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

Biruni University28 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Tooth Diseases Tooth Wear

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: at 3 days

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

Time frame: at 10 days

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

Time frame: at 6 weeks

Central Contacts

Mustafa YILMAZ, PhD, DDS

CONTACT

+902124440276 myilmaz@biruni.edu.tr

Ayse Ege Selman, DDS

CONTACT

+902124440276 aselman@biruni.edu.tr