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

NCT07208643 | Recruiting

• 2 other identifiers: PER-ECL-2025-03Long-term stability of peri-im
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 2

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.

Conditions

Peri-implantitis

Keywords

Peri-implantitis; Non-surgical therapy; Reconstructive therapy; Maintenance therapy; Prospective study; flapless treatment

Outcome Measures

Primary Outcomes (2)

• ecurrence/progression of peri-implantitis

  The primary outcome was recurrence/progression of peri-implantitis between years 1 and 3, defined as any of the following events: (a) bone loss \>1.0 mm, (b) surgical retreatment, (c) implant removal/loss )

  3 years

• recurrence/progression of peri-implantitis

  The primary outcome was recurrence/progression of peri-implantitis between years 1 and 3, defined as any of the following events: (a) bone loss \>1.0 mm, (b) surgical retreatment, (c) implant removal/loss )

  3 years

Study Arms (1)

'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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patiens previously enrolled in the randomized clinical trial PER-ECL-2019-05, which included 36 patients with advanced peri-implantitis and treated with non surgical therapy or surgical therapy + reconstructive therapy

You may qualify if:

• \. Patiens previously enrolled in the randomized clinical trial PER-ECL-2019-05, which included 36 patients with advanced peri-implantitis.
• \. Completion of the original study protocol, including either reconstructive surgical therapy following a non-surgical phase or non-surgical therapy alone.
• Signed informed consent for participation in the follow-up assessment.

You may not qualify if:

• Did not complete the original clinical trial protocol (PER-ECL-2019-05) or withdrew before final evaluation.
• Had the implant removed due to complications unrelated to peri-implantitis progression.
• 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.
• Are currently undergoing antibiotic or antiresorptive therapy (e.g., bisphosphonates) that could interfere with bone metabolism.
• 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.

Sponsors & Collaborators

• Ramón Pons Calabuig: lead

Study Sites (2)

Hospital Universitari General de Catalunya

Sant Cugat del Vallès, Bacelona, 08195, Spain

RECRUITING

Clinica Universitaria ́̀ d'Odontologia - UIC Barcelona at the Periodontology Department

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Related Publications (1)

• Soldini MC, Pons R, Nart J, Monje A, Carrio N, Valles C. Reconstructive Therapy of Peri-Implantitis Following Non-Surgical Treatment: A Randomized Controlled Trial. Clin Implant Dent Relat Res. 2025 Apr;27(2):e70024. doi: 10.1111/cid.70024. Erratum In: Clin Implant Dent Relat Res. 2025 Jun;27(3):e70058. doi: 10.1111/cid.70058.

  PMID: 40183214 RESULT

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• CRISTINA VALLES CS VALLES, PhD

  Universitat Internacional de Catalunya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

cristina valles cv cristina valles DDS, MSc, PhD, PhD

CONTACT

93 504 20 00; cristinavallveg@uic.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: dds ms

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: October 6, 2025
• Study Start: April 1, 2026
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

ES (2)