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

Sponsor

Biruni University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05925179

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

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

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Jan 1, 2024

Arms and Interventions

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

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

Primary Outcome Measures

Early healing index (inflammation phase) [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
Early healing index (proliferation phase) [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
Early healing index (remodeling phase) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

No locations specified.

Sponsors and Collaborators

Biruni University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Mustafa YILMAZ, Assistant Professor, Biruni University

ClinicalTrials.gov Identifier:

NCT05925179

Other Study ID Numbers:

Antibiotics crown lengthening

First Posted:

Jun 29, 2023

Last Update Posted:

Jun 29, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tooth Diseases

Tooth Wear

Amoxicillin-Potassium Clavulanate Combination

Study Results

No Results Posted as of Jun 29, 2023