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

Biruni University

Status and phase: Not yet enrolling; Phase 4

Conditions: Tooth Wear; Tooth Diseases

Treatments: Procedure: Surgical crown lengthening; Drug: Augmentin

Study type: Interventional

Funder types: Other

Identifiers

NCT05925179

Antibiotics crown lengthening

Details and patient eligibility

About

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.

Enrollment: 28 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups, including a placebo group

antibiotic prophylaxis

Experimental group

Description:

per os 2 g augmentin one hour prior to surgery

Treatment:

Drug: Augmentin

Procedure: Surgical crown lengthening

placebo control

Placebo Comparator group

Description:

per os placebo one hour prior to surgery

Treatment:

Procedure: Surgical crown lengthening