Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants: Two-piece Abu… (NCT05592821) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Radiographic Evaluation of Bone and Tissue Level Single Unit Implants: Two-piece Abutment Concept
Turkey (Türkiye)20 participantsStarted 2020-12-07
Plain-language summary
Dental implants have become one of the most common treatments used for the rehabilitation of lost teeth. The success rate of dental implant treatment is quite high. One of the criteria used for long-term implant success is the evaluation of radiographic marginal bone loss. Implants are used at the bone and tissue level in implant treatment. In this study, it was planned to use 20 implants of the same brand, with a single implant in the bilateral posterior regions in 10 patients.The study will be designed as split-mouth. The implant will be placed at the bone level with the same protocol in the two edentulous areas and the flap will be closed primarily. After 3 months, the substructure of the two-piece abutment concept system will be placed in a region during the healing head placement stage, and the bone level implant will be converted to the tissue level. A conventional healing cap will be placed in the other area. Periapical radiographs will be taken from the patients who participated in our study, as in all implant patients, during the pre-surgical planning phase and after implant placement. With the control periapical radiographs to be taken as a result of one-year follow-up, the marginal bone loss amount in the implants will be evaluated using soft-ware. Clinical measurements will be taken in all patients at the prosthetic loading session and 1 year after loading.
Who can participate
Age range
18 Years – 65 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:
* Being over 18 years old
* The patient does not have any systemic disease
* Implants are placed in the fully healed alveolar bone
* There is no need for horizontal and vertical augmentation in the area where the implant will be placed.
* Interocclusal distance greater than 7 mm
* The edentulous space is free-ended or the mesiodistal width in the interdental region is at least 6 mm
* Cooperative patients
* At least 9 mm of alveolar bone in the patient's mandible or maxilla in the area where the implant will be placed
Exclusion Criteria:
* Pregnant and breastfeeding women
* Mentally retarded patients
* Patients with immediate loading
* Patients with lesions in the alveolar bone
* Patients who smoke more than 10 cigarettes per day
* Patients who use drugs that suppress the immune system or impair recovery
* Patients using drugs that disrupt bone metabolism
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 marginal bone loss.
Timeframe: 1 year following prosthetic restoration.