Peri-implant Tissues Changes for Different Abutment Shapes and Heights (NCT07509281) | Clinical Trial Compass
RecruitingNot Applicable
Peri-implant Tissues Changes for Different Abutment Shapes and Heights
Spain180 participantsStarted 2026-06-01
Plain-language summary
The goal of this randomized clinical trial is to investigate the influence of supracrestal soft tissue on abutments of different heights (2-mm vs. 3-mm) and shapes (cylindrical abutment vs. concave abutment) on changes in the marginal bone level (bone loss and bone remodeling) in healthy, partially edentulous volunteer patients undergoing implant-supported rehabilitation.
The main questions it aims to answer are:
* Is there any difference in marginal bone loss for different abutment shapes and heights?
* Do the shape and height of the abutment affect implant success?
All participants will receive bone-level dental implants placed approximately 2-mm below the bone crest, each receiving a different type of abutment and researchers will see whether the shape and height of the abutment influence the success of the implant, periodontal probing depth (PPD), and bleeding on probing (BoP) comparing four groups of patients:
1. 2-mm high abutments with cylindrical shape.
2. 2-mm high abutments with concave shape.
3. 3-mm high abutments with cylindrical shape.
4. 3-mm high abutments with concave shape.
Clinical and radiographic assessments will be performed at abutment placement, at definitive prosthesis placement, and at 1, 3, 6, and 12 months after loading to measure marginal bone loss and peri-implant parameters.
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:
* Adults aged 18 years or older.
* Posterior edentulism (premolars/molars).
* Good general and oral health, with controlled plaque and bleeding indices.
* Sufficient bone height and width for implant placement without the need for bone regeneration procedures. Patients who require indirect sinus lift procedure simultaneously with implant placement may be included in the study.
* Presence of at least 2 mm of keratinized mucosa around the dental implant.
* Stable occlusion and healthy periodontium.
* Insertion torque ≥ 35 Ncm at the time of implant placement.
* Willingness to comply with study protocol and attend scheduled follow-up visits.
Exclusion Criteria:
* Presence of medical conditions that contraindicate implant surgery, such as heavy smoking (\>10 cigarettes per day), severe bruxism, pregnancy or breastfeeding, bisphosphonate therapy, and patients undergoing chemotherapy or radiotherapy in the head and/or neck area.
* Active periodontal disease or peri-implant infection.
* Uncooperative patients or patients unable to complete follow- up.
* Implant failures.
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
Changes in peri-implant marginal bone level (mm)
Timeframe: From abutment placement (baseline time [TB]), 3 months post-op (prosthetic loading) (T0), and at months 1 (T1), 3 (T3), 6 (T6), and 12 (T12) after definitive prosthesis placement.