Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects

NCT06641739 | Not Yet Recruiting

• 1 other identifier: laser and PRF in periodontitis
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Stage 3 periodontitis is a condition marked by swift and severe destruction of periodontal tissues. To effectively regenerate osseous defects resulting from periodontal disease, it is crucial to leverage the intrinsic regenerative potential of the periodontium via meticulously formulated therapeutic strategies

Conditions

Periodontal Diseases

Keywords

photobiomodulation; laser therapy; PRF; stage III periodontal diseases

Outcome Measures

Primary Outcomes (2)

• -Evaluation of the changes in the clinical attachment loss

  Attachment level will be measured using UNC15(University of North Carolina) periodontal probe. Clinical attachment loss will be measured as the distance from the cemento-enamel junction to the base of the pocket.\[Time Frame: at base line, 1 month and 3 months after treatment\]

  [Time Frame: at base line, 1 month and 3 months after treatment]

• probing depth

  The measurement will be recorded by UNC15(University of North Carolina) periodontal probe . Pocket depth will be measured as the distances from the free gingival margin to the base of the periodontal pocket.

  [Time Frame: at base line, 1 month and 3 months after treatment]

Secondary Outcomes (2)

• -Plaque index (PI)

  [Time Frame: at base line, 1 month and 3 months after treatment]

• Gingival index (GI)

  [Time Frame: at base line, 1 month and 3 months after treatment]

Study Arms (2)

• Laser-treated group

ACTIVE COMPARATOR

Ten patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers ( 940nm), with an output power of 3 W in the contact mode.

Device: laser assisted SPPF

platelets Rich Fibrin Graft

ACTIVE COMPARATOR

Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site.

Procedure: Platelet Rich Plasma

Interventions

laser assisted SPPF DEVICE

A full-thickness flaps were elevated. In the test sites after the SPPF access will be performed, root surface debridement will be meticulously performed, followed by intra-marrow penetrations (IMPs), on the defect walls using a 0.25 mm wide half round bur, mounted on a slow-speed handpiece. Following this, low-level laser biostimulation of the defect will be effected with an 940 nm diode laser at 3 W power, with an uninitiated 0.6mm optical fiber tip. The defects will be irradiated for 20 seconds in a continuous noncontact mode and then retracted for 8 seconds. This will be repeated for 3 times so that the defects were effectively lased for about 60 seconds.

• Laser-treated group

Platelet Rich Plasma PROCEDURE

In the second group, following the SPPF, the defect will grafted with particulated PRF, which will be overlaid with a PRF membrane, without any adjunctive defect management measures. PRF will be prepared by collecting Intra-venous blood (from the antecubital vein) in a 10-ml sterile glass tube without anticoagulant and immediately centrifuged in a centrifugation machine at 3000 rpm for 10 minutes. It will result in the separation of blood into a structured fibrin matrix in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma (platelet poor plasma) at the top. PPP will be discarded. PRF will be easily separated from the red corpuscles base using sterile tweezers and scissors.

platelets Rich Fibrin Graft

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with PPD =5 mm and clinical attachment loss of ≥3 mm;
• Presence of 2 walled or 3 walled infra-bony defects posterior segments;
• Evidence of ≥3 mm of intra-bony defect depth evaluated by the visualization of peri-apical radiographs.

You may not qualify if:

• Patients requiring antibiotic prophylaxis before the periodontal examination;
• Patients diagnosed with malocclusion at the site of the defect;
• Patients with systemic disease and/or on drugs that contraindicate periodontal surgery;
• Patients with a history of smoking and pan chewing;
• Sites with advanced class II \& III furcation involvement.

Sponsors & Collaborators

• Assiut University: lead

Related Links

• reatment of 3-wall intrabony defects in patients with chronic periodontitis with autologous platelet-rich fibrin: A randomized controlled clinical trial. J
• Clinical significance of non-surgical periodontal therapy: an evidence-based perspective of scaling and root planing
• Regeneration of periodontal intrabony defects using platelet-rich fibrin (PRF): A systematic review and network meta-analysis. Odontology
• Strategies of cell and cell-free therapies for periodontal regeneration: the state of the art.

MeSH Terms

Conditions

Periodontal Diseases

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ahmed Mortada Fikry, professor

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nashwa Helaly Mohamed, lecturer

CONTACT

+2001002226405; nashwahelaly@aun.edu.eg

AlAlzahraa Ahmed Ibrahim Alghriany, lecturer

CONTACT

+201203770058; alghriany@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Group 1: Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site. Group 2: Ten patients will be treated the simplified papilla preservation flap with laser therapy performed into the defect site. The laser used in the study is diode lasers (940nm), with an output power of 3 W in the contact mode.

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: October 15, 2024
• Study Start: October 15, 2024
• Primary Completion: January 1, 2025
• Study Completion: February 5, 2025
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share