The Effect of Preoperative Antibiotics on Peri-implant Healing

NCT04280406 | Unknown Phase 1 DMC

• 1 other identifier: CERC-20-001-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: In order to minimize postoperative morbidity and failures of dental implant therapy, several antibiotic regimens have been proposed in the literature. However, the extensive use of antibiotics in health care has been debated due to the adverse effects and bacterial resistance. Furthermore, the impact of preoperative antibiotics on peri-implant bone level is still not clear. Objectives: The primary objective of this study will be to assess whether giving preoperative antibiotics (azithromycin 500mg) after implant placement over 7 days will influence peri-implant crestal bone levels after 4 months in healthy patients undergoing platform-switched implant placement. The secondary objectives will be to evaluate postoperative pain severity, surgery-associated morbidities, and 1-year implant survival rate. Methods: Fifty individuals will be recruited in a double-masked 2-arm randomized clinical trial. Participants in the intervention group will receive 500mg of azithromycin 1 hour before implant placement. Participants in the control group will take one placebo 1 hour preoperatively. The changes in mesial and distal crestal bone level (primary outcome) will be measured at baseline and 4-month follow-up using standardized periapical radiographs. Pain severity and surgery-associated morbidities (secondary outcomes) will be evaluated by clinical examinations and self-administered questionnaires. Implant survival rate will be assessed at the 1-year follow-up. Descriptive and bivariate analyses will be used to analyze the data. A P value ≤ 0.05 will be considered statistically significant. Clinical relevance: This study will be the first placebo-controlled double-blinded randomized clinical trial studying the effect of preoperative azithromycin on radiographical, clinical and patient-based outcomes after implant surgery. This type of design will reduce as much as possible the risk of bias and increasing the quality of evidence. The results from this study might help provide guidelines for clinicians that will optimize implant survival rate while decreasing antibiotics exposure to patients undergoing straightforward implant surgery.

Conditions

Dental Implant Failed

Keywords

dental implants; antibiotics; bone; pain

Outcome Measures

Primary Outcomes (1)

• peri-implant crestal bone change

  variations in mm of the alveolar bone around each implant

  4 months, 1 year

Secondary Outcomes (24)

• pain severity

  preop and daily for 1 week

• interferences with daily activities

  daily for 1 week

• postoperative morbidities A

  1 week, 4 months, 1 year

• postoperative morbidities B

  1 week, 4 months, 1 year

• postoperative morbidities F

  4 months, 1 year

Study Arms (2)

Test

ACTIVE COMPARATOR

\- 500mg of azithromycin one hour before implant placement

Drug: Azithromycin

control

PLACEBO COMPARATOR

\- identical placebo one hour before implant placement

Drug: Placebo oral tablet

Interventions

Azithromycin DRUG

azithromycin 500mg one hour before implant placement

Test

Placebo oral tablet DRUG

identical placebo one hour before implant placement

control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Periodontally healthy remaining dentition or presenting with mild gingivitis with adequate oral hygiene.
• Presence of a partially edentulous alveolar ridge that is planned to be restored with no more than 2 implants.
• To have 1 or 2 implants restored with a crown or fixed bridge.
• Presence of a non-infected site.
• Presence of enough bone and soft tissue for the implant to be placed without additional bone augmentation in a 1-stage approach (with healing abutment).
• Implants 6 mm long or longer.
• Subjects able and willing to provide written informed consent and comply with study procedures.

You may not qualify if:

• Subjects taking regular analgesics or antidepressants.
• Smoking 10 cigarettes/cigars or more per day.
• Marijuana smokers.
• Use of vaping devices or e-cigarettes
• Drug abuse.
• Completely edentulous individuals.
• Pregnant and nursing women.
• Allergies to macrolides, and/or non-steroidal anti-inflammatory analgesics.
• Active peptic ulcers or susceptibility to peptic ulcers.
• Any systemic or local immunodeficiency.
• Any blood coagulation impairment or taking anticoagulants (ex.: Coumadin).
• Presence of uncontrolled periodontitis or poor oral hygiene.
• Presence of any acute oral infection.
• Presence of uncontrolled diabetes or other systemic diseases.
• Previous radiation therapy in the head and neck area.

Sponsors & Collaborators

• Université de Montréal: lead
• Centre de Recherche du Centre Hospitalier de l'Université de Montréal: collaborator

Study Sites (1)

Université de Montréal - Faculty of Dentistry - Dental clinics

Montreal, Quebec, H3T 1J4, Canada

RECRUITING

Related Publications (12)

• Adell R. Tissue integrated prostheses in clinical dentistry. Int Dent J. 1985 Dec;35(4):259-65.

  PMID: 3912327 BACKGROUND

• Ireland RS, Palmer NO, Lindenmeyer A, Mills N. An investigation of antibiotic prophylaxis in implant practice in the UK. Br Dent J. 2012 Oct;213(8):E14. doi: 10.1038/sj.bdj.2012.960.

  PMID: 23099724 BACKGROUND

• Deeb GR, Soung GY, Best AM, Laskin DM. Antibiotic Prescribing Habits of Oral and Maxillofacial Surgeons in Conjunction With Routine Dental Implant Placement. J Oral Maxillofac Surg. 2015 Oct;73(10):1926-31. doi: 10.1016/j.joms.2015.05.024. Epub 2015 Jun 6.

  PMID: 26101074 BACKGROUND

• Braun RS, Chambrone L, Khouly I. Prophylactic antibiotic regimens in dental implant failure: A systematic review and meta-analysis. J Am Dent Assoc. 2019 Jun;150(6):e61-e91. doi: 10.1016/j.adaj.2018.10.015. Epub 2019 Apr 20.

  PMID: 31010572 BACKGROUND

• Esposito M, Grusovin MG, Worthington HV. Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications. Cochrane Database Syst Rev. 2013 Jul 31;2013(7):CD004152. doi: 10.1002/14651858.CD004152.pub4.

  PMID: 23904048 BACKGROUND

• Macy E, Contreras R. Health care use and serious infection prevalence associated with penicillin "allergy" in hospitalized patients: A cohort study. J Allergy Clin Immunol. 2014 Mar;133(3):790-6. doi: 10.1016/j.jaci.2013.09.021. Epub 2013 Nov 1.

  PMID: 24188976 BACKGROUND

• Miller RS, Wongsrichanalai C, Buathong N, McDaniel P, Walsh DS, Knirsch C, Ohrt C. Effective treatment of uncomplicated Plasmodium falciparum malaria with azithromycin-quinine combinations: a randomized, dose-ranging study. Am J Trop Med Hyg. 2006 Mar;74(3):401-6.

  PMID: 16525097 BACKGROUND

• Noedl H, Krudsood S, Chalermratana K, Silachamroon U, Leowattana W, Tangpukdee N, Looareesuwan S, Miller RS, Fukuda M, Jongsakul K, Sriwichai S, Rowan J, Bhattacharyya H, Ohrt C, Knirsch C. Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults: a randomized, phase 2 clinical trial in Thailand. Clin Infect Dis. 2006 Nov 15;43(10):1264-71. doi: 10.1086/508175. Epub 2006 Oct 12.

  PMID: 17051490 BACKGROUND

• Gomi K, Yashima A, Iino F, Kanazashi M, Nagano T, Shibukawa N, Ohshima T, Maeda N, Arai T. Drug concentration in inflamed periodontal tissues after systemically administered azithromycin. J Periodontol. 2007 May;78(5):918-23. doi: 10.1902/jop.2007.060246.

  PMID: 17470027 BACKGROUND

• Haffajee AD, Torresyap G, Socransky SS. Clinical changes following four different periodontal therapies for the treatment of chronic periodontitis: 1-year results. J Clin Periodontol. 2007 Mar;34(3):243-53. doi: 10.1111/j.1600-051X.2006.01040.x.

  PMID: 17309596 BACKGROUND

• Giamarellos-Bourboulis EJ. Macrolides beyond the conventional antimicrobials: a class of potent immunomodulators. Int J Antimicrob Agents. 2008 Jan;31(1):12-20. doi: 10.1016/j.ijantimicag.2007.08.001. Epub 2007 Nov 1.

  PMID: 17935949 BACKGROUND

• Tamaoki J, Kadota J, Takizawa H. Clinical implications of the immunomodulatory effects of macrolides. Am J Med. 2004 Nov 8;117 Suppl 9A:5S-11S. doi: 10.1016/j.amjmed.2004.07.023.

  PMID: 15586558 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Robert Durand, DMD, MS

  Université de Montréal

  PRINCIPAL INVESTIGATOR

• Intissar Abbaoui, DDS

  Université de Montréal

  STUDY DIRECTOR

Central Study Contacts

Robert Durand, DMD, MS

CONTACT

514-343-7464; robert.durand@umontreal.ca

Ryma Kabir, DMD, MSc

CONTACT

514-343-6111; ryma.kabir@umontreal.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: double-masked parallel arm randomized clinical trial

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 21, 2020
• Study Start: February 25, 2020
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)