NCT07208643 Long-term Stability of Peri-implantitis Treatments: a 3-year Clinical Evaluation
| NCT ID | NCT07208643 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ramón Pons Calabuig |
| Condition | Peri-implantitis |
| Study Type | OBSERVATIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 34 participants in total. It began in 2026-04-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 1\. Patiens previously enrolled in the randomized clinical trial PER-ECL-2019-05, which included 36 patients with advanced peri-implantitis. 2\. Completion of the original study protocol, including either reconstructive surgical therapy following a non-surgical phase or non-surgical therapy alone. 3.Signed informed consent for participation in the follow-up assessment. Exclusion Criteria: * 1.Did not complete the original clinical trial protocol (PER-ECL-2019-05) or withdrew before final evaluation. 2.Had the implant removed due to complications unrelated to peri-implantitis progression. 3.Have developed systemic diseases or conditions (e.g., uncontrolled diabetes, immunosuppression, malignancy) that may affect periodontal or peri-implant tissue healing or confound clinical outcomes. 4.Are currently undergoing antibiotic or antiresorptive therapy (e.g., bisphosphonates) that could interfere with bone metabolism. 5.Are pregnant or breastfeeding at the time of the follow-up visit. 6.Are unwilling or unable to attend the clinical follow-up appointment or provide informed consent.
Contact & Investigator
CRISTINA VALLES CS VALLES, PhD
PRINCIPAL INVESTIGATOR
Universitat Internacional de Catalunya
Frequently Asked Questions
Who can join the NCT07208643 clinical trial?
This trial is open to participants of all sexes, studying Peri-implantitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07208643 currently recruiting?
Yes, NCT07208643 is actively recruiting participants. Contact the research team at cristinavallveg@uic.es for enrollment information.
Where is the NCT07208643 trial being conducted?
This trial is being conducted at Sant Cugat del Vallès, Spain, Sant Cugat del Vallès, Spain.
Who is sponsoring the NCT07208643 clinical trial?
NCT07208643 is sponsored by Ramón Pons Calabuig. The principal investigator is CRISTINA VALLES CS VALLES, PhD at Universitat Internacional de Catalunya. The trial plans to enroll 34 participants.