Non-Surgical Treatment of Peri-implantitis with Systemic Azithromycin or Placebo

NCT06715150 | Not Yet Recruiting Phase 4

• 2 other identifiers: USC77/2024Self founding
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the change in probing depth in patients with peri-implantitis, assessing the influence of systemic antibiotic (azithromycin) adjunctive to non-surgical treatment at 12 months. The secondary objective is to assess clinical, radiographic, microbiological, and systemic changes at 3, 6, and 12 months. This study is designed as a placebo-controlled, randomized, triple-blind clinical trial in subjects diagnosed with peri-implantitis. The treatment will consist of debridement of the implant surface and curettage of the pocket epithelium. The control group will receive placebo (1 placebo tablet per day for 3 days), and the test group will receive systemic azithromycin 500 mg per day for 3 days (1 tablet of 500 mg azithromycin per day for 3 days).

Conditions

Peri-implantitis

Keywords

Non-surgical treatment; Azithromycin; Systemic antibiotic

Outcome Measures

Primary Outcomes (1)

• Change in probing depth

  The change in probing depth (quantitative dependent variable) at 12 months will be measured in millimeters as the distance from the mucosal margin to the bottom of the peri-implant pocket, using a millimetric CP15 UNC Hu-Friedy probe. The change in probing depth will also be measured at 3 and 6 months.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (18)

• Recession

  From enrollment to the end of treatment at 12 months

• Clinical attachment level

  From enrollment to the end of treatment at 12 months

• Bleeding index

  From enrollment to the end of treatment at 12 months

• Plaque index

  From enrollment to the end of treatment at 12 months

• Width of the keratinized mucosa

  From enrollment to the end of treatment at 12 months

Study Arms (2)

Azithromycin 500 mg

ACTIVE COMPARATOR

Systemic antibiotic: Azithromycin 500 mg every 24 hours for 3 days

Drug: Azithromcyin

Placebo

PLACEBO COMPARATOR

Same shape, size and dosage as test

Other: Placebo

Interventions

Azithromcyin DRUG

Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.

Azithromycin 500 mg

Placebo OTHER

Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.

Placebo

Eligibility Criteria

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

You may qualify if:

• older than 18 years;
• absence of systemic pathology contraindicating treatment;
• presence of at least 1 implant diagnosed with peri-implantitis: presence of bleeding on probing, probing depth ≥6 mm, and radiographic bone level ≥3 mm apical to the most coronal portion of the intraosseous part of the implant;
• absence of implant mobility;
• patients without periodontitis or with treated periodontitis;
• patients who understand the treatment and are willing to comply with it by providing written informed consent.

You may not qualify if:

• smokers ≥10 cigarettes/day;
• diabetic patients (HbA1c level ≥6,5%);
• pregnant or breastfeeding women;
• use of antibiotics, corticosteroids, and/or immunosuppressive treatment in the 3 months prior to the start of the study;
• allergy to azithromycin;
• patients with a history of bisphosphonate treatment;
• chronic consumption of non-steroidal anti-inflammatory drugs;
• bone loss exceeding the apex of the implant;
• prosthesis that does not allow access to peri-implantitis treatment

Sponsors & Collaborators

• University of Santiago de Compostela: lead

Study Sites (1)

Department of Surgery and Medical-Surgical Specialties, Teaching and Research Unit in Periodontology. Faculty of Medicine and Dentistry, University of Santiago de Compostela.

Santiago de Compostela, A Coruña, 15782, Spain

Location

Related Publications (7)

• Orlandi M, Pranno N, Patel V, Papi P, Di Murro B, Pompa G, Polimeni A, Letizia C, Suvan J, D'Aiuto F. Peri-implant diseases and systemic inflammation: A preliminary analysis from a cross-sectional survey of patients with hypertension. J Periodontol. 2024 Jun;95(6):525-534. doi: 10.1002/JPER.21-0338. Epub 2024 May 14.

  PMID: 38742572 BACKGROUND

• Blanco C, Linares A, Dopico J, Pico A, Sobrino T, Leira Y, Blanco J. Peri-implantitis, systemic inflammation, and dyslipidemia: a cross-sectional biochemical study. J Periodontal Implant Sci. 2021 Oct;51(5):342-351. doi: 10.5051/jpis.2100920046.

  PMID: 34713995 BACKGROUND

• Linares A, Pico A, Blanco C, Blanco J. Adjunctive Systemic Metronidazole to Nonsurgical Therapy of Peri-implantitis with Intrabony Defects: A Retrospective Case Series Study. Int J Oral Maxillofac Implants. 2019 Sep/Oct;34(5):1237-1245. doi: 10.11607/jomi.7343.

  PMID: 31528867 BACKGROUND

• Renvert S, Lessem J, Dahlen G, Renvert H, Lindahl C. Mechanical and repeated antimicrobial therapy using a local drug delivery system in the treatment of peri-implantitis: a randomized clinical trial. J Periodontol. 2008 May;79(5):836-44. doi: 10.1902/jop.2008.070347.

  PMID: 18454662 BACKGROUND

• Linares A, Sanz-Sanchez I, Dopico J, Molina A, Blanco J, Montero E. Efficacy of adjunctive measures in the non-surgical treatment of peri-implantitis: A systematic review. J Clin Periodontol. 2023 Jun;50 Suppl 26:224-243. doi: 10.1111/jcpe.13821. Epub 2023 May 4.

  PMID: 37143407 BACKGROUND

• Estefania-Fresco R, Garcia-de-la-Fuente AM, Egana-Fernandez-Valderrama A, Bravo M, Aguirre-Zorzano LA. One-year results of a nonsurgical treatment protocol for peri-implantitis. A retrospective case series. Clin Oral Implants Res. 2019 Jul;30(7):702-712. doi: 10.1111/clr.13456. Epub 2019 Jun 1.

  PMID: 31090974 BACKGROUND

• Blanco C, Pico A, Dopico J, Gandara P, Blanco J, Linares A. Adjunctive benefits of systemic metronidazole on non-surgical treatment of peri-implantitis. A randomized placebo-controlled clinical trial. J Clin Periodontol. 2022 Jan;49(1):15-27. doi: 10.1111/jcpe.13564. Epub 2021 Oct 28.

  PMID: 34713471 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Juan Blanco Carrión

  Universidade de Santiago de Compostela

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Liñares González

CONTACT

+34 626492454; antonio@antoniolinares.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: December 4, 2024
• Study Start: January 10, 2025
• Primary Completion: January 10, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)