The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success

Sponsor
Biruni University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04856319
Collaborator
(none)
50
1
2
15
3.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Procedure: Dental implant placement
  • Drug: Antibiotic prophylaxis
  • Other: Placebo
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
The patients and the surgeon will be masked if antibiotics or placebo were used.
Primary Purpose:
Treatment
Official Title:
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Prophylaxis

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

Procedure: Dental implant placement
Insertion of not more than two dental implants at the same area

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

Placebo Comparator: Placebo

placebo 1 hour prior to dental implant surgery

Procedure: Dental implant placement
Insertion of not more than two dental implants at the same area

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

Outcome Measures

Primary Outcome Measures

  1. Baseline implant stability / osseointegration [Baseline]

    Periotest M

  2. 10th day implant stability / osseointegration [10th day]

    Periotest M

  3. 1st month implant stability / osseointegration [1st month]

    Periotest M

  4. Final implant stability / osseointegration [3rd month]

    Periotest M

  5. Radiographic bone loss [3rd month]

    The distance of the bone crest to the implant shoulder

  6. Early healing index (Wachtel et al) [10th day]

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

  7. Early healing index (Wachtel et al) [1st month]

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

Secondary Outcome Measures

  1. Operation duration [Baseline]

    Duration between the first incision and the last suture

  2. Painkiller (0-3 days) [Baseline - 3rd day]

    500 mg paracetamol, the count of the painkillers the subject used

  3. Painkiller (3-10 days) [3rd day - 10th day]

    500 mg paracetamol, the count of the painkillers the subject used

  4. Operation zone length [Baseline]

    (mm) the crestal incision and vertical incision (if applied) length

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Tooth loss
Exclusion Criteria:
  • Systemic disease

  • Lactation/pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biruni University Istanbul Turkey

Sponsors and Collaborators

  • Biruni University

Investigators

  • Principal Investigator: Mustafa Yılmaz, PhD, Biruni University, assistant professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa YILMAZ, Assist Prof, Biruni University
ClinicalTrials.gov Identifier:
NCT04856319
Other Study ID Numbers:
  • Implant prophylaxis
First Posted:
Apr 23, 2021
Last Update Posted:
Feb 1, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mustafa YILMAZ, Assist Prof, Biruni University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 1, 2022