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NCT Number: NCT06641739

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. -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]

  2. 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.

Secondary outcomes

  1. -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.
  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

AlAlzahraa Ahmed Ibrahim Alghriany, lecturer

CONTACT

[email protected]

+201203770058

Nashwa Helaly Mohamed, lecturer

CONTACT

[email protected]

+2001002226405

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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