Antibiotics Causing Adverse Effects in Therapeutic UseEarly Phase 1NCT04980170
Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure
A Early Phase 1 study testing Clindamycin 300 mg and Amoxicillin with Clavulanic Acid 635mg in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Jordan University Hospital at 1 site in Jordan.
Trial summary
Among patients receiving dental implants, does the choice of antibiotics reduce the frequency of early implant failure ? Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Antibiotics Causing Adverse Effects in Therapeutic Use
- What is being tested?
- Clindamycin 300 mg and Amoxicillin with Clavulanic Acid 635mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJordan
- Study dates
- 1 Nov 2021to 1 Jun 2022
- Phase
- Early Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of a partial edentulous or edentulous alveolar ridge.
- Presence of a tooth or several teeth regarded as non-restorable with the intention of immediate implant placement.
- Periodontally healthy remaining dentition.
- Presence of a non-infected surgical site.
- Presence of enough bone and soft tissue for the implant to be placed without additional augmentation procedures.
- Must be able to swallow tablets
Who cannot join
- Patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and a history of rheumatic fever.
- Patients with metabolic diseases such as type I or II diabetes mellitus.
- Patients with past and present neoplastic disease.
- Previous radiotherapy in the head and neck area.
- Immunosuppressed patients.
- Patients with blood coagulation impairment.
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- Patients with a history of systemic steroid medication or recent systemic antibiotic therapy.
- Pregnant and lactating women
- Patients with allergy to the antibiotic chosen.
Trial locations and contacts
1 site in 1 country.
Jordan1 site
The University of Jordan Hospital
Amman, 11492
Ahmad Hamdan, DDS, 00962796767991, AHMHAM86@HOTMAIL.COM
ASHRAF ABUKARAKI, PROFESSOR, 00962795638010, a.abukaraky@ju.edu.jo
About this study
Among patients receiving dental implants, does the choice of antibiotics reduce the frequency of early implant failure ?
Read the detailed description
The patients were selected in the implant assessment clinic from a population on the implant waiting list at the department of Maxillofacial surgery department , of Jordan University Hospital. Those consecutively assessed patients that complied with both the inclusion and the exclusion criteria and who had signed consent for participation in the study formed the study sample.
The following inclusion criteria were applied: • Presence of a partial edentulous or edentulous alveolar ridge. • Presence of a tooth or several teeth regarded as non-restorable with the intention of immediate implant placement. • Periodontally healthy remaining dentition. • Presence of a non-infected surgical site. • Presence of enough bone and soft tissue for the implant to be placed without additional augmentation procedures.
The following exclusion criteria were applied: • Patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and a history of rheumatic fever. • Patients with metabolic diseases such as type I or II diabetes mellitus. • Patients with past and present neoplastic disease. • Previous radiotherapy in the head and neck area. • Immunosuppressed patients. • Patients with blood coagulation impairment. • Patients with a history of systemic steroid medication or recent systemic antibiotic therapy. • Pregnant and lactating women • Patients with allergy to the antibiotic chosen Every patient that agreed to participate was randomly assigned to one of the following two groups: • First group - 625mg of AMOCLAN immediately postoperatively, three times a day for 5 days. • Secondl group - 600mg of CLINDAMYCIN immediately postoperatively, three times a day for 5 days. Consecutively treated patients received consecutive numbers correlating with the number of an envelope. This envelope contained either the 625mg Amoclan, or 600mg Clindamycin An independent person administered the antibiotic Neither the surgeon nor the patient knew which has been taken to ensure a double-blind approach One Professor in MaxFAx surgery was the operator One implant typr used: Blue Sky Bio, USA Implants were placed according to the manufacturers guidelines using standard surgical procedures. The local anaesthetic used was Articaine 4% with adrenaline 1 : 100,000.
Following adequate local anaesthesia, a mucoperiosteal flap was raised with or without one or two relieving incisions as determined by the local anatomy, including availability of bone, presence of neighbouring tooth roots and aesthetics. Osteotomies were then carried out under copious saline irrigation. Implants were then placed with a view to obtaining good primary stability. A decision was then made placing a cover screw and opting for a two stage approach . Closure of the surgical site with either resorbable or non-resorbable sutures was then performed ensuring tension free closure of the flaps.
The patient was personally instructed and handed out standardised forms on post-operative care. Patients were advised on the use of post-operative pain medication. To minimise the influence of independent variables, all patients were instructed to use paracetamol 500 mg tablets as required to a maximum of 4 g/day and Ibuprofen 400mg tablets to a maximum of 2000mg. Patients were advised to remain on a soft diet for the first post-operative week. Patients were instructed to use a chlorhexidine 0.2% mouthwash 4-5 times daily for the first postoperative week.
Recordings of osseointegration failure or success were recorded three months post-operatively or at 2nd stage surgery. Post-operative swelling was recorded on the 7th days.
- Being tested
- Clindamycin 300 mg, Amoxicillin with Clavulanic Acid 635mg
- Keywords
- Effect of antiobiotic presctibed on early deental implant failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin 300 mgDrug
Also called Clinacin
patients will be given clindamycin 300 mg twice daily for 5 days after dental implant
Amoxicillin with Clavulanic Acid 635mgDrug
Also called Augmentin
patients will be given Amoxicillin with Clavulanic Acid 635mg, three times daily for 5 days after dental implant
| Study group | Role | What they receive |
|---|---|---|
| clindamycin group | Experimental | Patients who take Clindamycin after Dental implants Receives: Drug: Clindamycin 300 mg |
| Amoxicillin With Clavulanic Acid group | Experimental | Patients who take Amoxicillin With Clavulanic Acid after Dental implants Receives: Drug: Amoxicillin with Clavulanic Acid 635mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early failure of osseointegration of dental implants
Failure of osseointegration is defined as having ANY ONE of the following during the first three months of implant placement.
- implant mobility: Measured using two metal instruments moving against each other.
- Acute surgical site infection: presence of erythema, swelling, pain, discharge at the site of implant.
- Radiographic Bone Loss >50% of implant length: measured using calibrated digital tool on peri-apical radiograph.
- Pain on function: measured using a verbal analogue scale (VAS). Patients were asked to describe the amount of pain they felt by giving a number from 0 to 10, where 0 represented not feeling any sort of pain and 10 represented the maximum pain they could imagine.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Nov 2021 (estimated)
- Primary completion15 Mar 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Antibiotics Causing Adverse Effects in Therapeutic UseStudies 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
- Early Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jordan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Hamdan, Jordan University Hospital
- Investigators
- ASHRAF ABUKARAKI, PROFESSOR, Study director, Jordan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04980170
- Sponsor's protocol ID
- JordanUH
- Status last verified
- Jul 2021
- First submitted
- 9 Jun 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual data will not be shared. But the final results of anonomysed individuals will be shared
Publications
Malm MO, Jemt T, Stenport VF. Patient factors related to early implant failures in the edentulous jaw: A large retrospective case-control study. Clin Implant Dent Relat Res. 2021 Jun;23(3):466-476. doi: 10.1111/cid.13009. Epub 2021 May 17.
PubMed 33999522Malm MO, Jemt T, Stenport V. Early Implant Failures in Edentulous Patients: A Multivariable Regression Analysis of 4615 Consecutively Treated Jaws. A Retrospective Study. J Prosthodont. 2018 Dec;27(9):803-812. doi: 10.1111/jopr.12985. Epub 2018 Oct 29.
PubMed 30307086De Bruyn H, Raes S, Ostman PO, Cosyn J. Immediate loading in partially and completely edentulous jaws: a review of the literature with clinical guidelines. Periodontol 2000. 2014 Oct;66(1):153-87. doi: 10.1111/prd.12040.
PubMed 25123767Baqain ZH, Moqbel WY, Sawair FA. Early dental implant failure: risk factors. Br J Oral Maxillofac Surg. 2012 Apr;50(3):239-43. doi: 10.1016/j.bjoms.2011.04.074. Epub 2011 May 25.
PubMed 21612850
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure
- ClinicalTrials.gov ID
- NCT04980170
- Acronym / sponsor ID
- JordanUH
- Keywords
- Effect of antiobiotic presctibed on early deental implant failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Jordan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 15 Mar 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 28 Jul 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.
Among patients receiving dental implants, does the choice of antibiotics reduce the frequency of early implant failure ?
Detailed description
The patients were selected in the implant assessment clinic from a population on the implant waiting list at the department of Maxillofacial surgery department , of Jordan University Hospital. Those consecutively assessed patients that complied with both the inclusion and the exclusion criteria and who had signed consent for participation in the study formed the study sample.
The following inclusion criteria were applied: • Presence of a partial edentulous or edentulous alveolar ridge. • Presence of a tooth or several teeth regarded as non-restorable with the intention of immediate implant placement. • Periodontally healthy remaining dentition. • Presence of a non-infected surgical site. • Presence of enough bone and soft tissue for the implant to be placed without additional augmentation procedures.
The following exclusion criteria were applied: • Patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and a history of rheumatic fever. • Patients with metabolic diseases such as type I or II diabetes mellitus. • Patients with past and present neoplastic disease. • Previous radiotherapy in the head and neck area. • Immunosuppressed patients. • Patients with blood coagulation impairment. • Patients with a history of systemic steroid medication or recent systemic antibiotic therapy. • Pregnant and lactating women • Patients with allergy to the antibiotic chosen Every patient that agreed to participate was randomly assigned to one of the following two groups: • First group - 625mg of AMOCLAN immediately postoperatively, three times a day for 5 days. • Secondl group - 600mg of CLINDAMYCIN immediately postoperatively, three times a day for 5 days. Consecutively treated patients received consecutive numbers correlating with the number of an envelope. This envelope contained either the 625mg Amoclan, or 600mg Clindamycin An independent person administered the antibiotic Neither the surgeon nor the patient knew which has been taken to ensure a double-blind approach One Professor in MaxFAx surgery was the operator One implant typr used: Blue Sky Bio, USA Implants were placed according to the manufacturers guidelines using standard surgical procedures. The local anaesthetic used was Articaine 4% with adrenaline 1 : 100,000.
Following adequate local anaesthesia, a mucoperiosteal flap was raised with or without one or two relieving incisions as determined by the local anatomy, including availability of bone, presence of neighbouring tooth roots and aesthetics. Osteotomies were then carried out under copious saline irrigation. Implants were then placed with a view to obtaining good primary stability. A decision was then made placing a cover screw and opting for a two stage approach . Closure of the surgical site with either resorbable or non-resorbable sutures was then performed ensuring tension free closure of the flaps.
The patient was personally instructed and handed out standardised forms on post-operative care. Patients were advised on the use of post-operative pain medication. To minimise the influence of independent variables, all patients were instructed to use paracetamol 500 mg tablets as required to a maximum of 4 g/day and Ibuprofen 400mg tablets to a maximum of 2000mg. Patients were advised to remain on a soft diet for the first post-operative week. Patients were instructed to use a chlorhexidine 0.2% mouthwash 4-5 times daily for the first postoperative week.
Recordings of osseointegration failure or success were recorded three months post-operatively or at 2nd stage surgery. Post-operative swelling was recorded on the 7th days.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clindamycin group | Experimental | Drug: Clindamycin 300 mgPatients who take Clindamycin after Dental implants |
| Amoxicillin With Clavulanic Acid group | Experimental | Drug: Amoxicillin with Clavulanic Acid 635mgPatients who take Amoxicillin With Clavulanic Acid after Dental implants |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Presence of a partial edentulous or edentulous alveolar ridge.
- Presence of a tooth or several teeth regarded as non-restorable with the intention of immediate implant placement.
- Periodontally healthy remaining dentition.
- Presence of a non-infected surgical site.
- Presence of enough bone and soft tissue for the implant to be placed without additional augmentation procedures.
Key exclusion criteria (9 listed)
- Patients with medical conditions that required antibiotic premedication such as prosthetic heart valve replacement, skeletal joint replacement, previous history of infective endocarditis and a history of rheumatic fever.
- Patients with metabolic diseases such as type I or II diabetes mellitus.
- Patients with past and present neoplastic disease.
- Previous radiotherapy in the head and neck area.
- Immunosuppressed patients.
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 |
|---|---|---|
| Clindamycin 300 mgAlso: Clinacinpatients will be given clindamycin 300 mg twice daily for 5 days after dental implant | Drug | clindamycin group |
| Amoxicillin with Clavulanic Acid 635mgAlso: Augmentinpatients will be given Amoxicillin with Clavulanic Acid 635mg, three times daily for 5 days after dental implant | Drug | Amoxicillin With Clavulanic Acid group |
Primary outcome
Early failure of osseointegration of dental implants
Time frame: 3 months
Failure of osseointegration is defined as having ANY ONE of the following during the first three months of implant placement. 1. implant mobility: Measured using two metal instruments moving against each other. 2. Acute surgical site infection: presence of erythema, swelling, pain, discharge at the site of implant. 3. Radiographic Bone Loss >50% of implant length: measured using calibrated digital tool on peri-apical radiograph. 4. Pain on function: measured using a verbal analogue scale (VAS). Patients were asked to describe the amount of pain they felt by giving a number from 0 to 10, where 0 represented not feeling any sort of pain and 10 represented the maximum pain they could imagine.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Results publication: PubMed 33999522Malm MO, Jemt T, Stenport VF. Patient factors related to early implant failures in the edentulous jaw: A large retrospective case-control study. Clin Implant Dent Relat Res. 2021 Jun;23(3):466-476. doi: 10.1111/cid.13009. Epub 2021 May 17.
- Results publication: PubMed 30307086Malm MO, Jemt T, Stenport V. Early Implant Failures in Edentulous Patients: A Multivariable Regression Analysis of 4615 Consecutively Treated Jaws. A Retrospective Study. J Prosthodont. 2018 Dec;27(9):803-812. doi: 10.1111/jopr.12985. Epub 2018 Oct 29.
- Results publication: PubMed 25123767De Bruyn H, Raes S, Ostman PO, Cosyn J. Immediate loading in partially and completely edentulous jaws: a review of the literature with clinical guidelines. Periodontol 2000. 2014 Oct;66(1):153-87. doi: 10.1111/prd.12040.
- Results publication: PubMed 21612850Baqain ZH, Moqbel WY, Sawair FA. Early dental implant failure: risk factors. Br J Oral Maxillofac Surg. 2012 Apr;50(3):239-43. doi: 10.1016/j.bjoms.2011.04.074. Epub 2011 May 25.
- Individual participant dataSharing planned: No. Individual data will not be shared. But the final results of anonomysed individuals will be shared
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.
ASHRAF ABUKARAKI, PROFESSOR study director
Jordan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clindamycin 300 mg and Amoxicillin with Clavulanic Acid 635mg in people with Antibiotics Causing Adverse Effects in Therapeutic Use, run by Jordan University Hospital at 1 site in Jordan.
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 6 inclusion and 9 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 28 Jul 2021. 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 Jordan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Ahmad Hamdan (00962796767991, ahmham86@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early failure of osseointegration of dental implants (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04980170, which also lists 4 linked publications.
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 28 Jul 2021.