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

NCT ID: NCT05925179

Last Updated: 2023-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tooth Diseases Tooth Wear

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

antibiotic prophylaxis

per os 2 g augmentin one hour prior to surgery

Group Type EXPERIMENTAL

Surgical crown lengthening

Intervention Type PROCEDURE

Surgical clinical crown lengthening with bone excision

Augmentin

Intervention Type DRUG

Pre-operative antibiotic prophylaxis (2 g Augmentin)

placebo control

per os placebo one hour prior to surgery

Group Type PLACEBO_COMPARATOR

Surgical crown lengthening

Intervention Type PROCEDURE

Surgical clinical crown lengthening with bone excision

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Surgical crown lengthening

Surgical clinical crown lengthening with bone excision

Intervention Type PROCEDURE

Augmentin

Pre-operative antibiotic prophylaxis (2 g Augmentin)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biruni University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mustafa YILMAZ

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Mustafa YILMAZ, PhD, DDS

Role: CONTACT

+902124440276

Ayse Ege Selman, DDS

Role: CONTACT

+902124440276

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 30324746 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Antibiotics crown lengthening

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Dietary Supplements and Periodontal Wound Healing
NCT02315222 UNKNOWN PHASE2/PHASE3
AUGMENTIN™ in Dental Infections
NCT02141217 COMPLETED PHASE4
The Treatment of Periodontal Diseases
NCT01318928 UNKNOWN PHASE4