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

Tooth Diseases Clinical Trial

— SCLABP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05925179
• Other study ID #: Antibiotics crown lengthening
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: July 2023
• Source: Biruni University
• Contact: Mustafa YILMAZ, PhD, DDS
• Phone: +902124440276
• Email: myilmaz[@]biruni.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Diseases
• Tooth Wear

Intervention

Procedure:
• Surgical crown lengthening
Surgical clinical crown lengthening with bone excision

Drug:
• Augmentin
Pre-operative antibiotic prophylaxis (2 g Augmentin)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 3 days
Primary	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	at 10 days
Primary	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	at 6 weeks