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

NCT ID: NCT03707483

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-28
• Study Completion Date: 2020-03-31

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).

Conditions

Periodontal Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

250 μM of vitamin C will be used with the platelet rich fibrin

Group Type: EXPERIMENTAL

combination of vitamin C and platelet rich fibrin

Intervention Type: COMBINATION_PRODUCT

combination of vitamin C and platelet rich fibrin

Comparator

using platelet rich fibrin alone

Group Type: ACTIVE_COMPARATOR

combination of vitamin C and platelet rich fibrin

Intervention Type: COMBINATION_PRODUCT

combination of vitamin C and platelet rich fibrin

Interventions

combination of vitamin C and platelet rich fibrin

combination of vitamin C and platelet rich fibrin

Intervention Type: COMBINATION_PRODUCT

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Talaat Mohamed Mahmoud El Behwashy

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

perio285reg

Identifier Type: -

Identifier Source: org_study_id