Resective Surgical Treatment of Peri-implantitis.

NCT04337645 | Unknown

• 1 other identifier: 22101980
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical treatment of peri-implantitis can be regenerative or resective, depending on defect configuration. The aim of resective therapy of peri-implantitis is to reduce the severity of soft tissue inflammation and stabilize crestal bone levels whilst reducing probing depths.This will be a multicenter randomized controlled trial in which two resective peri-implantitis protocols will be assessed. The aim of this trial is to compare a resective approach in the surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline) with a resective approach combined with implantoplasty.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• probing depth

  measured distance in milimeters from the mucosal margin to the bottom of the probeable pocket (mm).

  18 months

Study Arms (2)

Test group

EXPERIMENTAL

resective surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline) combined with implantoplasty

Procedure: surgical treatment of peri-implantitis

Control group

ACTIVE COMPARATOR

resective surgical treatment of peri-implantitis (decontamination performed with titanium brushes and sterile saline)

Procedure: surgical treatment of peri-implantitis

Interventions

surgical treatment of peri-implantitis PROCEDURE

resective surgical treatment of peri-implantitis

Control group; Test group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• · Patients \>18 years old, able to provide consent and willing to undergo study procedures.
• Implants in function for at least 1 year.
• Patients with implant-supported partial/full jaw restorations having at least one implant diagnosed with peri-implantitis (probing pocket depth \[PPD\] ≥6mm, bleeding/suppuration on probing \[BoP/SoP+\] and marginal bone loss \>2 mm compared to a previous radiographic examination or marginal bone level \>3 mm (Berglundh et al. 2018)
• Patients with suprabony defects and intrabony defects up to 3mm in depth
• Retrievability of prosthetic reconstructions prior the surgical treatment (i.e. screw-retained restorations or cement-retained restorations which can easily be removed prior to all study visits)
• According to classification by Monje (Monje, 2019), implants presenting Class II, eventually Class IIIa and Class IIIb
• No implant mobility
• No evidence of occlusal overload
• Satisfactory oral hygiene level (FMPS\<25%) and periodontal health or localized periodontal inflammation (FMBS\<30%)
• Treated periodontal disease with adequate periodontal supportive therapy

You may not qualify if:

• · Patients unable or unwilling to comply with study procedures and study visits.
• Pregnant or nursing women
• Local conditions that may interfere with surgical treatment (non-treated periodontal disease, acute infections, carious lesions, etc.)
• Compromised systemic health preventing the patient from attending study visits or representing a contraindication for surgical treatment
• Patients with uncontrolled systemic conditions which may affect healing (i.e. diabetes mellitus). Diabetic patients will have to document their level of metabolic control by means of HbA1c and will only be included when HbA1c\<7%.
• Patients smoking more than 5 cigarettes per day (self-reported)
• Patients taking medications known to interfere with gingival or bone metabolism (e.g. calcium channel blockers, bisphosphonates).

Sponsors & Collaborators

• University of Belgrade: lead
• George Eastman Dental Hospital, Italy: collaborator

Study Sites (1)

Iva Milinkovic

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor

Model Details: Two treatment modalities will be applied. Test group will be treated bu resective approach combined with implantoplastry, whilst control group will be treated by resective approach alone. Randomization will be performed by means of randomisation envelopes.

Study Record Dates

• First Submitted: April 4, 2020
• First Posted: April 8, 2020
• Study Start: September 15, 2020
• Primary Completion: September 15, 2023
• Study Completion: December 15, 2023
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

SE (1)