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

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

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.

Study Overview

• Status: Completed
• Conditions: Peri-Implantitis
• Intervention / Treatment: Radiation: CBCT

Detailed Description

Nowadays, several radiographic techniques are available to investigate the peri-implant bone morphology by two-dimensional radiographs such as panoramic radiography and intraoral radiography, or three-dimensional techniques such as computer tomography and cone beam computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization of bone beds; however, artifacts caused by the metallic character of implants could disguise information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The ex vivo studies (cadaver models), considering sensitivity and specificity reported good values for both circumferential and infrabony defects but lower for dehiscences (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for defect analysis in animal studies showed positive correlation with histology but tend to overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement is mainly dependent on the different configuration, location or size of the defect. and also by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.

Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

• Spain
  • Badajoz, Spain, 06001
    • CICOM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vertical bone loss; Infra-osseous defects	Radiation: CBCT; 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; Supra-osseous defects	Radiation: CBCT; 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.
Combined bone loss; Combined supra-osseous and infra-osseous defects

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morphology	Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of the peri-implant bone loss	Distance in mm from the top of the implant down to the defect base	6 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: December 14, 2018
• First Submitted That Met QC Criteria: December 14, 2018
• First Posted (Actual): December 17, 2018

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 27, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 18002909-12/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No