An interventional study of laser assisted SPPF and Platelet Rich Plasma in Periodontal Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-15.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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
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.
830 studies on the registry are indexed under Periodontal Diseases; 188 are open to participants now.
This study's planned enrollment of 20 is below the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
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Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
Ten patients will be treated with simplified papilla preservation flap with platelet-rich fibrin grafted into the defect site.
Procedure: Platelet Rich Plasma
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.
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.
-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: [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: [Time Frame: at base line, 1 month and 3 months after treatment]
-Plaque index (PI)
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: [Time Frame: at base line, 1 month and 3 months after treatment]
Gingival index (GI)
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: [Time Frame: at base line, 1 month and 3 months after treatment]
No study locations are listed for this record.
Plan to share: No
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Assiut University