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

Phase 2

• Conditions: Periodontal Bone Loss
• Interventions: Combination Product: combination of vitamin C and platelet rich fibrin

• Registration Number: NCT03707483
• Lead Sponsor: Cairo University

Brief Summary

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

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).

Study Timeline

• Status Verified: 2018-10
• Study First Submitted: 2018-10-12
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-16
• Study Start: 2019-02
• Last Update Submitted: 2019-02-06
• Last Update Posted: 2019-02-07
• Primary Completion: 2019-11
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	combination of vitamin C and platelet rich fibrin	250 μM of vitamin C will be used with the platelet rich fibrin
Comparator	combination of vitamin C and platelet rich fibrin	using platelet rich fibrin alone

Primary Outcome Measures

Name	Time	Method
gain in clinical attachment level	6 months	Measured from the CEJ to the bottom of the gingival sulcus