NCT05925179

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2023

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

July 19, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

June 21, 2023

Last Update Submit

July 18, 2023

Conditions

Tooth DiseasesTooth Wear

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

antibiotic prophylaxis

EXPERIMENTAL

per os 2 g augmentin one hour prior to surgery

Procedure: Surgical crown lengtheningDrug: Augmentin

placebo control

PLACEBO COMPARATOR

per os placebo one hour prior to surgery

Procedure: Surgical crown lengthening

Interventions

Surgical crown lengtheningPROCEDURE

Surgical clinical crown lengthening with bone excision

antibiotic prophylaxisplacebo control
AugmentinDRUG

Pre-operative antibiotic prophylaxis (2 g Augmentin)

antibiotic prophylaxis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 30324746BACKGROUND

MeSH Terms

Conditions

Tooth DiseasesTooth Wear

Interventions

Amoxicillin-Potassium Clavulanate Combination

Condition Hierarchy (Ancestors)

Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Clavulanic AcidClavulanic Acidsbeta-LactamsLactamsAmidesOrganic ChemicalsAmoxicillinAmpicillinPenicillin GPenicillinsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsDrug CombinationsPharmaceutical Preparations

Central Study Contacts

Mustafa YILMAZ, PhD, DDS

CONTACT

+902124440276myilmaz@biruni.edu.tr

Ayse Ege Selman, DDS

CONTACT

+902124440276aselman@biruni.edu.tr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 21, 2023

First Posted

June 29, 2023

Study Start

August 1, 2023

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

July 19, 2023

Record last verified: 2023-07