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

NCT05211362 | Unknown Phase 4

• 1 other identifier: 748/2757
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Sticky Bone; iPRF; Periodontal Defect

Keywords

iPRF; sticky bone graft

Outcome Measures

Primary Outcomes (1)

• change in clinical attachment level

  change in clinical attachment level

  baseline, 3, and 6 months

Secondary Outcomes (1)

• change in interseptal bone width

  baseline, 3, and 6 months

Study Arms (2)

Sticky Bone and Repeated Injectable PRF (iPRF)

EXPERIMENTAL

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)

bone substitute

ACTIVE COMPARATOR

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

Interventions

Sticky Bone and Repeated Injectable PRF (iPRF) BIOLOGICAL

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.

Sticky Bone and Repeated Injectable PRF (iPRF)

bone substitute BIOLOGICAL

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.

bone substitute

Eligibility Criteria

• Age: 18 Years - 48 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant females.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Mah

Cairo, 20, Egypt

Location

MeSH Terms

Interventions

Bone Substitutes

Intervention Hierarchy (Ancestors)

Biocompatible Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• mahmoud eldestawy, associted profissor

  al azhar universty

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Al Azhar University University

CONTACT

0020222628346; Azhar@azhar.eun.eg

mahmoud eldestawy, associted profissor

CONTACT

00201225864104; mahmoudeldestawy.209@azhar.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: January 27, 2022
• Study Start: April 16, 2022
• Primary Completion: August 25, 2022
• Study Completion: November 22, 2022
• Last Updated: March 8, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)