Clinical Evaluation of Injectable Platelet Rich Fibrin With Connective Tissue Graft for the Treatment of Deep Gingival Recession Defects.
1 other identifier
interventional
72
1 country
1
Brief Summary
Aim: The aim of this study was to determine whether the combined connective tissue graft (CTG) with injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF) improved root coverage of deep Miller Class I or II gingival recessions compared to CTG alone with CAF. Methods: Seventy-two patients with Miller class I and II gingival recessions were enrolled. Thirty-six patients were randomly assigned to the test group (CAF+CTG+i-prf) or control group (CAF+CTG). Clinical evaluations were made at 6 months
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedFirst Submitted
Initial submission to the registry
July 22, 2019
CompletedFirst Posted
Study publicly available on registry
July 25, 2019
CompletedJuly 25, 2019
July 1, 2019
11 months
July 22, 2019
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
gingival recession depth
the distance between the CEJ and gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
six months
Keratized tissue height
measured from the mucogingival junction to the gingival margin-measurements were performed at the midbuccal aspect of the teeth, by manual probe and were rounded up to the nearest millimetre
six months
Study Arms (2)
CAF+CTG
ACTIVE COMPARATORthe combined connective tissue graft (CTG) with coronally advanced flap (CAF)
CAF+CTG+i-prf
EXPERIMENTALthe combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Interventions
combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
Eligibility Criteria
You may qualify if:
- ≥19 years of age,
- Periodontally and systemically healthy,
- FMPS and FMBS \<15%,
- Presence of deep Miller class I and II gingival recession defect (≥3 mm in depth) at the buccal aspect of incisors,
You may not qualify if:
- Smoking,
- Contraindications for surgery,
- Presence of recession defects associated with caries, deep abrasion, restoration or pulpal pathology.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cukurova University
Adana, Balcalı, 01130, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
onur ucak Turer
CukurovaU Prof.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 22, 2019
First Posted
July 25, 2019
Study Start
November 1, 2017
Primary Completion
September 25, 2018
Study Completion
March 30, 2019
Last Updated
July 25, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share