Sticky Bone and Repeated Injectable PRF (iPRF) Application in Management of Periodontal Intrabony Defects

Phase 4

• Conditions: Sticky Bone; iPRF; Periodontal Defect
• Interventions: Biological: bone substitute; Biological: Sticky Bone and Repeated Injectable PRF (iPRF)

• Registration Number: NCT05211362
• Lead Sponsor: Al-Azhar University

Brief Summary

One of the main objectives of periodontal therapy is the regeneration of the tooth's supporting periodontal tissue to its original levels. The healing after non-surgical and conventional surgical methods is histologically characterized by a long junctional epithelium along the root surfaces. Therefore, reconstructive techniques are required. Although complete periodontal regeneration is unpredictable with any regenerative therapy currently used, so the objective of our trial is to get complete periodontal regeneration by using Sticky Bone and Repeated Injectable PRF (iPRF) in Management of Periodontal Intrabony Defects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-01-12
• Study First Posted: 2022-01-27
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-06
• Last Update Posted: 2022-03-08
• Study Start: 2022-04-16
• Primary Completion: 2022-08-25
• Study Completion: 2022-11-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• No systemic diseases which could influence the outcome of therapy.
• Good compliance with plaque control instructions following initial therapy.
• Teeth involved were all vital with no mobility.
• Each subject contributed a single predominately 2 or 3-wall intrabony interproximal defect around premolar or molar teeth without furcation involvement
• Selected intrabony defects (IBD) measured from the alveolar crest to the defect base in diagnostic periapical radiographs of ≥ 3 mm, the width of ≥ 3 mm at its most coronal part, with no cratering that involve both mesial and distal surfaces of adjacent teeth.
• Selected probing depth (PD) ≥ 6 mm and clinical attachment loss (CAL) ≥ 4 mm at the site of intraosseous defects four weeks following initial cause-related therapy.
• Availability for the follow-up and maintenance program; 8) absence of periodontal treatment during the previous year.

Exclusion Criteria

• Pregnant females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
bone substitute	bone substitute	The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, bone graft substitute was heavily condensed into the intra bony defects. The flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.
Sticky Bone and Repeated Injectable PRF (iPRF)	Sticky Bone and Repeated Injectable PRF (iPRF)	The surgical treatment phase was initiated only if the subjects had a full-mouth dental plaque score of less than one and a test site plaque score of 0. Following mucoperiosteal flap reflection for one tooth on either side of the defect, all granulation tissue was removed from the defects by means of Gracey 7/8 metal curettes, and root surfaces were scaled and planed using hand and ultrasonic instruments, then the defect was filled with xenograft mixed with IPRF, Finally, the flap was replaced and closed with crossed horizontal and vertical internal mattress sutures.

Primary Outcome Measures

Name	Time	Method
change in clinical attachment level	baseline, 3, and 6 months	change in clinical attachment level

Secondary Outcome Measures

Name	Time	Method
change in interseptal bone width	baseline, 3, and 6 months	change in interseptal bone width

Trial Locations

Locations (1)

Mah; 🇪🇬 Cairo, Egypt