluation at 3 and  6 months.

The primary outcome measures will be improvement in patient’s periodontal status (reduced probing pocket depth, gain in clinical attachment level, and bone fill at periodontal defects.

The secondary outcomes will be reduction in patient’s plaque & gingival bleeding scores.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-19
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Presence of at least 2 radiographically detectable interproximal osseous defects with a probing depth ≥5mm & clinical attachment loss ≥ 5mm following initial therapy.
• The depth of the intraosseous component of the defect estimated as ≥3mm by clinical and radiographic means.

Exclusion Criteria

• Subjects with history of systemic diseases, allergies or drug usage.
• Subjects who have undergone periodontal treatment in previous 6 months 3.
• Teeth exceeding class II mobility.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcomes: Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in Periodontal Infrabony Defect (seen radiographically)	outcome will be assessed at 3 months and 6 months.

Secondary Outcome Measures

Name	Time	Method
Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status	At 6 months

Trial Locations

Locations (1)

V.S.P.M Dental College & Research Centre; 🇮🇳 Nagpur, MAHARASHTRA, India

V.S.P.M Dental College & Research Centre

🇮🇳Nagpur, MAHARASHTRA, India

Dr Pratima Mishra

Principal investigator

07387082084

dr.pratima.mishra.31@gmail.com