The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed Analysis

NCT03777449 | Completed DMC

• 1 other identifier: 18002909-12/2018
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

To study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters) Diagnosis of peri-implantitis requires:

• Presence of bleeding and/or suppuration on gentle probing.
• Increased probing depth compared to previous examinations.
• Presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling. In the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of:
• Presence of bleeding and/or suppuration on gentle probing.
• Probing depths of ≥6 mm.
• Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Morphology

  Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)

  6 months

Secondary Outcomes (1)

• Severity of the peri-implant bone loss

  6 months

Study Arms (3)

Vertical bone loss

Infra-osseous defects

Radiation: CBCT

Horizontal bone loss

Supra-osseous defects

Radiation: CBCT

Combined bone loss

Combined supra-osseous and infra-osseous defects

Interventions

CBCT RADIATION

Patients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one.

Horizontal bone loss; Vertical bone loss

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy partially/complete edentulous having previously received screw-retained implants for oral rehabilitation for ≥3 years.

You may qualify if:

• Male or female patients between 18 and 80 years of age
• Partial/complete edentulism missing one or more teeth and having it restored with implant-supported prosthesis
• No antibiotic in the last 2 months previous to examination
• \>3 year after prosthesis delivery

You may not qualify if:

• Uncontrolled systemic disease
• Cemented-retained restorations
• Patients with uncontrolled/active periodontal disease in need of periodontal treatment
• Pregnant patients
• Zygomatic implants
• Implants placed in regenerated/augmented bone
• Patients taking medications known to modify bone metabolism or known to have degenerative diseases of bone (hyperparathyroidism, osteoporosis), vitamin D, patients who had taken antibiotics, NSAIDS or corticosteroids for more than two weeks in the past 3 months before examination

Sponsors & Collaborators

• Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain: lead

Study Sites (1)

CICOM

Badajoz, 06001, Spain

Location

Related Publications (1)

• Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.

  PMID: 31087457 DERIVED

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2018
• First Posted: December 17, 2018
• Study Start: August 10, 2018
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

ES (1)