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

NCT04980170 | Unknown Early Phase 1

• 1 other identifier: JordanUH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antibiotics Causing Adverse Effects in Therapeutic Use

Keywords

Effect of antiobiotic presctibed on early deental implant failure

Outcome Measures

Primary Outcomes (1)

• 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. 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.

  3 months

Study Arms (2)

clindamycin group

EXPERIMENTAL

Patients who take Clindamycin after Dental implants

Drug: Clindamycin 300 mg

Amoxicillin With Clavulanic Acid group

EXPERIMENTAL

Patients who take Amoxicillin With Clavulanic Acid after Dental implants

Drug: Amoxicillin with Clavulanic Acid 635mg

Interventions

Clindamycin 300 mg DRUG

patients will be given clindamycin 300 mg twice daily for 5 days after dental implant

Also known as: Clinacin

clindamycin group

Amoxicillin with Clavulanic Acid 635mg DRUG

patients will be given Amoxicillin with Clavulanic Acid 635mg, three times daily for 5 days after dental implant

Also known as: Augmentin

Amoxicillin With Clavulanic Acid group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jordan University Hospital: lead

Study Sites (1)

The University of Jordan Hospital

Amman, 11492, Jordan

Location

Related Publications (4)

• 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.

  PMID: 33999522 RESULT

• 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.

  PMID: 30307086 RESULT

• 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.

  PMID: 25123767 RESULT

• 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.

  PMID: 21612850 RESULT

MeSH Terms

Interventions

Clindamycin; Amoxicillin; Clavulanic Acid; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Clavulanic Acids; Drug Combinations; Pharmaceutical Preparations

Study Officials

• ASHRAF ABUKARAKI, PROFESSOR

  Jordan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Ahmad Hamdan

CONTACT

00962796767991; ahmham86@hotmail.com

ASHRAF ABUKARAKI, PROFESSOR

CONTACT

00962795638010; a.abukaraky@ju.edu.jo

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral and Maxillofacial surgery resident

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: July 28, 2021
• Study Start: November 1, 2021
• Primary Completion: March 15, 2022
• Study Completion: June 1, 2022
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)