Long-term Stability of Peri-implantitis Treatments: a 3-year Clinical Evaluation

Sponsor
Ramón Pons Calabuig
Study ID
NCT07208643
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Study Details

This prospective study will include patients previously enrolled in the PER-ECL-2019-05 trial who attend the Department of Periodontology (CUO) for maintenance therapy or treatment of periodontal and/or peri-implant diseases, provided they meet the inclusion criteria. Initially, 36 patients with advanced peri-implantitis were enrolled in a randomized clinical trial evaluating the clinical, radiographic and patient-related outcomes of reconstructive therapy following a non-surgical phase of peri-implantitis treatment compared to non-surgical treatment alone (PER-ECL-2019-05) (10). At the study conclusion 34 patients were re-evaluated and 2 patients were excluded from the study (10). In the original study, adult patients presenting at least one titanium implant diagnosed with peri-implantitis were identified among patients referred to the Department of Periodontology of UIC between January 2020 and October 2022. Peri-implantitis was diagnosed following the case definition of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions (11) that is, PPD ≥ 6 mm combined with bleeding on probing (BOP) and/or suppuration (SUP), together with progressive bone loss in relation to the radiographic bone level assessment. In those cases where initial radiograph was unavailable, the definition of a peri-implantitis case was based on radiographic evidence of bone level ≥3 mm apical to the most coronal portion of the intra-osseous part of the implant (12). At the outset of the original study, participants were randomly assigned to one of two groups: The first group received only non-surgical therapy for peri-implantitis, while the second group underwent a non-surgical phase followed by reconstructive surgical treatment. This design allowed for direct comparison of the clinical, radiographic, and patient-centered outcomes between the two treatment modalities. Both groups were managed and evaluated according to standardized protocols, ensuring consistency and reliability of the results at 12 months . Patients who have not returned to the Department will be contacted by telephone and invited to participate through the academic office. At 36 months, a single follow-up will be carried out including: A detailed clinical examination. A standardized radiographic assessment.

Key Dates

Start date
Apr 1, 2026
Status verified
Apr 2026
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
34 participants (estimated)

Arms

  • Arm: 'atients previously enrolled in the PER-ECL-2019-05 trial
    Initially, 36 patients with advanced peri-implantitis were enrolled in a randomized clinical trial evaluating the clinical, radiographic and patient-related outcomes of reconstructive therapy following a non-surgical phase of peri-implantitis treatment compared to non-surgical treatment alone (PER-ECL-2019-05) .At the study conclusion 34 patients were re-evaluated and 2 patients were excluded from the study

Primary Outcome Measure

ecurrence/progression of peri-implantitis [ Time Frame: 3 years ]

Central Contacts

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