Predetermination for Gingival Recession
Predetermınatıon of Root Coverage for Recessıons Treated wıth Coronally Advanced Flap wıth Connectıve Tissue Graft: An Exploratıve Study
1 other identifier
interventional
122
0 countries
N/A
Brief Summary
Background: The aim of present clinical study was to evaluate the predictive values of baseline inter-dental papilla height (IPH), avascular exposed root surface area (AERSA) and inter-dental clinical attachment loss (CAL) measurements on complete root coverage (CRC) of single gingival recession (GR) defects treated with coronally advanced flap and connective tissue graft technique (CAF+CTG). Material and Methods: The study group included 65 females and 57 males, aged between 20 and 42 years. A total of 122 recession defects without CAL and with an amount of CAL equal or smaller to the buccal CAL , located at upper and lower incisors and canines were treated with CAF+CTG. IPH, AERSA and CAL parameters were analyzed for possible correlation with CRC after 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 Jan 2013
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
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
June 17, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedJune 24, 2015
June 1, 2015
1 year
June 17, 2015
June 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
values of baseline interdental papill height
in mm
1 year
Secondary Outcomes (2)
avascular exposed root surface area
1 year
interdental clinical attachment level
1 year
Study Arms (2)
gingival recession type 1
OTHERrecession defects without CAL intervention:Coronally advanced flap with connective tissue graft
gingival recession type 2
OTHERgingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft
Interventions
Two oblique, divergent releasing incisions extending beyond the mucogingival junction were performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth. Subsequently, a partial-thickness flap was raised beyond the MGJ. The papilla adjacent to the involved tooth were then de-epithelialized. The CTG was harvested using a single incision approach from the palate. The graft was positioned on the instrumented root surface immediately apical of the CEJ and then stabilized using a sling compressive crossing suture. The flap was coronally displaced 1-2 mm above the CEJ. A sling suture was placed to stabilize the flap in a coronal position, followed by interrupted sutures on the releasing incisions with an apico-coronal direction.
Eligibility Criteria
You may qualify if:
- Presence of isolated RT1 and RT2 class gingival recessions with an AERSA ˃9mm2 on upper and lower incisors,
- Presence of identifiable cemento-enamel junction (CEJ); presence of a step ≤1mm at the CEJ level and/or the presence of a root abrasion, but with an identifiable CEJ,
- Full-mouth plaque score and Full-mouth bleeding score of \<15%,
- No occlusal interferences;
You may not qualify if:
- Patients with a history of periodontitis or abscess formation,
- Mucogingival or periodontal surgery at the experimental site in the last 1 year,
- Presence of systemic disease or taking medication known to interfere with periodontal tissue health,
- Smokers, pregnant patients.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Onur Ozcelik, Prof. Dr
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 17, 2015
First Posted
June 24, 2015
Study Start
January 1, 2013
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
June 24, 2015
Record last verified: 2015-06