Back to resultsThe Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Primary Purpose
Tooth Loss
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Dental implant placement
Antibiotic prophylaxis
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Loss focused on measuring Dental Implants, Antibiotic Prophylaxis
Eligibility Criteria
Inclusion Criteria:
- Tooth loss
Exclusion Criteria:
- Systemic disease
- Lactation/pregnancy
Sites / Locations
- Biruni UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Prophylaxis
Placebo
Arm Description
2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
placebo 1 hour prior to dental implant surgery
Outcomes
Primary Outcome Measures
Baseline implant stability / osseointegration
Periotest M
10th day implant stability / osseointegration
Periotest M
1st month implant stability / osseointegration
Periotest M
Final implant stability / osseointegration
Periotest M
Radiographic bone loss
The distance of the bone crest to the implant shoulder
Early healing index (Wachtel et al)
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Early healing index (Wachtel et al)
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Secondary Outcome Measures
Operation duration
Duration between the first incision and the last suture
Painkiller (0-3 days)
500 mg paracetamol, the count of the painkillers the subject used
Painkiller (3-10 days)
500 mg paracetamol, the count of the painkillers the subject used
Operation zone length
(mm) the crestal incision and vertical incision (if applied) length
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04856319
Brief Title
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Official Title
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Biruni University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Loss
Keywords
Dental Implants, Antibiotic Prophylaxis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The patients and the surgeon will be masked if antibiotics or placebo were used.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prophylaxis
Arm Type
Active Comparator
Arm Description
2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo 1 hour prior to dental implant surgery
Intervention Type
Procedure
Intervention Name(s)
Dental implant placement
Intervention Description
Insertion of not more than two dental implants at the same area
Intervention Type
Drug
Intervention Name(s)
Antibiotic prophylaxis
Intervention Description
Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
Primary Outcome Measure Information:
Title
Baseline implant stability / osseointegration
Description
Periotest M
Time Frame
Baseline
Title
10th day implant stability / osseointegration
Description
Periotest M
Time Frame
10th day
Title
1st month implant stability / osseointegration
Description
Periotest M
Time Frame
1st month
Title
Final implant stability / osseointegration
Description
Periotest M
Time Frame
3rd month
Title
Radiographic bone loss
Description
The distance of the bone crest to the implant shoulder
Time Frame
3rd month
Title
Early healing index (Wachtel et al)
Description
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Time Frame
10th day
Title
Early healing index (Wachtel et al)
Description
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Time Frame
1st month
Secondary Outcome Measure Information:
Title
Operation duration
Description
Duration between the first incision and the last suture
Time Frame
Baseline
Title
Painkiller (0-3 days)
Description
500 mg paracetamol, the count of the painkillers the subject used
Time Frame
Baseline - 3rd day
Title
Painkiller (3-10 days)
Description
500 mg paracetamol, the count of the painkillers the subject used
Time Frame
3rd day - 10th day
Title
Operation zone length
Description
(mm) the crestal incision and vertical incision (if applied) length
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Tooth loss
Exclusion Criteria:
Systemic disease
Lactation/pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mustafa Yılmaz, PhD
Phone
+905337129952
Email
myilmaz@biruni.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Burcu Karaduman, PhD
Email
bkaraduman@biruni.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mustafa Yılmaz, PhD
Organizational Affiliation
Biruni University, assistant professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Biruni University
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mustafa YILMAZ, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD will be shared
IPD Sharing Time Frame
Starting one year after the publication
IPD Sharing Access Criteria
All the collected data will be accessible to researchers conducting meta-analysis or examining the reliability of our study
Learn more about this trial
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
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