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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05945836
Enrollment
46
Registered
2023-07-14
Start date
2018-10-29
Completion date
2019-07-19
Last updated
2023-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peri-Implantitis, Peri-implant Mucositis

Keywords

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

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.

Interventions

None listed

Sponsors

University of Bologna
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of submucosal cementThe 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

MeasureTime frameDescription
Spatial position of submucosal cementThe 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026