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

Peri-Implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05945836
• Other study ID #: peri-implant/cement
• Status: Completed
• Start date: October 29, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: July 2023
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Peri-implant Mucositis
• Peri-Implantitis

Locations

Country	Name	City	State
Italy	Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Spatial position of submucosal cement	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	The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.