Evaluation of the Effect of Incorporation of Vitamin C Into Platelet Rich Fibrin Scaffold in Treatment of Intra-osseous Periodontal Defects

Study Overview
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Brief Summary
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This study is meant to assess clinically the possible predictable clinical attachment gain regarding the use of vitamin C with platelet rich fibrin versus platelet rich fibrin alone in the treatment of periodontal intrabony defects

Detailed Description
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Treatment of intra-osseous defects through incorporation of vitamin C into platelet rich fibrin scaffold aims to enhance the biologic potential of the endogenous mesenchymal stem cells that exist within the periodontal ligaments and stimulate periodontal tissue regeneration(Yan et al., 2013). As the concept of periodontal tissue-engineering has emerged, many inductive biomolecules were investigated for periodontal regeneration(Bartold et al., 2000). Vitamin C has shown promising results in periodontal regeneration, in a study vitamin C was suggested to enhance osteoblastic differentiation of periodontal ligament cells through modulating type I collagen-α1β2 integrin interaction leading to increased ALP activity in periodontal ligament cells(Ishikawa et al., 2004). Vitamin C treatment induces expression of cementogenic genes and considered to be a more feasible and safer treatment for clinical cell-based periodontal regeneration(Gauthier et al., 2017). There is also a study concluding that vitamin C induces the osteogenic differentiation of PDL progenitor cells via PELP1-ERK axis; and this implies that vitamin C may have a potential in the periodontal regeneration(Yan et al., 2013). Periodontal tissue regeneration aims to increase periodontal in intra-osseous defects thus improving clinical attachment level; reducing probing depth and upgrading the prognosis of teeth(Ramseier et al., 2012). Resolution of intra-osseous defects through regeneration preserves and improves function and provides patient comfort(Wang et al., 2005). It also facilitates supportive periodontal therapy; performed regularly to maintain periodontal health(Ramseier et al., 2012).

Official Title
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The Effect of Combination of Vitamin C and Platelet Rich Fibrin (PRF) Versus Platelet Rich Fibrin Alone on Clinical Attachment Gain in Patients With Stage III Periodontitis: A Randomized Controlled Clinical Trial

Conditions
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Periodontal Bone Loss

Intervention / Treatment
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* Combination Product: combination of vitamin C and platelet rich fibrin


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

Accepts Healthy Volunteers
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No

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 |
| --- | --- |
| Experimental: Intervention<br>250 μM of vitamin C will be used with the platelet rich fibrin | Combination Product: combination of vitamin C and platelet rich fibrin<br>* combination of vitamin C and platelet rich fibrin<br>|
| Active Comparator: Comparator<br>using platelet rich fibrin alone | Combination Product: combination of vitamin C and platelet rich fibrin<br>* combination of vitamin C and platelet rich fibrin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gain in clinical attachment level | Measured from the CEJ to the bottom of the gingival sulcus | 6 months |