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

Sponsor
Al-Azhar University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05211362
Collaborator
(none)
32
1
2
7.2
4.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Sticky Bone and Repeated Injectable PRF (iPRF)
  • Biological: bone substitute
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Sticky Bone and Repeated Injectable PRF Application in Management of Periodontal Intrabony Defects (Randomized Clinical Trial)
Anticipated Study Start Date :
Apr 16, 2022
Anticipated Primary Completion Date :
Aug 25, 2022
Anticipated Study Completion Date :
Nov 22, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. change in clinical attachment level [baseline, 3, and 6 months]

    change in clinical attachment level

Secondary Outcome Measures

  1. change in interseptal bone width [baseline, 3, and 6 months]

    change in interseptal bone width

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 48 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mah Cairo Egypt 20

Sponsors and Collaborators

  • Al-Azhar University

Investigators

  • Principal Investigator: mahmoud eldestawy, associted profissor, al azhar universty

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
mahmoud eldestawy, associate professor, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT05211362
Other Study ID Numbers:
  • 748/2757
First Posted:
Jan 27, 2022
Last Update Posted:
Mar 8, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by mahmoud eldestawy, associate professor, Al-Azhar University

Study Results

No Results Posted as of Mar 8, 2022