Longitudinal Evaluation of Regenerative Treatment of Peri-implantitis Assited by Er,Cr:YSGG Laser: up to 10 Years Follow-up

NCT07104760 | Active Not Recruiting DMC

• 5 other identifiers: Guarulhos University2008/07154-5#001311368/2019-0314479/2023-6
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Peri-implantitis is a pathological condition characterized by the inflammation of peri-implant connective tissues and progressive alveolar bone loss. There is a global concern about the increasing prevalence of this disease, which may affect up to 43% of implants in function. This cohort study will evaluated the long term follow up of a randomized, controlled, double-blind placebo study that evaluated the regenerative treatment of peri-implant diseases with surgical debridement and Er,Cr:YSGG AG laser associated with systemic antibiotics. A total of 80 subjects with peri-implantitis (PD\>5mm, BoP and/or sup, bone loss \>3mm) will be treated reavluated after 10years follow-up. Clinical, radiographic, and microbiological parameters will be recorded at baseline and 120 months follow-up. The primary outcome variable of this trial was be the difference between groups for the change in clinical attachment level from baseline to 6 months. We did consider composite outcomes, although not as the primary outcome. We also aim to evaluate the number and percentage of patients (and implants) reaching the following clinical endpoint for treatment: Probing depth \< 5mm, absence of bleeding on probing and no further bone loss (Heitz-Mayfield and Mombelli, 2014). The secondary variables will be the differences between groups in PI, GI, BOP, SUP and PD and microbial profile.

Conditions

Peri-Implantitis and Peri-implant Mucositis; Peri-Implantitis and Systemic Inflammation

Keywords

peri-implantitis; surgical treatment

Outcome Measures

Primary Outcomes (2)

• Clinical Attachment Level

  CAL mm

  120 months

• CAL

  gain of 1mm CAL

  10 years

Study Arms (2)

laser + ATB

Laser-ATB

LAser_LPR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Systemically healthy volunteers with treated peri-implantitis will be selected from the Oral Implantology Clinic - UNG.

You may qualify if:

• subjects with peri-implantitis presence of bleeding and/or suppuration on gentle probing, probing depths (PD) ≥ 6 mm, and bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant (Berglundh et al. 2018); treated by one of the treatment groups

You may not qualify if:

• failed implants, subjects with pregnancy or oncological problems

Sponsors & Collaborators

• University of Guarulhos: lead

Study Sites (1)

Guarulhos University

Guarulhos, São Paulo, 07090-160, Brazil

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Jamil A Shibli, PhD

  University of Guarulhos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: July 29, 2025
• Primary Completion: November 1, 2025
• Study Completion (Estimated): October 10, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-07

Locations

BR (1)