Evaluation of Implantoplasty in the Treatment of Peri-Implantitis.

NCT06884475 | Active Not Recruiting DMC

• 1 other identifier: 83149424.7.0000.5418
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this longitudinal study is to evaluate the clinical impact of implantoplasty in the treatment of peri-implantitis, exploring the potential effect of removing compromised implants on periodontal health and its correlation with the presence of titanium particles in the crevicular fluid. In addition, we seek to investigate changes in the peri-implant microbiological profile before and after implantoplasty, allowing a more comprehensive understanding of the effects of this procedure at both the biological and clinical levels, considering microbiological factors and the relationship with titanium, inflammation and peri-implant health. Forty participants diagnosed with peri-implantitis will be selected (n = 20 in each group) to participate in the study. They will be randomly allocated into two groups, according to the treatment to be performed (implantoplasty group and surgical access group for scaling). Using a millimeter-diameter periodontal probe, the initial clinical parameters of patients with periodontal and peri-implant disease will be evaluated. Biofilm and crevicular fluid will then be collected using sterile paper cones from one implant of each patient in all groups at follow-up intervals of 1, 3 and 6 months for subsequent processing and evaluation of the data. The integration of these analyses aims to offer valuable insights to optimize peri-implantitis treatment strategies, aiming at the health and longevity of dental implants.

Conditions

Peri-Implantitis and Peri-implant Mucositis

Keywords

Peri-implantitis; Implantoplasty; Titanium; Immune response; Microbiota; Surgical access

Outcome Measures

Primary Outcomes (6)

• Clinical parameters before and after implantoplasty and compare them to surgical access without implantoplasty.

  Plaque index.

  Baseline; 1,3 and 6 months after procedure.

• Clinical parameters before and after implantoplasty and compare them to surgical access without implantoplasty.

  Bleeding on probing.

  Baseline; 1,3 and 6 months after procedure.

• Clinical parameters before and after implantoplasty and compare them to surgical access without implantoplasty.

  Probing depth.

  Baseline; 1,3 and 6 months after procedure.

• Clinical parameters before and after implantoplasty and compare them to surgical access without implantoplasty.

  Clinical insertion level.

  Baseline; 1,3 and 6 months after procedure.

• Quantity of titanium particles in the crevicular fluid before and after implantoplasty.

  Concentration of Titanium in the peri-implant environment.

  Baseline; 1,3 and 6 months after procedure.

• To characterize and compare the peri-implant microbiological profile before and after implantoplasty.

  Microbiome.

  Baseline; 1,3 and 6 months after procedure.

Secondary Outcomes (1)

• Correlation between the presence of titanium particles, microbiological profile and local inflammatory response.

  Baseline; 1,3 and 6 months after procedure.

Study Arms (2)

Implantoplasty: treatment of peri-implantitis.

EXPERIMENTAL

After patient selection, 20 individuals (chosen randomly) will be selected to receive treatment for Peri-implantitis with surgical access and implantoplasty.

Procedure: Implantoplasty

Surgical access: treatment of peri-implantitis.

EXPERIMENTAL

After patient selection, 20 individuals (chosen randomly) will be selected to receive treatment for peri-implantitis with surgical access and debridement without performing implantoplasty.

Procedure: Surgical access

Interventions

Surgical access PROCEDURE

Following clinical and radiographic examinations and thorough case planning, surgical procedures were performed under local anesthesia by a operator. After, anesthesia, only surgical access will be performed for debridement without implantoplasty of the affected dental implant.

Surgical access: treatment of peri-implantitis.

Implantoplasty PROCEDURE

Following clinical and radiographic examinations and thorough case planning, surgical procedures were performed under local anesthesia by a operator. After, anesthesia, surgical access will be performed for debridement and implantoplasty of the affected dental implant.

Implantoplasty: treatment of peri-implantitis.

Eligibility Criteria

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

You may not qualify if:

• The following conditions will also be excluded: Pregnancy or lactation; Use of antibiotic or anti-inflammatory medication in the 6 months prior to the study; Presence of systemic diseases that make the surgical procedure impossible; Periodontal treatment including subgingival instrumentation in the 6 weeks prior to the study; Chronic alcohol users; Previous periodontal surgeries in the region of interest; Oral pathologies in the region of interest.

Sponsors & Collaborators

• University of Campinas, Brazil: lead

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Minimally Invasive Surgical Procedures

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Renato Casarin, PhD

  University of Campinas, Brazil

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, supervisor responsible for research

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 19, 2025
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

BR (1)