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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Intrabony Periodontal Defect

Intervention / Treatment
-----------------
* Procedure: Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C
* Procedure: Modified minimally invasive surgical technique with PRF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient-related criteria: Patient consulting in the outpatient clinic with periodontitis stage III Able to tolerate surgical periodontal procedures. Patient ready to perform oral hygiene instructions. Compliance with the maintenance program. Provide informed consent. Accepts the 6 months follow-up period. Teeth related criteria: Mature permanent tooth. Tooth with two or three-walled intra-bony defect, with CAL ≥ 5mm and intra osseous defect ≥ 3mm. Exclusion Criteria: Patient-related criteria: Medically compromised patients. Pregnant or nursing women. Uncooperative patients. Smokers. Teeth related criteria: Teeth with one wall intra-bony defect. Teeth with supra-bony defects. Teeth with grade III mobility.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C<br>Surgical 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. | Procedure: Experimental: Modified minimally invasive surgical technique with PRF and vitamins A and C<br>* Surgical 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.<br>|
| Active Comparator: Modified minimally invasive surgical technique with PRF<br>Surgical technique (M-MIST) with the same procedures will be performed. Approximately 10 mm of whole blood is drawn by venipuncture of the antecubital vein and is collected into two blood collection tubes without anticoagulant for PRF preparation.The resultant PRF clot will be placed into the intra-osseous defect | Procedure: Modified minimally invasive surgical technique with PRF<br>* Surgical 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic linear defect depth (mm) | Digital Radiographs using ImageJ software, Measured as the depth of intra-osseous defect from the alveolar crest to the defect. | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth (mm) | Measured from the gingival margin to the bottom of the gingival sulcus | 9 months | 
| Clinical Attachment Level (mm) | Measured from the CEJ to the bottom of the gingival sulcus | 9 months | 
| Gingival Recession Depth (mm) | Measured from the CEJ to the most apical extension of the gingival margin | 9 months |