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Predetermination for Gingival Recession

Primary Purpose

Gingival Recessions

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Coronally advanced flap with connective tissue graft
Sponsored by
Cukurova University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gingival Recessions focused on measuring prognostic factors

Eligibility Criteria

20 Years - 42 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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;

Exclusion Criteria:

Exclusion criteria were:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Other

    Other

    Arm Label

    gingival recession type 1

    gingival recession type 2

    Arm Description

    recession defects without CAL intervention:Coronally advanced flap with connective tissue graft

    gingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft

    Outcomes

    Primary Outcome Measures

    values of baseline interdental papill height
    in mm

    Secondary Outcome Measures

    avascular exposed root surface area
    .n mm2
    interdental clinical attachment level
    in mm

    Full Information

    First Posted
    June 17, 2015
    Last Updated
    June 19, 2015
    Sponsor
    Cukurova University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02479633
    Brief Title
    Predetermination for Gingival Recession
    Official Title
    Predetermınatıon of Root Coverage for Recessıons Treated wıth Coronally Advanced Flap wıth Connectıve Tissue Graft: An Exploratıve Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2013 (undefined)
    Primary Completion Date
    January 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cukurova University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    The coronally advanced flap (CAF) with connective tissue graft (CTG) has been confirmed as the gold standard for treatment of gingival recessions ). CTG-based procedures provide the best outcomes with superior percentages of mean root coverage (MRC) and complete root coverage (CRC) and keratinized tissue (KT) gain. Data in previous reports show CRC range from 18% to 83% after CAF+CTG in Miller Classes I and II defects which are associated with no inter-dental clinical attachment loss (interdental-CAL) (Recession Type 1-RT1) The use of CTG under CAF significantly enhances the probability to achieve CRC (%57) in recessions in which interdental-CAL is equal or smaller than the buccal attachment loss (Recession Type 2-RT2). It has been emphasized that CRC percentage was very similar to the result (60%) of a multicentre study on the treatment of RT1 recessions (Cortellini et al. 2009). Moreover, CRC was higher than most of the reports on treatment of RT1 or Miller I and II defects (more than 80%) when baseline interdental-CAL was between 1 and 3 mm Therefore, various CRC outcomes of the literature indicate that there is need for additional defect defining criteria for predicting the outcomes of root coverage (RC) in RT 1 and RT2 (interdental-CAL≤ 3mm) recession defects. Predetermination of final RC which is important for distinguishing 'expected versus actual' amount of RC was found to be related to inter-dental papilla height (IPH) and inter-dental clinical attachment level (ICAL) by the clinical studies which reported correlation between these two anatomical characteristics and CRC. Recently a new predictive classification of gingival recessions using the baseline avascular exposed root surface area (AERSA) as an identification criterion has been proposed. AERSA resulted as a strong predictor of final RC after laterally positioned flap (LPF) leading to a prognostic model with AERSA explaining 86% of the mean root coverage. In addition, due to anatomic variations, some Miller Class I defects may have larger AERSA than Miller Class II and III defects or there may be smaller Miller Class III defects than Miller Class I and II defects which may significantly influence the treatment results. These results could help to explain the outcome variations among previous studies. The prognostic anticipation of a certain amount of RC is a complex process including patient-related, tooth/site-related (GRD, root abrasion, ICAL, tooth type, the dimension of inter-dental papilla, AERSA) and technique-related (e.g. quality of the CTG) factors and operator's skill. It is essential to define the most potent prognostic factors' combination which can increase the success and predictability rates, to make CAF+CTG the most convenient RC technique for patients and clinicians. Therefore the aim of this study was to explore the predictive values of baseline IPH, AERSA and ICAL measurements on the final RC outcomes after CAF+CTG in RT1 and RT2 class GR defects.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recessions
    Keywords
    prognostic factors

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    122 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    gingival recession type 1
    Arm Type
    Other
    Arm Description
    recession defects without CAL intervention:Coronally advanced flap with connective tissue graft
    Arm Title
    gingival recession type 2
    Arm Type
    Other
    Arm Description
    gingival recession with an amount of CAL equal or smaller to the buccal CAL. Intervention: Coronally advanced flap with connective tissue graft
    Intervention Type
    Other
    Intervention Name(s)
    Coronally advanced flap with connective tissue graft
    Other Intervention Name(s)
    CAF+CTG
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    values of baseline interdental papill height
    Description
    in mm
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    avascular exposed root surface area
    Description
    .n mm2
    Time Frame
    1 year
    Title
    interdental clinical attachment level
    Description
    in mm
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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; Exclusion Criteria: Exclusion criteria were: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Onur Ozcelik, Prof. Dr
    Organizational Affiliation
    Professor
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Predetermination for Gingival Recession

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