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

July 18, 2023 updated by: Mustafa YILMAZ, Biruni University

Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at 3 days
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
at 10 days
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
at 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biruni University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

January 1, 2024

Study Registration Dates

First Submitted

June 21, 2023

First Submitted That Met QC Criteria

June 21, 2023

First Posted (Actual)

June 29, 2023

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Antibiotics crown lengthening

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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