Clinical trial NCT04980170: Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure
Official title: Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
Keywords: Effect of antiobiotic presctibed on early deental implant failure
Lead sponsor: Jordan University Hospital
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Early failure of osseointegration of dental implants
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan Hospital
Study officials:
affiliation: Jordan University Hospital
name: ASHRAF ABUKARAKI, PROFESSOR
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Malm 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.
citation: De 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.
citation: Baqain 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.