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

October 11, 2024 updated by: Nashwa Helaly Mohamed, Assiut University

Comparative Clinical Trials of Laser Photobiomodulation and Platelets Rich in Growth Factors (PRGFs)-Assisted Flap Surgery in Treating Stage III Periodontal Defects: an In-Depth Analysis of Clinical Outcomes and Healing Processes

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main treatment methods of periodontal diseases involve scaling and root planning (SRP), and periodontal surgery. Periodontopathogens, can penetrate deep by crossing the epithelial barrier which may be difficult to be remove by nonsurgical periodontal therapy (NSPT) alone. A multitude of grafted and non-grafted approaches have been used in the management of Intra-bony defects. However, they do not provide predictable periodontal regeneration.

A systematic review on the use of platelet-rich fibrin (PRF) for managing periodontal defects highlights its promising potential in periodontal regeneration. It forms a fibrin matrix that promotes angiogenesis and enhances healing at defected sites. The review emphasizes PRF's ability to sustain the release of growth factors, which are crucial for osteoblastic proliferation, migration, and adherence. This makes PRF an effective scaffold for cellular elements, facilitating periodontal tissue regeneration.

Laser photobiomodulation (PBM) has emerged as a promising adjunctive treatment as it stimulates cellular processes, enhancing the natural regenerative capabilities of periodontal tissues. Recent studies have demonstrated that PBM, particularly with diode, significantly improves clinical outcomes when combined with conventional periodontal treatments. It promotes osteoblastic proliferation, migration, and adherence, thereby facilitating bone regeneration and reducing periodontal pocket depth. Additionally, PBM enhances angiogenesis and modulates the release of growth factors, creating an optimal healing environment.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: AlAlzahraa Ahmed Ibrahim Alghriany, lecturer
  • Phone Number: +201203770058
  • Email: alghriany@aun.edu.eg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: • Laser-treated group
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
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.
Active Comparator: platelets Rich Fibrin Graft
Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site.
Procedure: Platelet Rich Plasma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Evaluation of the changes in the clinical attachment loss
Time Frame: [Time Frame: at base line, 1 month and 3 months after treatment]
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
Time Frame: [Time Frame: at base line, 1 month and 3 months after treatment]
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
-Plaque index (PI)
Time Frame: [Time Frame: at base line, 1 month and 3 months after treatment]

It used to assess plaque accumulation around gingival margin.

The degree of plaque accumulation was recorded as follow:

  • 0= No plaque around the gingival margin.
  • 1= A thin film of plaque around the gingival margin. The plaque may be recognized only by running a probe across the tooth surface.
  • 2= Moderate accumulation of soft deposits on the gingival margin and/or adjacent tooth surface, which can be seen by naked eye. 3= Abundance plaque accumulation within the gingival pocket and/or on the gingival margin and adjacent tooth surface and hard deposits on the tooth surface are seen.
[Time Frame: at base line, 1 month and 3 months after treatment]
Gingival index (GI)
Time Frame: [Time Frame: at base line, 1 month and 3 months after treatment]

It used to assess gingival inflammation. The degree of gingival inflammation will be recorded as follow:

  • 0 = Normal gingiva.
  • 1 = Mild inflammation, slight change in color, slight edema and no bleeding on probing.
  • 2= Moderate inflammation, redness, edema and bleeding on probing.
  • 3= Severe inflammation, marked redness, edema and tendency to spontaneous bleeding.
[Time Frame: at base line, 1 month and 3 months after treatment]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Ahmed Mortada Fikry, professor, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 15, 2024

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

February 5, 2025

Study Registration Dates

First Submitted

October 10, 2024

First Submitted That Met QC Criteria

October 11, 2024

First Posted (Actual)

October 15, 2024

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

October 11, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laser and PRF in periodontitis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe