NCT04856319

Brief Summary

There is no consensus on antibiotic prophylaxis in dental implant applications, and its necessity is controversial. Current reports on antibiotic use are insufficient. Also, other than antibiotic prophylaxis, data that may affect the post-operative situation such as the patient's gender, age, smoking, duration of surgery, length of the operation field, flap design have not been evaluated comprehensively. This study aims to evaluate post-operative complications, implant success, and implant stability in 50 individuals: preoperative single dose of 2 g amoxicillin + clavulanic acid (25) and placebo (25).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

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

April 12, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

April 12, 2021

Last Update Submit

August 29, 2023

Conditions

Tooth Loss

Keywords

Dental ImplantsAntibiotic Prophylaxis

Outcome Measures

Primary Outcomes (7)

  • Baseline implant stability / osseointegration

    Periotest M

    Baseline

  • 10th day implant stability / osseointegration

    Periotest M

    10th day

  • 1st month implant stability / osseointegration

    Periotest M

    1st month

  • Final implant stability / osseointegration

    Periotest M

    3rd month

  • Radiographic bone loss

    The distance of the bone crest to the implant shoulder

    3rd month

  • Early healing index (Wachtel et al)

    Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)

    10th day

  • Early healing index (Wachtel et al)

    Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)

    1st month

Secondary Outcomes (4)

  • Operation duration

    Baseline

  • Painkiller (0-3 days)

    Baseline - 3rd day

  • Painkiller (3-10 days)

    3rd day - 10th day

  • Operation zone length

    Baseline

Study Arms (2)

Prophylaxis

ACTIVE COMPARATOR

2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery

Procedure: Dental implant placementDrug: Antibiotic prophylaxis

Placebo

PLACEBO COMPARATOR

placebo 1 hour prior to dental implant surgery

Procedure: Dental implant placementOther: Placebo

Interventions

Dental implant placementPROCEDURE

Insertion of not more than two dental implants at the same area

PlaceboProphylaxis
Antibiotic prophylaxisDRUG

Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery

Prophylaxis
PlaceboOTHER

Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery

Placebo

Eligibility Criteria

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

You may qualify if:

  • Tooth loss

You may not qualify if:

  • Systemic disease
  • Lactation/pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tooth Loss

Interventions

Antibiotic Prophylaxis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

ChemopreventionDrug TherapyTherapeuticsPremedication

Study Officials

  • Mustafa Yılmaz, PhD

    Biruni University, assistant professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Yılmaz, PhD

CONTACT

+905337129952myilmaz@biruni.edu.tr

Burcu Karaduman, PhD

CONTACT

bkaraduman@biruni.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
The patients and the surgeon will be masked if antibiotics or placebo were used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 23, 2021

Study Start

September 1, 2022

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

All IPD will be shared

Shared Documents
STUDY PROTOCOL
Time Frame
Starting one year after the publication
Access Criteria
All the collected data will be accessible to researchers conducting meta-analysis or examining the reliability of our study

Locations

TU(1)