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Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health

Primary Purpose

Gingival Retraction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
retraction cord
subgingival clamp
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gingival Retraction

Eligibility Criteria

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

Inclusion Criteria:

  • Subject not less than 18 years of age.
  • Males or females.
  • Have at least one carious or non-carious cervical lesion.
  • Cervical lesions should be equi-gingival or subgingival.
  • Can comply to oral hygiene measures or with good oral hygiene.
  • Have sufficient cognitive ability to understand consent procedures.
  • Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis.
  • Clinically healthy gingiva and periodontium.
  • No evidence of attachment loss, bleeding on probing, or plaque accumulation.

Exclusion criteria:

  • Exclusion Criteria:
  • Patients less than 18 years old.
  • Disabilities (mental health conditions, intellectual disability and physical disabilities).
  • Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic.
  • Lack of compliance.
  • Gingival hyperplasia, blood disorder.
  • Attachment loss signs of periodontal disease.
  • Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy).
  • Periapical pathosis or signs of pulpal posterior or anterior pathology.
  • Non-vital tooth.
  • Endodontically treated tooth.
  • Sever periodontal affection.
  • Tooth indicated for extraction.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    retraction cord

    subgingival clamp

    Arm Description

    Outcomes

    Primary Outcome Measures

    Time of application
    Assessed using timer and the measuring unite is seconds
    Number of patients need local anesthesia
    It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
    Degree of isolation from cervical fluids
    Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
    Degree of patient satisfaction
    Using visual analogue scale (units on scale from 0-10)

    Secondary Outcome Measures

    Pink esthetics evaluation
    Using a pink esthetic score with a grades from 0-2
    Amount of gingival bleeding
    Assessed using a score for gingival hemorrhage from 0 -2
    Presence of gingival laceration
    Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
    Degree of gingival sensitivity
    Assessed using visual analogue scale (units on scale from 0-10)

    Full Information

    First Posted
    April 11, 2019
    Last Updated
    April 15, 2019
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03917108
    Brief Title
    Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health
    Official Title
    Assessment of Technique Sensitivity and Gingival Health in Management of Cervical Lesions Performed Using Subgingival Clamp Versus Retraction Cord: A Randomized Controlled Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2019 (Anticipated)
    Primary Completion Date
    September 2019 (Anticipated)
    Study Completion Date
    October 2019 (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

    5. Study Description

    Brief Summary
    assessing subgingival clamp in handling and retracting the gingival tissue at the cervical area to see its effect on the gingival health and its technique sensitivity compared to the most commonly used method (retraction cord), as gingival displacement for cervical restorations affects smile and therefore patient satisfaction with the result.
    Detailed Description
    Gingival displacement for restoring cervical lesions using retraction cord or subgingival clamp with their technique sensitivity affects the smile as they may cause gingival bleeding, laceration or recession and therefore affects patient satisfaction. There are several methods to achieve retraction; retraction cord is the most commonly used method. It controls the soft tissue displacement, gingival bleeding and expose the margins which provide good visualization and access. They are effective and safe if the gingiva is healthy, also inexpensive retraction method. However, the use of retraction cord has some disadvantages like: it is time consuming, may cause gingival recession after healing and bleeding after removal, its application needs practice and skill as improper handling of the cord can cause traumatic injuries, gingival recession and marginal exposure of the restoration, it may cause postoperative discomfort and pain for the patient and finally leaving the retraction cord for long time or forgetting to remove it from the sulcus can cause permanent damage to the gingival tissue. Using gingival retracting clamps with rubber dam isolation prevent the gap caused around the teeth due to vertical and horizontal tissue displacement occurred beneath the area of dento-gingival attachment upon the application of the retraction cord. Also, after clamp stabilization in position, it prevents accidental slippage and trauma to surrounding soft tissue during the restorative procedure. They also provide maximum tissue retraction without laceration of gingival tissues. Also, their availability in different sizes and shapes provide a good adaptation to any tooth configuration and any inaccessible area.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    retraction cord
    Arm Type
    Active Comparator
    Arm Title
    subgingival clamp
    Arm Type
    Other
    Intervention Type
    Device
    Intervention Name(s)
    retraction cord
    Intervention Description
    retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.
    Intervention Type
    Device
    Intervention Name(s)
    subgingival clamp
    Intervention Description
    subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation
    Primary Outcome Measure Information:
    Title
    Time of application
    Description
    Assessed using timer and the measuring unite is seconds
    Time Frame
    Immediately after application
    Title
    Number of patients need local anesthesia
    Description
    It will be measured by patient self assessment for the need of local anesthesia through a Yes/No question
    Time Frame
    Immediately after application
    Title
    Degree of isolation from cervical fluids
    Description
    Presence of cervical fluids will be assessed visually using magnifying loup with a Yes/No result
    Time Frame
    Immediately after application
    Title
    Degree of patient satisfaction
    Description
    Using visual analogue scale (units on scale from 0-10)
    Time Frame
    Immediately after application
    Secondary Outcome Measure Information:
    Title
    Pink esthetics evaluation
    Description
    Using a pink esthetic score with a grades from 0-2
    Time Frame
    4 month
    Title
    Amount of gingival bleeding
    Description
    Assessed using a score for gingival hemorrhage from 0 -2
    Time Frame
    4 month
    Title
    Presence of gingival laceration
    Description
    Occurence of gingival laceration assessed visually using magnifying loup with a Yes/No result
    Time Frame
    4 month
    Title
    Degree of gingival sensitivity
    Description
    Assessed using visual analogue scale (units on scale from 0-10)
    Time Frame
    4 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject not less than 18 years of age. Males or females. Have at least one carious or non-carious cervical lesion. Cervical lesions should be equi-gingival or subgingival. Can comply to oral hygiene measures or with good oral hygiene. Have sufficient cognitive ability to understand consent procedures. Vital upper or lower teeth with no signs or symptoms of irreversible pulpitis. Clinically healthy gingiva and periodontium. No evidence of attachment loss, bleeding on probing, or plaque accumulation. Exclusion criteria: Exclusion Criteria: Patients less than 18 years old. Disabilities (mental health conditions, intellectual disability and physical disabilities). Systemic diseases or severe medically compromised. (Cardiovascular disorder, diabetes, -hypertensive, epileptic. Lack of compliance. Gingival hyperplasia, blood disorder. Attachment loss signs of periodontal disease. Patients contra-indicated for rubber dam placement (Asthmatic patient, mouth breather, -- partially erupted tooth, extremely malposed teeth and latex allergy). Periapical pathosis or signs of pulpal posterior or anterior pathology. Non-vital tooth. Endodontically treated tooth. Sever periodontal affection. Tooth indicated for extraction.

    12. IPD Sharing Statement

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    Subgingival Clamp Versus Retraction Cord in Cervical Lesions in Term of Technique Sensitivity and Gingival Health

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