Peri-implant Disease and Prosthetic Cement: Cross-sectional Study

The main objective of the present clinical study project, of a cross-sectional observational nature, is to evaluate the presence of submucosal cement residues through endoscopic visualization in clinical situations with peri-implant disease.

The secondary objective is to investigate the potential correlation between the severity of the pathological condition and the spatial position of cement residues in relation to the implant-prosthetic unit.

For each subject, the following data were collected: gender, age, periodontal history, smoking habits, reasons for implant rehabilitation (trauma, caries, periodontitis, agenesis, other), the position of the implant in the oral cavity, elapsed time between prosthetic rehabilitation and pathological condition. If the deposit was recognized as cement residue, its presence was recorded, and the anatomical position of the cement residue (mesial, distal, lingual/palatal, vestibular) and the spatial position of cement residues in relation to the implant-prosthetic unit were collected.

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Key information

Conditions

Peri-implant Mucositis Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.

Bologna, 40120, Italy

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

at least one single-implant with cemented restoration and clinical-radiographic signs of peri-implant disease
patients with previous periodontitis had to have a healthy but reduced periodontium

Exclusion criteria

neuromotor pathologies or morphological-dysfunctional alterations

Treatment and study plan

Primary outcomes

Prevalence of submucosal cement

Time frame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.

A clinical examination of the submarginal implant area was performed using endoscopic techniques (DV2, Dental View, Irvine, CA). The analysis was conducted in an atraumatic manner, and local anesthesia infiltration (2% Mepivacaine with 1:100,000 adrenaline) was administered only upon patient request. During the endoscopic investigation, once a deposit was identified, its consistency and adhesion were assessed using water irrigation or, less frequently, a probe. Only for solid deposits, a differential analysis between calculus and cementum was conducted. Cementum was identified by its characteristic white reflectivity, in contrast to subgingival calculus, which appeared yellow or brown, depending on the intensity and distance of the incident light beam.

Secondary outcomes

Spatial position of submucosal cement

Time frame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
If the deposit was recognized as cement residue, its presence was recorded, and the following clinical data were collected:
- Distance between mucosal margin and prosthetic closure margin at the site of the cement residue: MM-PM = Mucosal Margin - Prosthetic Margin
- Distance between prosthetic closure margin and implant platform at the site of the cement residue: PM-IP = Prosthetic Margin - Implant Platform
- Distance between the most apical portion of the cement residue and implant platform: AC-IP = Apical Cement - Implant Platform

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Registry information

Official study title

Excess Cement and Peri-implant Disease: A Cross-sectional Clinical Endoscopic Study

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Jul 14, 2023
Registry last updated: Jul 19, 2023

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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Completed