Dental Implant TherapyNCT05827211
The Usefulness of Antibiotics in Smokers Receiving Dental Implants
A study testing Antibiotic group and Non-Antibiotic group in people with Dental Implant Therapy, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
Trial summary
Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis. Read more about this study
- Who is it for?
- Ages 19 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Therapy
- What is being tested?
- Antibiotic group and Non-Antibiotic group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- 2 Apr 2023to 10 Jun 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 19 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- smoker
- in need of dental implant therapy
- above 18 years of age
Who cannot join
- allergy to doxycycline,
- need for endocarditis prophylaxis,
- any systemic or local immunodeficiency,
- uncontrolled diabetes mellitus,
- previous radiation therapy in the head and neck area
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis.
Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.
- Conditions
- Dental Implant Therapy
- Being tested
- Antibiotic group, Non-Antibiotic group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic groupProcedure or surgery
Also called Dental implant insertion + Antibiotics
Partially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics
Non-Antibiotic groupProcedure or surgery
Also called Dental implant insertion + Placebo
Partially or fully edentulous smoker patients will be treated by dental implants and will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Participants in this group will receive Doxycycline 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. Receives: Procedure: Antibiotic group |
| Control group | Placebo comparator | Participants in this group will receive a placebo 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. Receives: Procedure: Non-Antibiotic group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of post-operative infection
signs of infection (fever > 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start2 Apr 2023
- Primary completion30 Apr 2023
- Study completion10 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant TherapyStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arab American University (Palestine)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abu-Ta'a, Arab American University (Palestine)
- Investigators
- Mahmoud Abu-Ta'a, Principal investigator, Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827211
- Sponsor's protocol ID
- Antibiotics
- Status last verified
- Jul 2023
- First submitted
- 31 Mar 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Asepsis During Periodontal Surgery Involving Oral Implants and the Usefulness of Antibiotics: a Prospective, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05827211
- Acronym / sponsor ID
- Antibiotics
- Conditions
- Dental Implant Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Arab American University (Palestine)University, hospital or other
- Study start
- 2 Apr 2023 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 10 Jun 2023 (actual)
- First posted
- 24 Apr 2023 (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.
Objectives: This randomized clinical trial will compare the usefulness of pre- and postoperative antibiotics while strict asepsis will be followed during periodontal surgery in smokers diagnosed with Stage III Grade C Generalized Periodontitis.
Material and Methods: Two groups of 40 consecutive patients each with fully or partially edentulous jaws will be enrolled. Antibiotics group (GrAB+): will receive oral doxycycline 200 mg, 1 h pre-operatively and 100 mg g for 9 days post-operatively. Non-antibiotics group (GrAB- ): will receive a placebo (no antibiotics). Bacterial samples will be taken from the peri-oral skin before and at the end of the surgery. In 12 patients in each group, samples will also be taken from the nares. A visual analogue scale will evaluate symptoms of infection/ inflammation by both the patient and the periodontist at suture removal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Procedure: Antibiotic groupParticipants in this group will receive Doxycycline 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. |
| Control group | Placebo comparator | Procedure: Non-Antibiotic groupParticipants in this group will receive a placebo 200 mg 1 h pre-op and 100 mg for 9 days post-op in combination with dental implant therapy. |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- smoker
- in need of dental implant therapy
- above 18 years of age
Key exclusion criteria (5 listed)
- allergy to doxycycline,
- need for endocarditis prophylaxis,
- any systemic or local immunodeficiency,
- uncontrolled diabetes mellitus,
- previous radiation therapy in the head and neck area
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 |
|---|---|---|
| Antibiotic groupAlso: Dental implant insertion + AntibioticsPartially or fully edentulous smoker patients will be treated by dental implants and will receive systemic antibiotics | Procedure or surgery | Test group |
| Non-Antibiotic groupAlso: Dental implant insertion + PlaceboPartially or fully edentulous smoker patients will be treated by dental implants and will receive placebo | Procedure or surgery | Control group |
Primary outcome
Rate of post-operative infection
Time frame: 7 days
signs of infection (fever > 38 degrees celsius, spontaneous bleeding, pus, swelling, etc.) post-operatively will be checked at suture removal
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Abu-Ta'a principal investigator
Department of Dental sciences, Faculty of Graduate Studies, Arab American University (AAUP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic group and Non-Antibiotic group in people with Dental Implant Therapy, run by Arab American University (Palestine) at 1 site in Palestinian Territories.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jul 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 Palestinian Territories. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of post-operative infection (time frame: 7 days). 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 20 Jul 2023.