Tooth LossNCT04856319
The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
A study testing Dental implant placement and Antibiotic prophylaxis in people with Tooth Loss, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Dental implant placement and Antibiotic prophylaxis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Tooth loss
Who cannot join
- Systemic disease
- Lactation/pregnancy
Trial locations and contacts
1 site in 1 country.
Burcu Karaduman, PhD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Biruni University
Istanbul
Mustafa YILMAZ, PhD
About this study
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).
- Conditions
- Tooth Loss
- Being tested
- Dental implant placement, Antibiotic prophylaxis, Placebo
- Keywords
- Dental Implants, Antibiotic Prophylaxis
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
Insertion of not more than two dental implants at the same area
Antibiotic prophylaxisDrug
Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
PlaceboOther
Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
| Study group | Role | What they receive |
|---|---|---|
| Prophylaxis | Active comparator | 2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery Receives: Procedure: Dental implant placement; Drug: Antibiotic prophylaxis |
| Placebo | Placebo comparator | placebo 1 hour prior to dental implant surgery Receives: Procedure: Dental implant placement; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline implant stability / osseointegration
Periotest M
Measured: Baseline
10th day implant stability / osseointegration
Periotest M
Measured: 10th day
1st month implant stability / osseointegration
Periotest M
Measured: 1st month
Final implant stability / osseointegration
Periotest M
Measured: 3rd month
Radiographic bone loss
The distance of the bone crest to the implant shoulder
Measured: 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)
Measured: 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)
Measured: 1st month
Secondary outcomes (4)
Operation duration
Duration between the first incision and the last suture
Measured: Baseline
Painkiller (0-3 days)
500 mg paracetamol, the count of the painkillers the subject used
Measured: Baseline - 3rd day
Painkiller (3-10 days)
500 mg paracetamol, the count of the painkillers the subject used
Measured: 3rd day - 10th day
Operation zone length
(mm) the crestal incision and vertical incision (if applied) length
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start1 Sep 2022
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa YILMAZ, Biruni University
- Investigators
- Mustafa Yılmaz, PhD, Principal investigator, Biruni University, assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856319
- Sponsor's protocol ID
- Implant prophylaxis
- Status last verified
- Aug 2023
- First submitted
- 12 Apr 2021
- Last updated
- 30 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD will be shared
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-operative Single Dose Antibiotic Prophylaxis on the Post-operative Implant Success
- ClinicalTrials.gov ID
- NCT04856319
- Acronym / sponsor ID
- Implant prophylaxis
- Conditions
- Tooth Loss
- Keywords
- Dental Implants, Antibiotic Prophylaxis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prophylaxis | Active comparator | Procedure: Dental implant placement, Drug: Antibiotic prophylaxis2 g amoxicillin+clavulanic acid 1 hour prior to dental implant surgery |
| Placebo | Placebo comparator | Procedure: Dental implant placement, Other: Placeboplacebo 1 hour prior to dental implant surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Tooth loss
Key exclusion criteria (2 listed)
- Systemic disease
- Lactation/pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dental implant placementInsertion of not more than two dental implants at the same area | Procedure or surgery | Placebo, Prophylaxis |
| Antibiotic prophylaxisPer-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery | Drug | Prophylaxis |
| PlaceboPer-os placebo (inert polysaccharide) will be administered one hour prior to the surgery | Other | Placebo |
Primary outcome
Baseline implant stability / osseointegration
Time frame: Baseline
Periotest M
10th day implant stability / osseointegration
Time frame: 10th day
Periotest M
1st month implant stability / osseointegration
Time frame: 1st month
Periotest M
Final implant stability / osseointegration
Time frame: 3rd month
Periotest M
Radiographic bone loss
Time frame: 3rd month
The distance of the bone crest to the implant shoulder
Early healing index (Wachtel et al)
Time frame: 10th day
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
Early healing index (Wachtel et al)
Time frame: 1st month
Complete flap closure (1), fine fibrin line (2), fibrin clot (3), partial necrosis (4), complete necrosis (5)
4 secondary outcomes
Operation duration
Time frame: Baseline
Painkiller (0-3 days)
Time frame: Baseline - 3rd day
Painkiller (3-10 days)
Time frame: 3rd day - 10th day
Operation zone length
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: Yes. All IPD will be shared
Related trials for Tooth Loss
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burcu Karaduman, PhD contact
Mustafa Yılmaz, PhD principal investigator
Biruni University, assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement and Antibiotic prophylaxis in people with Tooth Loss, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mustafa Yılmaz, PhD (+905337129952, myilmaz@biruni.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Baseline implant stability / osseointegration (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.