Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

Peri-Implantitis Clinical Trial

Official title:

Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131567
• Other study ID #: 18102021
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: November 2024

Study information

• Verified date: January 2024
• Source: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
• Contact: Mamen Tome Rincon, DH
• Phone: +34924203045
• Email: mtome[@]periocicom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: November 2024
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion criteria

• All patients in age of 18 to 80, non-smokers

• With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.

• Peri-implantitis defined according to the EFP/AAP consensus meeting

• Combined defect configuration

Exclusion criteria:

• Pregnancy or lactation

• History of or current smokers

• Uncontrolled medical conditions,

• Cement-retained restoration

• Lacking keratinized mucosa (=2mm) on the lingual or buccal implant sites.

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• Implantoplasty
Implantoplasty as surface decontamination method

Locations

Country	Name	City	State
Spain	Centro de Implantologia Cirugia Oral y Maxilofacial	Badajoz

Sponsors (1)

Lead Sponsor	Collaborator
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of disease resolution	pocket depth <6mm, no bleeding on probing, no suppuration, no progressive bone loss	12 months after surgery