Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects

Study Overview
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Brief Summary
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Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?

Detailed Description
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Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019). Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.

Official Title
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Clinical Evaluation of Periodontal Regeneration Using Vitamin A Added to PRF in Comparison to PRF Alone in Treatment of Intra-bony Defects: Randomized Controlled Clinical Trial

Conditions
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Intrabony Periodontal Defect

Intervention / Treatment
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* Biological: Platelet Rich Fibrin (PRF)
* Biological: Platelet Rich Fibrin (PRF) and Retinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects. Non-smokers No pregnancy Medically free Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm; Presence of ≥2 mm of keratinized gingiva at the tooth with the defect. Willingness to optimal compliance with the study procedures Exclusion Criteria: Uncontrolled systemic or local infection in the tissue of interest, History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV). History of chronic autoimmune disease Participation in an intervention trial in the same quadrant in the previous two months. Type III tooth mobility, vertical root fracture in the selected tooth. Contraindications for periodontal surgery.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Control<br>PRF in intra-bony defects | Biological: Platelet Rich Fibrin (PRF)<br>* Platelet rich fibrin (PRF) in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)<br>|
| Experimental: Group 2 Experimental<br>PRF and Retinol in intra-bony defects | Biological: Platelet Rich Fibrin (PRF) and Retinol<br>* Platelet rich fibrin (PRF) mixed with Retinol in treatment of intrabony defects using Modified Minimally invasive surgical technique (M-MIST)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic linear defect depth | Measured as the depth of intra-osseous defect from the alveolar crest to the defect base (E et al., 2004) | 6 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical attachment level | clinical attachment level measured in mm. using williams graduated probe(SP, 1967) | 6 Month | 
| Probing pocket depth | Measuring probing depth in mm using William's graduated Periodontal probe (SP, 1967) | 6 Month | 
| Radiographic defect bone density | Bone density will be measured using Digital Radiographs using ImageJ software (B et al., 2019) | 6 MOnth |