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

• ClinicalTrials.gov Identifier: NCT03707483
• Recruitment Status: Unknown
• First Posted: October 16, 2018
• Last Update Posted: February 7, 2019
• Sponsor: Cairo University
• Information provided by (Responsible Party): Mohamed Talaat Mohamed Mahmoud El Behwashy, Cairo University

Study Description

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).

Study Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• 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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• 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
• Last Update Posted: February 7, 2019
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alveolar Bone Loss; Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Ascorbic Acid; Vitamins; Micronutrients; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents