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

Sponsor

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain (Other)

Overall Status

Recruiting

CT.gov ID

NCT06131567

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Peri-Implantitis	Procedure: Implantoplasty	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized clinical trials with paired number of subjectsRandomized clinical trials with paired number of subjects

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Actual Primary Completion Date :

Nov 1, 2021

Anticipated Study Completion Date :

Nov 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Implantoplasty Implantoplasty to all the implant surface	Procedure: Implantoplasty Implantoplasty as surface decontamination method
Active Comparator: Implantoplasty on the supracrestal component Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide	Procedure: Implantoplasty Implantoplasty as surface decontamination method

Arm

Intervention/Treatment

Experimental: Implantoplasty

Implantoplasty to all the implant surface

Procedure: Implantoplasty

Implantoplasty as surface decontamination method

Active Comparator: Implantoplasty on the supracrestal component

Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide

Procedure: Implantoplasty

Implantoplasty as surface decontamination method

Outcome Measures

Primary Outcome Measures

Disease resolution [12 months after surgery]
pocket depth <6mm, no bleeding on probing, no suppuration, no progressive bone loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro de Implantologia Cirugia Oral y Maxilofacial	Badajoz		Spain	06011

Sponsors and Collaborators

Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alberto Monje, Alberto Monje Correa, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

ClinicalTrials.gov Identifier:

NCT06131567

Other Study ID Numbers:

18102021

First Posted:

Nov 14, 2023

Last Update Posted:

Nov 14, 2023

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Peri-Implantitis

Study Results

No Results Posted as of Nov 14, 2023