Comparison of Platelet-Rich Fibrin in combination with bone graft and bone graft alone in treatment of periodontal bone loss.

Phase 4

Recruiting

• Conditions: Chronic Periodontitis Patients

• Registration Number: CTRI/2017/02/007796

Brief Summary

This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of glass based alloplastic bone graft material alone and combination of glass based alloplastic bone graft material with autologus Pltelet Rich Fibrin in 20 patients with chronic periodontitis exhibiting at least a pair of intrabony 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 intrabony defects.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-03
• Last Update Posted: 2017-07-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Patients with moderate to advanced periodontitis as assessed by probing pocket depth ≥ 5 mm and clinical attachment level ≥ 5 mm 2.
• Patients with atleast one pair of bilateral periodontal intrabony defect in either maxillary or mandibular arch.

Exclusion Criteria

• Subjects with history of systemic diseases, allergies or drug usage.
• Subjects who have undergone periodontal treatment in previous 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, gain in Clinical Attachment Level, Bone Fill in intrabony defect (seen by advanced radiography i.e. RVG & CBCT) within 3 to 6 months	baseline, 6 weeks, 3 months, 6months

Secondary Outcome Measures

Name	Time	Method
Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status, within 3-6 months.	baseline, 6 weeks, 3 months, 6months

Trial Locations

Locations (1)

VSPM Dental College & Research Centre Nagpur; 🇮🇳 Nagpur, MAHARASHTRA, India

VSPM Dental College & Research Centre Nagpur

🇮🇳Nagpur, MAHARASHTRA, India

DR BODHARE GIRISH HARIPAL

Principal investigator

07709562363

ghb231989@gmail.com