Insertion Protocol of Convergent Transmucosal Design Implants
Italy25 participantsStarted 2024-02-14
Plain-language summary
The aim of this randomized clinical study is the evaluation of the peri-implant mucosal tissues and the marginal bone level, after positioning the transition shoulder from the intraosseous to the transmucosal portion, with an equicrestal position (at the level of the bone crest) or subcrestal (under the bone crest level).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \>18 years
* Absence of periodontal disease
* Full mouth plaque score and full mouth bleeding score less than or equal to 25%
* Sufficient bone height and width to place an implant in a prosthetically guided position without performing bone grafting procedures
* Stable occlusion
Exclusion Criteria:
* Smokers (more than 10 cigarettes a day)
* Medical conditions that contraindicate implant surgery
* Pregnant and breastfeeding patients
* Patients with a history of therapy with bisphosphonates or biologics
* Patients undergoing chemotherapy or radiation therapy of the head and neck
* Decompensated diabetes
* Severe bruxism
* Poor oral hygiene or uncooperative patients (incomplete data collection or failure to attend scheduled check-up appointments)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Peri-implant mucosa health and condition in terms of Pink Esthetic Score (PES).
Timeframe: 6-12 months
2
Peri-implant mucosa health and condition in terms of Plaque Index (PI).
Timeframe: 6-12 months
3
Peri-implant mucosa health and condition in terms of Bleeding Index (BI)
Timeframe: 6-12 months
4
Peri-implant bone health and condition in terms of change in marginal bone level (MBL)