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

A

Al-Azhar University

Status and phase

Unknown
Phase 4

Conditions

iPRF
Periodontal Defect
Sticky Bone

Treatments

Biological: bone substitute
Biological: Sticky Bone and Repeated Injectable PRF (iPRF)

Study type

Interventional

Funder types

Other

Identifiers

NCT05211362
748/2757

Details and patient eligibility

About

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.

Enrollment

32 estimated patients

Sex

All

Ages

18 to 48 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups

Sticky Bone and Repeated Injectable PRF (iPRF)
Experimental group
Description:
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.
Treatment:
Biological: Sticky Bone and Repeated Injectable PRF (iPRF)
bone substitute
Active Comparator group
Description:
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.
Treatment:
Biological: bone substitute

Trial contacts and locations

1

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Central trial contact

mahmoud eldestawy, associted profissor; Al Azhar University University

Data sourced from clinicaltrials.gov

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