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

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Study type

Observational

Primary location

CICOM

Badajoz, 06001, Spain

About this study

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

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Morphology

Time frame: 6 months

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

Secondary outcomes

Severity of the peri-implant bone loss

Time frame: 6 months

Distance in mm from the top of the implant down to the defect base

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Dec 17, 2018
Registry last updated: Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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