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

NCT05945836 | Completed

• 1 other identifier: peri-implant/cement
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Peri-implant Mucositis; Peri-Implantitis

Keywords

Dental implants; Peri-implant diseases; Excess cement; Implant prosthesis; Endoscopy

Outcome Measures

Primary Outcomes (1)

• Prevalence of submucosal cement

  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.

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

Secondary Outcomes (1)

• Spatial position of submucosal cement

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutively, all subjects over 18 years of age presenting at least one cemented single-implant restoration with clinical and radiographic signs of peri-implant disease were included in the study.

You may qualify if:

• 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

You may not qualify if:

• neuromotor pathologies or morphological-dysfunctional alterations

Sponsors & Collaborators

• University of Bologna: lead

Study Sites (1)

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

Bologna, 40120, Italy

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Marco Montevecchi, DDS

  Alma Mater Studiorum - University of Bologna

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 14, 2023
• Study Start: October 29, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: July 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available when the research will be published
• Access Criteria: On request to the main investigator

Locations

IT (1)