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

NCT ID: NCT05211362

Last Updated: 2022-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-16

Study Completion Date

2022-11-22

Brief Summary

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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

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Conditions

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Sticky Bone iPRF Periodontal Defect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Sticky Bone and Repeated Injectable PRF (iPRF)

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

bone substitute

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

48 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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mahmoud eldestawy

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mahmoud eldestawy, associted profissor

Role: PRINCIPAL_INVESTIGATOR

al azhar universty

Locations

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Mah

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Al Azhar University University

Role: CONTACT

0020222628346

mahmoud eldestawy, associted profissor

Role: CONTACT

00201225864104

Other Identifiers

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748/2757

Identifier Type: -

Identifier Source: org_study_id

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