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

Phase 4

Not yet recruiting

• Conditions: Tooth Diseases; Tooth Wear
• Interventions: Procedure: Surgical crown lengthening; Drug: Augmentin

• Registration Number: NCT05925179
• Lead Sponsor: Biruni University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-21
• Study First Submitted QC: 2023-06-21
• Study First Posted: 2023-06-29
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-19
• Study Start: 2023-08-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• in need of surgical crown lengthening operation in one/two teeth

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo control	Surgical crown lengthening	per os placebo one hour prior to surgery
antibiotic prophylaxis	Surgical crown lengthening	per os 2 g augmentin one hour prior to surgery
antibiotic prophylaxis	Augmentin	per os 2 g augmentin one hour prior to surgery

Primary Outcome Measures

Name	Time	Method
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