Timing of Success Evaluation After Flapless Treatment of Peri-Implantitis

NCT07844642 | Not Yet Recruiting

• 1 other identifier: 39/2026
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is an inflammatory disease around dental implants that causes progressive loss of the bone supporting the implant. Current clinical guidelines recommend treating it first with a non-surgical approach and then checking treatment success, usually between 6 and 12 weeks later. However, it is not known whether this is the best time to check the results, since no previous studies have compared different follow-up time points. This study will follow patients with peri-implantitis who receive the same non-surgical, flapless treatment. Their implants will be checked at five different times after treatment (6 and 12 weeks, and 6, 9, and 12 months) to see how the clinical outcome changes over time. The main goal is to find out how treatment success evolves at these different time points, and whether the results seen early (at 6 weeks) match the final results seen at 12 months

Conditions

Peri-implantitis

Keywords

Non-surgical treatment; Flapless treatment; Treatment success; Re-evaluation timing

Outcome Measures

Primary Outcomes (1)

• Clinical Success Following Flapless Treatment of Peri-Implantitis

  Clinical success, recorded dichotomously (success/no success), assessed at six sites per implant. An implant is classified as a clinical success when probing depth (PD) is ≤5 mm at all six sites, bleeding on probing is present at, at most, one site and presents as an isolated spot rather than a line or profuse bleeding, and suppuration is absent at all sites.

  6 weeks, 12 weeks, 6 months, 9 months, and 12 months after treatment

Secondary Outcomes (29)

• Age (Years)

  Baseline (T0)

• Sex (Male/Female)

  Baseline (T0)

• Smoking Status (Never Smoker/Former Smoker/Current Smoker)

  Baseline (T0)

• Periodontal Diagnosis (Stage I-IV; Grade A-C)

  Baseline (T0)

• Arch (Maxilla/Mandible)

  Baseline (T0)

Study Arms (1)

Flapless treatment

Procedure: Flapless non-surgical treatment of peri-implantitis

Interventions

Flapless non-surgical treatment of peri-implantitis PROCEDURE

Non-surgical flapless treatment consisting of oral hygiene motivation and instructions, removal of the implant-supported prosthesis when possible, modification of the emergence profile when indicated, supra- and submucosal mechanical debridement using ultrasonic devices with periodontal tips and steel curettes, removal of granulation tissue, and curettage of the peri-implant mucosa. Followed by chlorhexidine gel twice daily for 15 days and systemic antibiotic therapy (metronidazole 500 mg three times daily for 7 days, or azithromycin 500 mg once daily for 3 days in case of allergy/contraindication)

Flapless treatment

Eligibility Criteria

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

Study Population

Adult patients with at least one dental implant in function for at least 12 months, diagnosed with peri-implantitis according to the 2017 World Workshop criteria, treated at the Hospital Odontològic Universitat de Barcelona.

You may qualify if:

• Patients aged 18 years or older.
• General health status compatible with dental treatment (ASA I-II).
• Ability to understand the study, sign the informed consent form, and comply with the follow-up protocol.
• Presence of one or more dental implants in function for at least 12 months, placed at any center, regardless of connection type or the presence of platform switching.
• Screw-retained implant-supported prostheses (single-unit, partial, or complete).
• Presence of at least one implant diagnosed with peri-implantitis, according to the criteria of the 2017 Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.

You may not qualify if:

• Refusal to participate in the study or inability to provide informed consent.
• Non-acceptance of the proposed treatment.
• Pregnancy or breastfeeding.
• Treatment with drugs or presence of diseases that may alter the healing of peri-implant tissues or interfere with the response to treatment (e.g., immunosuppressants, systemic corticosteroids at immunosuppressive doses, or treatment with antiresorptive or antiangiogenic agents).
• Implants restored with cemented prostheses.
• Implants with mobility or with radiographic bone loss exceeding 50%.
• Surgical or non-surgical peri-implant treatment of the affected implant within the previous 12 months.
• Systemic antibiotic treatment within the previous 3 months.

Sponsors & Collaborators

• University of Barcelona: lead

Study Sites (1)

Hospital Odontològic Universitat de Barcelona

L'Hospitalet de Llobregat, Barcelona, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: September 28, 2026

Record last verified: 2026-09

Locations

ES (1)