Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation … (NCT05359549) | Clinical Trial Compass
CompletedNot Applicable
Dental Implant Treatment for Two Adjacent Teeth in the Maxillary Aesthetic Region: an Evaluation After 10 Years
Netherlands25 participantsStarted 2022-10-06
Plain-language summary
* Background Replacement of two missing adjacent teeth is considered a difficult treatment in implant dentistry and even more challenging if located in the anterior region due to aesthetic demands. As well peri-implant bone contour as soft tissue volume is compromised at start of the treatment and difficult to restore. The question is if this reconstruction will be stable in the longterm. Full-scale evaluation of adjacent implant placement with crown rehabilitation in the aesthetic region with a follow-up of at least 10 years is underreported in this field of implant dentistry.
* Main research question The aim of this observational study was to analyze peri-implant bone changes, mucosa levels, aesthetic ratings and patient-reported satisfaction with the maxillary aesthetic region following implant placement with crown restoration after a 10-years follow-up period.
* Design (including population, confounders/outcomes) The study design is an observational study of a group of patients with two missing adjacent teeth in the maxillary aesthetic region which was treated 10 years ago with dental implant placement and an implant-supported restorations.
Outcomes: primary outcome is the change in marginal peri-implant bone level 10 years after placing the definitive restoration. Secondary outcome measures will be implant and restoration survival and changes in interproximal peri-implant mucosa, midfacial peri-implant mucosal level , aesthetic outcome assessed by means of an objective index and patients' satisfaction using a questionnaire.
• Expected results Stable peri-implant bone levels, stable peri-implant soft tissue levels, high implant and restoration survival rate and satisfied patients.
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:
* Patients, having two missing teeth in the maxillary aesthetic region, referred to the department of Oral and Maxillofacial Surgery 10 years ago and treated with dental implant placement and implant-supported restorations. At the time of treatment:
* The patient was 18 years or older;
* The failing teeth were an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
* Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability \> 45 Ncm
* The implant site was free from infection;
* Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
* Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
* The patient was capable of understanding and giving informed consent.
Exclusion Criteria:
* • Medical and general contraindications for the surgical procedures;
* Presence of an active and uncontrolled periodontal disease;
* Bruxism;
* Smoking
* A history of local radiotherapy to the head and neck region.
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
Change in peri-implant marginal bone level
Timeframe: Comparison initial radiograph with radiograph after 10 years