Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure

Among patients receiving dental implants, does the choice of antibiotics reduce the frequency of early implant failure ?

Study Overview

• Status: Not yet recruiting
• Conditions: Antibiotics Causing Adverse Effects in Therapeutic Use
• Intervention / Treatment: Drug: Clindamycin 300 mg; Drug: Amoxicillin with Clavulanic Acid 635mg

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Ahmad Hamdan; Phone Number: 00962796767991; Email: ahmham86@hotmail.com
• Study Contact Backup: Name: ASHRAF ABUKARAKI, PROFESSOR; Phone Number: 00962795638010; Email: a.abukaraky@ju.edu.jo

Study Locations

• Jordan
  • Amman, Jordan, 11492
    • The University of Jordan Hospital
    • Contact: ASHRAF ABUKARAKI, PROFESSOR; Phone Number: 00962795638010; Email: a.abukaraky@ju.edu.jo
    • Contact: Ahmad Hamdan, DDS; Phone Number: 00962796767991; Email: AHMHAM86@HOTMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: clindamycin group; Patients who take Clindamycin after Dental implants	Drug: Clindamycin 300 mg; patients will be given clindamycin 300 mg twice daily for 5 days after dental implant; Other Names: Clinacin
Experimental: Amoxicillin With Clavulanic Acid group; Patients who take Amoxicillin With Clavulanic Acid after Dental implants	Drug: Amoxicillin with Clavulanic Acid 635mg; patients will be given Amoxicillin with Clavulanic Acid 635mg, three times daily for 5 days after dental implant; Other Names: Augmentin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Jordan University Hospital
• Investigators: Study Director: ASHRAF ABUKARAKI, PROFESSOR, Jordan University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): March 15, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Effect of antiobiotic presctibed on early deental implant failure
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Protein Synthesis Inhibitors; beta-Lactamase Inhibitors; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
• Other Study ID Numbers: JordanUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual data will not be shared. But the final results of anonomysed individuals will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No