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

Sponsor
Cairo University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03707483
Collaborator
(none)
20
2
12.9

Study Details

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
  • 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
Anticipated 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
Anticipated Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Nov 1, 2019
Anticipated Study Completion Date :
Mar 1, 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 [6 months]

    Measured from the CEJ to the bottom of the gingival sulcus

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Talaat Mohamed Mahmoud El Behwashy, Dentist, Cairo University
ClinicalTrials.gov Identifier:
NCT03707483
Other Study ID Numbers:
  • perio285reg
First Posted:
Oct 16, 2018
Last Update Posted:
Feb 7, 2019
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
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:

Study Results

No Results Posted as of Feb 7, 2019