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

Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sticky Bone; iPRF; Periodontal Defect
• Intervention / Treatment: Biological: Sticky Bone and Repeated Injectable PRF (iPRF); Biological: bone substitute

• Study Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Al Azhar University University; Phone Number: 0020222628346; Email: Azhar@azhar.eun.eg
• Study Contact Backup: Name: mahmoud eldestawy, associted profissor; Phone Number: 00201225864104; Email: mahmoudeldestawy.209@azhar.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 20
    • Mah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 48 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Biological: 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.
Active Comparator: 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.	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in clinical attachment level	change in clinical attachment level	baseline, 3, and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in interseptal bone width	change in interseptal bone width	baseline, 3, and 6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: mahmoud eldestawy, associted profissor, Al Azhar Universty

Study record dates

Study Major Dates

• Study Start (Anticipated): April 16, 2022
• Primary Completion (Anticipated): August 25, 2022
• Study Completion (Anticipated): November 22, 2022

Study Registration Dates

• First Submitted: January 12, 2022
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2022
• Last Update Submitted That Met QC Criteria: March 6, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: iPRF; sticky bone graft
• Other Study ID Numbers: 748/2757

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No