Evaluation of the Effect of Incorporation of Vitamin C Into Platelet Rich Fibrin Scaffold in Treatment of Intra-osseous Periodontal Defects
Primary Purpose
Periodontal Bone Loss
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
combination of vitamin C and platelet rich fibrin
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Comparator
Arm Description
250 μM of vitamin C will be used with the platelet rich fibrin
using platelet rich fibrin alone
Outcomes
Primary Outcome Measures
gain in clinical attachment level
Measured from the CEJ to the bottom of the gingival sulcus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03707483
Brief Title
Evaluation of the Effect of Incorporation of Vitamin C Into Platelet Rich Fibrin Scaffold in Treatment of Intra-osseous Periodontal Defects
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 2019 (Anticipated)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
March 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
250 μM of vitamin C will be used with the platelet rich fibrin
Arm Title
Comparator
Arm Type
Active Comparator
Arm Description
using platelet rich fibrin alone
Intervention Type
Combination Product
Intervention Name(s)
combination of vitamin C and platelet rich fibrin
Intervention Description
combination of vitamin C and platelet rich fibrin
Primary Outcome Measure Information:
Title
gain in clinical attachment level
Description
Measured from the CEJ to the bottom of the gingival sulcus
Time Frame
6 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
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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