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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

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

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03707483
Enrollment
20
Registered
2018-10-16
Start date
2019-02-28
Completion date
2020-03-31
Last updated
2019-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Bone Loss

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).

Interventions

COMBINATION_PRODUCTcombination of vitamin C and platelet rich fibrin

combination of vitamin C and platelet rich fibrin

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
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.

Design outcomes

Primary

MeasureTime frameDescription
gain in clinical attachment level6 monthsMeasured from the CEJ to the bottom of the gingival sulcus

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026