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Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap
restorative intervention
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • participants with at least one buccal gingival recession
  • O'Leary plaque index less than 20%
  • motivated participants willing to complete the follow up

Exclusion Criteria:

  • prior surgical or restorative interventions at the recession defect
  • smokers
  • pregnant participants
  • systemic conditions contraindicating dental management

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Treatment of gingival recession with colored composite

    Treatment of gingival recession with coronally advanced flap

    Arm Description

    Composite restoration will be applied to the gingival recession defect

    coronally advanced flap at the gingival defect

    Outcomes

    Primary Outcome Measures

    post-operative pain
    self-reported pain on visual analogue scale (VAS)

    Secondary Outcome Measures

    post-operative pain
    self-reported pain on VAS
    overall quality of life: questionnaire
    self reported through a questionnaire
    Reported post-operative satisfaction
    questionnaire
    mean root coverage
    percentage
    complete root coverage
    percentage
    Probing depth
    in mm
    Recession depth
    in mm
    Plaque index
    percentage
    Bleeding index
    percentage

    Full Information

    First Posted
    October 3, 2020
    Last Updated
    October 10, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04584931
    Brief Title
    Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap
    Official Title
    Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap: Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    December 30, 2022 (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
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Treatment of gingival recession requires favourable anatomical conditions and the use of invasive surgical approaches. Hence, these procedures are not always indicated in all cases and can cause great pain and morbidity. Coloured composite restorations that mimic the lost gingival tissues can provide a non-invasive and simple solution regardless of the recession soft and hard-tissue conditions.
    Detailed Description
    Gingival recession (also known as marginal tissue recession) is defined as the downward displacement of the soft tissues around teeth that would have been otherwise covering the cemento-enamel junction (CEJ), thus exposing the root surface clinically. Recession is one of the most prevalent mucogingival conditions worldwide, affecting between 30% to 100% of the overall population, and its incidence increases with age. Main concerns regarding recession ranging from unacceptable esthetics to the patient, dentinal hypersensitivity, development of carious and non-carious cervical lesions, or impairment of adequate plaque control. The ultimate aim for treating gingival recession is to provide complete coverage of the root with optimal esthetics and function. A wide range of surgical interventions have been investigated to provide for successful root coverage including rotational and advanced pedicle flaps, free gingival grafts, or regenerative modalities such as guided tissue regeneration. The predictability of surgical techniques depends on patient related factors such as smoking, oral hygiene care and compliance, defect related conditions like depth, width, gingival thickness and interdental attachment level, and finally, operator related skills and experience. Coronally advanced flap (CAF) with or without the use of connective tissue graft is considered the gold standard for root coverage due to its ability to achieve complete root coverage in favorable defects, superior esthetic outcomes and blending with surrounding gingiva, and the possible realignment and increase in keratinized tissue height. On the other hand, CAF is faced with multiple drawbacks. Complete root coverage in CAF procedures is not predictable in cases with interdental attachment loss. The surgery poses added morbidity, discomfort and pain, and donor site (if present) may augment these complications. Scar formation as a result of incisions or sutures may reduce the overall esthetic appeal. It requires frequent follow-up visits and arduous post-operative instructions. Post-operative results are not stable over long period of time with frequent relapse. The procedure cannot be performed in cases with systemic contraindications for surgical interventions. And finally, it is time-consuming and requires surgical skill and training of the operator. To overcome all of the abovementioned drawbacks of CAF, composite resin restorative material with pink shades known as "gingival composite" has been proposed to manage gingival recessions. Root coverage with composite is known to effectively reduce dentinal hypersensitivity effectively. Hence, managing gingival recession with this restorative procedure, the patients concerns regarding esthetics or hypersensitivity can be directly addressed using a simple and fast technique. Compared to CAF, restorative procedure shows less pain, morbidity and bleeding, and it does not involve surgical incisions/sutures and hence avoids no scar formation. Pink composite can be presented as a solution in cases that are not expected to benefit from CAF such as RT3, and it can treat carious and non-carious cervical lesions in one step. In addition, it requires less operative time and can be performed by general practitioners and with conventional armamentarium.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gingival Recession

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment of gingival recession with colored composite
    Arm Type
    Experimental
    Arm Description
    Composite restoration will be applied to the gingival recession defect
    Arm Title
    Treatment of gingival recession with coronally advanced flap
    Arm Type
    Active Comparator
    Arm Description
    coronally advanced flap at the gingival defect
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap
    Intervention Description
    flap surgery to achieve root coverage at gingival recession defect
    Intervention Type
    Procedure
    Intervention Name(s)
    restorative intervention
    Intervention Description
    colored composite restoration to camouflage the gingival recession defect
    Primary Outcome Measure Information:
    Title
    post-operative pain
    Description
    self-reported pain on visual analogue scale (VAS)
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    post-operative pain
    Description
    self-reported pain on VAS
    Time Frame
    1,3,5,14 days
    Title
    overall quality of life: questionnaire
    Description
    self reported through a questionnaire
    Time Frame
    6 months
    Title
    Reported post-operative satisfaction
    Description
    questionnaire
    Time Frame
    6 months
    Title
    mean root coverage
    Description
    percentage
    Time Frame
    6 months
    Title
    complete root coverage
    Description
    percentage
    Time Frame
    6 months
    Title
    Probing depth
    Description
    in mm
    Time Frame
    baseline, 6 months
    Title
    Recession depth
    Description
    in mm
    Time Frame
    baseline, 6 months
    Title
    Plaque index
    Description
    percentage
    Time Frame
    baseline, 6 months
    Title
    Bleeding index
    Description
    percentage
    Time Frame
    baseline, 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: participants with at least one buccal gingival recession O'Leary plaque index less than 20% motivated participants willing to complete the follow up Exclusion Criteria: prior surgical or restorative interventions at the recession defect smokers pregnant participants systemic conditions contraindicating dental management
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Elfana, MSc
    Phone
    +2011101102221
    Email
    ahmed.abdelraouf@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    Karim Fawzy El-Sayed, PhD

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Treatment of Gingival Recession Using Gingival Composite Restoration Versus Coronally Advanced Flap

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