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

Sponsor

University of Bologna (Other)

Overall Status

Completed

CT.gov ID

NCT05945836

Collaborator

(none)

Enrollment

Location

8.6

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peri-implant Mucositis Peri-Implantitis

Study Design

Study Type:

Observational

Actual Enrollment :

46 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Oct 29, 2018

Actual Primary Completion Date :

Jul 19, 2019

Actual Study Completion Date :

Jul 19, 2019

Outcome Measures

Primary Outcome Measures

Prevalence of submucosal cement [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 Outcome Measures

Spatial position of submucosal cement [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.	Bologna		Italy	40120