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Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession

Primary Purpose

Recession, Gingival

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laterally Closed Tunnel with CTG
CAF with CTG
Sponsored by
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recession, Gingival

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket) Patients with good oral hygiene Medically free patients No signs of active periodontal disease (with no site showing probing depth > 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth). Palate with sufficient thickness to accommodate soft tissue defect. Exclusion Criteria: Smokers Pregnancy Severe gag reflex Non-carious cervical lesion History of mucogingival or periodontal surgery at the experimental site History of medication that can affect periodontal healing

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Laterally closed tunnel technique with CTG

    Coronally advanced flap with CTG

    Arm Description

    Outcomes

    Primary Outcome Measures

    Reduction in recession depth

    Secondary Outcome Measures

    Post-operative pain assessed by VAS Scale
    Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10, 0: no pain, 1: minimal pain 5: moderate pain, 10: severe pain)
    Probing Depth
    Clinical Attachment Level
    will be measured by a periodontal probe
    Width of Keratinized Tissue
    Gingival Thickness
    Percentage of complete root coverage by williams periodontal probe
    Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100

    Full Information

    First Posted
    February 16, 2023
    Last Updated
    April 19, 2023
    Sponsor
    British University In Egypt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05823415
    Brief Title
    Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession
    Official Title
    Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    March 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    British University In Egypt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate reduction of recession depth using lateral closed tunnel technique versus CAF technique using connective tissue graft in single RT2 gingival recession cases.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Laterally closed tunnel technique with CTG
    Arm Type
    Experimental
    Arm Title
    Coronally advanced flap with CTG
    Arm Type
    Active Comparator
    Intervention Type
    Procedure
    Intervention Name(s)
    Laterally Closed Tunnel with CTG
    Intervention Description
    A novel minimally invasive surgical approach laterally closed tunnel technique (LCT) has been recently introduced for the management of isolated gingival recession. The laterally closed tunnel technique ensures predictability by tunneling and mobilization of flap for graft coverage.
    Intervention Type
    Procedure
    Intervention Name(s)
    CAF with CTG
    Intervention Description
    Gold standard surgical technique
    Primary Outcome Measure Information:
    Title
    Reduction in recession depth
    Time Frame
    6 Months
    Secondary Outcome Measure Information:
    Title
    Post-operative pain assessed by VAS Scale
    Description
    Pain score reported by the patient directly through Visual Analogue Scale score (between 0 and 10, 0: no pain, 1: minimal pain 5: moderate pain, 10: severe pain)
    Time Frame
    2 week
    Title
    Probing Depth
    Time Frame
    6 months
    Title
    Clinical Attachment Level
    Description
    will be measured by a periodontal probe
    Time Frame
    6 months
    Title
    Width of Keratinized Tissue
    Time Frame
    6 months
    Title
    Gingival Thickness
    Time Frame
    6 months
    Title
    Percentage of complete root coverage by williams periodontal probe
    Description
    Preoperative vertical recession - Postoperative vertical recession/preoperative vertical recession) x 100
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Single RT2 buccal gingival recession ≥ 2 mm in the esthetic zone (Gingival recession associated with loss of inter-proximal attachment. The amount of interproximal attachment loss (measured from the interproximal CEJ to the depth of the interproximal pocket) was less than or equal to the buccal attachment loss (measured from the buccal CEJ to the depth of the buccal pocket) Patients with good oral hygiene Medically free patients No signs of active periodontal disease (with no site showing probing depth > 4 mm and full-mouth bleeding score (FMBS) 20% (measured at four sites per tooth). Palate with sufficient thickness to accommodate soft tissue defect. Exclusion Criteria: Smokers Pregnancy Severe gag reflex Non-carious cervical lesion History of mucogingival or periodontal surgery at the experimental site History of medication that can affect periodontal healing

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Clinical Evaluation of Laterally Closed Tunnel Technique Versus Coronally Advanced Flap Combined With Connective Tissue Graft for the Treatment of Isolated RT2 Gingival Recession

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