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Management of Miller Class I & II Gingival Recession

Primary Purpose

Gingival Recession

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronally advanced flap with abrasive de-epithelized graft.
coronally advanced flap with de-epithelized graft.
Sponsored by
Halla Gamal Mohammed Esmail
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingival Recession

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age ≥ 18 years.
  • Systemically healthy patients.
  • Miller's Class I and II recession defects with recession depth ≥ 2mm.
  • Presence of identifiable cemento-enamel junction (CEJ).
  • Clinical indication and/or patient request for recession coverage.
  • Smoking ≤ 10 cigarettes/day.
  • Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

  • Pregnant females.
  • Smoking ˃ 10 cigarettes/day.
  • Contraindication for periodontal surgery.
  • Patients with poor oral hygiene.
  • Recession defects associated with caries or restoration as well as
  • Teeth with evidence of a pulpal pathology
  • Molar teeth

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Test group

    Control group

    Arm Description

    SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)

    SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)

    Outcomes

    Primary Outcome Measures

    Direct Post-operative pain
    Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
    Indirect Post-operative pain
    Indirectly will be evaluated on the basis of the mean consumption of analgesics

    Secondary Outcome Measures

    Complete Root Coverage
    CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ
    Recession depth.
    Measured from the CEJ to the most apical extension of the gingival margin
    Gingival Recession Width
    measured at the level of the CEJ.
    Width Of Keratinized Gingiva
    Measured from the gingival margin to the mucogingival line
    Root Coverage Esthetic Score
    The RES system evaluates five variables 6 months following surgery
    Gingival thickness
    It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.
    Surgical chair time
    measured by Stop watch

    Full Information

    First Posted
    November 29, 2018
    Last Updated
    January 16, 2019
    Sponsor
    Halla Gamal Mohammed Esmail
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03767309
    Brief Title
    Management of Miller Class I & II Gingival Recession
    Official Title
    Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 1, 2019 (Anticipated)
    Primary Completion Date
    January 1, 2020 (Anticipated)
    Study Completion Date
    December 1, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Halla Gamal Mohammed Esmail

    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
    Management of Miller class I & II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.

    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
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Test group
    Arm Type
    Experimental
    Arm Description
    SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)
    Arm Title
    Control group
    Arm Type
    Active Comparator
    Arm Description
    SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap with abrasive de-epithelized graft.
    Intervention Description
    SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur
    Intervention Type
    Procedure
    Intervention Name(s)
    coronally advanced flap with de-epithelized graft.
    Intervention Description
    SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade
    Primary Outcome Measure Information:
    Title
    Direct Post-operative pain
    Description
    Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.
    Time Frame
    7 days
    Title
    Indirect Post-operative pain
    Description
    Indirectly will be evaluated on the basis of the mean consumption of analgesics
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Complete Root Coverage
    Description
    CRC evaluated in patients by single operator clinically using a periodontal probe. Root coverage was deemed complete when the gingival margin is at or above the level of CEJ
    Time Frame
    6 months
    Title
    Recession depth.
    Description
    Measured from the CEJ to the most apical extension of the gingival margin
    Time Frame
    6 months
    Title
    Gingival Recession Width
    Description
    measured at the level of the CEJ.
    Time Frame
    6 months
    Title
    Width Of Keratinized Gingiva
    Description
    Measured from the gingival margin to the mucogingival line
    Time Frame
    6 months
    Title
    Root Coverage Esthetic Score
    Description
    The RES system evaluates five variables 6 months following surgery
    Time Frame
    6 months
    Title
    Gingival thickness
    Description
    It will be measured by penetrating the gingiva mid-buccally in the attached gingiva, half way between mucogingival junction and free gingival groove with the periodontal probe after giving local anesthesia to measure the thickness of gingival tissues.
    Time Frame
    6 months
    Title
    Surgical chair time
    Description
    measured by Stop watch
    Time Frame
    at the time of surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years. Systemically healthy patients. Miller's Class I and II recession defects with recession depth ≥ 2mm. Presence of identifiable cemento-enamel junction (CEJ). Clinical indication and/or patient request for recession coverage. Smoking ≤ 10 cigarettes/day. Cooperative patients able and accept to come for follow up appointments. Exclusion Criteria: Pregnant females. Smoking ˃ 10 cigarettes/day. Contraindication for periodontal surgery. Patients with poor oral hygiene. Recession defects associated with caries or restoration as well as Teeth with evidence of a pulpal pathology Molar teeth

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Management of Miller Class I & II Gingival Recession

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