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

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ClinicalTrials.gov Identifier: NCT05925179
Recruitment Status : Not yet recruiting
First Posted : June 29, 2023
Last Update Posted : July 19, 2023
Sponsor:
Information provided by (Responsible Party):
Mustafa YILMAZ, Biruni University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tooth Diseases Tooth Wear Procedure: Surgical crown lengthening Drug: Augmentin Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery
Estimated Study Start Date : August 1, 2023
Estimated Primary Completion Date : October 1, 2023
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
Experimental: antibiotic prophylaxis
per os 2 g augmentin one hour prior to surgery
 Procedure: Surgical crown lengthening
Surgical clinical crown lengthening with bone excision

Drug: Augmentin
Pre-operative antibiotic prophylaxis (2 g Augmentin)
Placebo Comparator: placebo control
per os placebo one hour prior to surgery
 Procedure: Surgical crown lengthening
Surgical clinical crown lengthening with bone excision


Outcome Measures
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Primary Outcome Measures :
  1. Early healing index (inflammation phase) [ Time Frame: at 3 days ]

    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


  2. Early healing index (proliferation phase) [ Time Frame: at 10 days ]

    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


  3. Early healing index (remodeling phase) [ Time Frame: at 6 weeks ]

    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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05925179


Contacts
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Contact: Mustafa YILMAZ, PhD, DDS +902124440276 myilmaz@biruni.edu.tr
Contact: Ayse Ege Selman, DDS +902124440276 aselman@biruni.edu.tr

Sponsors and Collaborators
Biruni University
More Information
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Publications:

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Responsible Party: Mustafa YILMAZ, Assistant Professor, Biruni University
ClinicalTrials.gov Identifier: NCT05925179    
Other Study ID Numbers: Antibiotics crown lengthening
First Posted: June 29, 2023    Key Record Dates
Last Update Posted: July 19, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Diseases
Tooth Wear
Stomatognathic Diseases
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
 Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action