Peri-implant MucositisNCT05945836
Peri-implant Disease and Prosthetic Cement: Cross-sectional Study
An observational study of Peri-implant Mucositis and Peri-Implantitis, run by University of Bologna at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implant Mucositis, Peri-Implantitis
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 29 Oct 2018to 19 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- neuromotor pathologies or morphological-dysfunctional alterations
Trial locations and contacts
1 site in 1 country.
Italy1 site
Alma Mater Studiorum - University of Bologna, Department of Biomedical and Neuromotor Sciences, School of Dentistry - Division of Periodontology and Implantology.
Bologna, 40120
About this study
Official title: Excess Cement and Peri-implant Disease: A Cross-sectional Clinical Endoscopic 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.
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- Dental implants, Peri-implant diseases, Excess cement, Implant prosthesis, Endoscopy
- Medical subject headings
- Peri-Implantitis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
Secondary outcomes (1)
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
Measured: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start29 Oct 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implant MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Montevecchi, University of Bologna
- Investigators
- Marco Montevecchi, DDS, Study chair, Alma Mater Studiorum - University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945836
- Sponsor's protocol ID
- peri-implant/cement
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2023
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available when the research will be published
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Excess Cement and Peri-implant Disease: A Cross-sectional Clinical Endoscopic Study
- ClinicalTrials.gov ID
- NCT05945836
- Acronym / sponsor ID
- peri-implant/cement
- Conditions
- Peri-implant Mucositis, Peri-Implantitis
- Keywords
- Dental implants, Peri-implant diseases, Excess cement, Implant prosthesis, Endoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Study start
- 29 Oct 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- neuromotor pathologies or morphological-dysfunctional alterations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Spatial position of submucosal cement
Time frame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Individual participant dataSharing planned: Yes. Data will be available when the research will be published
Related trials for Peri-implant Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruiting
Adjunctive Diode Laser Therapy for Peri-Implant Mucositis
Peri-implant Mucositis
Not yet recruitingObservational study
Short Versus Standard Dental Implants: Clinical and Biomarker Outcomes
Peri-Implant Mucositis
RecruitingObservational study
Impact of Smoking on Immune Responses in Peri-implant Health and Disease
Peri-Implant Health, Peri Implant Mucositis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Montevecchi, DDS study chair
Alma Mater Studiorum - University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implant Mucositis and Peri-Implantitis, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of submucosal cement (time frame: The analysis was conducted during the endoscopic examination between October 29, 2018, and July 19, 2019.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2023.