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Trials / Unknown

UnknownNCT05499598

Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects

Clinical and Radiographic Evaluation of Modified Minimally Invasive Surgical Technique and Platelet Rich Fibrin With or Without Vitamin Pool A and C for Management of Periodontal Intrabony Defects: A Randomized Controlled Clinical Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
28 (estimated)
Sponsor
Cairo University · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Accepted

Summary

This study aims to assess clinical and radiographic outcomes after the use of vitamins A and C with PRF versus PRF alone in the treatment of periodontal intrabony defect.

Detailed description

Sites with deep intrabony defects were considered to be at a higher risk of disease progression if patients did not receive any systematic periodontal therapy. Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The optimal outcome of treatment in intrabony defects is considered to be the absence of bleeding on probing, the presence of shallow pockets associated with periodontal regeneration and limited soft tissue recession.The minimally invasive surgical technique is designed to mobilize just the defect-associated papilla and to reduce flap extension as much as possible. The modified minimally invasive surgical technique has been proposed to further reduce invasiveness and patient side effects by limiting the incision line to the buccal side. This technique fulfilled the maintenance of the interdental papillary height by minimizing its tendency to collapse, increased the likelihood of primary wound closure and reduced the chances of gingival recession. Platelet-rich fibrin is a powerful healing biomaterial with inherent regenerative capacity and can be used in the treatment of periodontal intrabony defects. Vitamin C is found to be able to induce osteogenic differentiation and maturation of progenitor cells of PDL without using osteogenic filling material. Also, Vitamin A has a unique property of de-differentiating adult cells into pluripotent cells. Since combination therapies have been shown to be effective in the regeneration of periodontal defects, this study will evaluate the synergetic effect of vitamins A and C on the periodontal regeneration, together with the most widely used regenerative biomaterial; Platelet-rich fibrin, as an attempt for finding the gold standard in the treatment of intra-bony defects.

Conditions

Interventions

TypeNameDescription
PROCEDUREExperimental: Modified minimally invasive surgical technique with PRF and vitamins A and CSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. Ascorbic Acid will be added to the fresh blood to achieve a concentration of 250 μg/ml, Retinol will also be added to achieve a concentration of 20 μmol/L. The resultant PRF clot will be placed into the intra-osseous defect.
PROCEDUREModified minimally invasive surgical technique with PRFSurgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of fresh blood will be drawn by venipuncture of the antecubital vein and collected into a blood collection tube without anticoagulant. The resultant PRF clot will be placed into the intra-osseous defect.

Timeline

Start date
2022-09-01
Primary completion
2022-11-01
Completion
2023-10-30
First posted
2022-08-12
Last updated
2022-08-12

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT05499598. Inclusion in this directory is not an endorsement.