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Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening (SCLABP)

Primary Purpose

Tooth Diseases, Tooth Wear

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Surgical crown lengthening
Augmentin
Sponsored by
Biruni University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth Diseases

Eligibility Criteria

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

Inclusion Criteria: in need of surgical crown lengthening operation in one/two teeth Exclusion Criteria: systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus antibiotic or anti-inflammatory drug use in the last 3 months pregnancy/lactation chronic steroid, immunosuppressant or NSAD use age <18 years positive bleeding on probing at the surgical site and/or active periodontal disease <2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation) Miller 2 or 3 tooth mobility penicillin allergy unwilling to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    antibiotic prophylaxis

    placebo control

    Arm Description

    per os 2 g augmentin one hour prior to surgery

    per os placebo one hour prior to surgery

    Outcomes

    Primary Outcome Measures

    Early healing index (inflammation phase)
    Scores are given as specified below (Hamzani et al. 2018) Bleeding (spontaneous or provoked) Yes: 0; No: 1 Granulation tissue Yes: 0; No: 1 Hematoma Yes: 0; No: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Incision margins Incomplete flap closure/fibrin clot/partial or complete necrosis: 0; Complete closure/fine fibrin line: 1 Suppuration Yes: 0; No: 1 Edema VAS 6-10: 0; VAS 1-5: 1 Pain VAS 6-10: 0; VAS 1-5: 1
    Early healing index (proliferation phase)
    Scores are given as specified below (Hamzani et al. 2018) Re-epithelization Partial: 0; Complete: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Suppuration Yes: 0; No: 1 Pain VAS 6-10: 0; VAS 1-5: 1
    Early healing index (remodeling phase)
    Scores are given as specified below (Hamzani et al. 2018) Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Pain VAS 6-10: 0; VAS 1-5: 1

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    July 18, 2023
    Sponsor
    Biruni University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05925179
    Brief Title
    Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening
    Acronym
    SCLABP
    Official Title
    Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    October 1, 2023 (Anticipated)
    Study Completion Date
    January 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Biruni 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
    The goal of this clinical trial is to test the effects of prophylactic antibiotics in healthy individuals who are in need of surgical crown lengthening. The main question it aims to answer is if single dose antibiotics prior to surgical crown lengthening has any effects on the healing outcomes. Participants will be asked to take either 2 g of amoxicillin + clavulanate, or placebo, one hour prior to surgery and without knowing what medicine they took. Researchers will compare the wound healing and self-reported outcomes of the antibiotics group and placebo group.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth Diseases, Tooth Wear

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    28 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    antibiotic prophylaxis
    Arm Type
    Experimental
    Arm Description
    per os 2 g augmentin one hour prior to surgery
    Arm Title
    placebo control
    Arm Type
    Placebo Comparator
    Arm Description
    per os placebo one hour prior to surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical crown lengthening
    Intervention Description
    Surgical clinical crown lengthening with bone excision
    Intervention Type
    Drug
    Intervention Name(s)
    Augmentin
    Intervention Description
    Pre-operative antibiotic prophylaxis (2 g Augmentin)
    Primary Outcome Measure Information:
    Title
    Early healing index (inflammation phase)
    Description
    Scores are given as specified below (Hamzani et al. 2018) Bleeding (spontaneous or provoked) Yes: 0; No: 1 Granulation tissue Yes: 0; No: 1 Hematoma Yes: 0; No: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Incision margins Incomplete flap closure/fibrin clot/partial or complete necrosis: 0; Complete closure/fine fibrin line: 1 Suppuration Yes: 0; No: 1 Edema VAS 6-10: 0; VAS 1-5: 1 Pain VAS 6-10: 0; VAS 1-5: 1
    Time Frame
    at 3 days
    Title
    Early healing index (proliferation phase)
    Description
    Scores are given as specified below (Hamzani et al. 2018) Re-epithelization Partial: 0; Complete: 1 Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Suppuration Yes: 0; No: 1 Pain VAS 6-10: 0; VAS 1-5: 1
    Time Frame
    at 10 days
    Title
    Early healing index (remodeling phase)
    Description
    Scores are given as specified below (Hamzani et al. 2018) Tissue color Redder or whiter than opposite site: 0; Similar to opposite site: 1 Scar wider than 2 mm/contour irregularity: 0; scar less than 2 mm/contour regularity: 1 Pain VAS 6-10: 0; VAS 1-5: 1
    Time Frame
    at 6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: in need of surgical crown lengthening operation in one/two teeth Exclusion Criteria: systemic diseases which may affect periodontal tissues and/or healing process such as diabetes mellitus antibiotic or anti-inflammatory drug use in the last 3 months pregnancy/lactation chronic steroid, immunosuppressant or NSAD use age <18 years positive bleeding on probing at the surgical site and/or active periodontal disease <2 mm keratinized mucosa at the surgical site following surgery (estimated surgical outcome before the operation) Miller 2 or 3 tooth mobility penicillin allergy unwilling to participate
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mustafa YILMAZ, PhD, DDS
    Phone
    +902124440276
    Email
    myilmaz@biruni.edu.tr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ayse Ege Selman, DDS
    Phone
    +902124440276
    Email
    aselman@biruni.edu.tr

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30324746
    Citation
    Hamzani Y, Chaushu G. Evaluation of early wound healing scales/indexes in oral surgery: A literature review. Clin Implant Dent Relat Res. 2018 Dec;20(6):1030-1035. doi: 10.1111/cid.12680. Epub 2018 Oct 15.
    Results Reference
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    Effects of Antibiotic Prophylaxis on the Healing Parameters Following Surgical Crown Lengthening

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