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

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ClinicalTrials.gov Identifier: NCT03707483
Recruitment Status : Unknown
Verified October 2018 by Mohamed Talaat Mohamed Mahmoud El Behwashy, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : February 7, 2019
Sponsor:
Information provided by (Responsible Party):
Mohamed Talaat Mohamed Mahmoud El Behwashy, 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

Condition or disease Intervention/treatment Phase
Periodontal Bone Loss Combination Product: combination of vitamin C and platelet rich fibrin Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: Intervention
250 μM of vitamin C will be used with the platelet rich fibrin
Combination Product: combination of vitamin C and platelet rich fibrin
combination of vitamin C and platelet rich fibrin

Active Comparator: Comparator
using platelet rich fibrin alone
Combination Product: combination of vitamin C and platelet rich fibrin
combination of vitamin C and platelet rich fibrin




Primary Outcome Measures :
  1. gain in clinical attachment level [ Time Frame: 6 months ]
    Measured from the CEJ to the bottom of the gingival sulcus



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Mohamed Talaat Mohamed Mahmoud El Behwashy, Dentist, Cairo University
ClinicalTrials.gov Identifier: NCT03707483    
Other Study ID Numbers: perio285reg
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: February 7, 2019
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alveolar Bone Loss
Bone Resorption
Bone Diseases
Musculoskeletal Diseases
Periodontal Atrophy
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Ascorbic Acid
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents