Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation (NCT05610748) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Implant-supported Rehabilitation With SPAL Technique or Soft Tissue Augmentation
Italy66 participantsStarted 2022-07-01
Plain-language summary
The primary aim of the present study is to compare the Sub-periosteal Peri-implant Augmented Layer (SPAL) technique and soft tissue augmentation (STA), performed simultaneously to implant placement, in terms of (i) implant survival rate and (ii) health/disease condition of the peri-implant tissues at 6 and 12 months following implant loading. The secondary aim of the project will be to compare the SPAL technique and STA in terms of intra- and post-operative morbidity.
The study is designed as a single-blind, parallel-arm, randomized clinical trial. Patients will be recruited and treated at the Operative Unit of Dentistry, Azienda Unità Sanitaria Locale (A.U.S.L.) of Ferrara, Italy, and one University center (Research Centre for the Study of Periodontal and Peri-implant Diseases, University of Ferrara, Italy). Each patient will contribute the study with one sextant ("experimental sextant"). Each eligible patient will be randomly assigned to receive SPAL technique or STA according to a computer-generated randomization list. Surgical procedures will be performed by experienced periodontal and implant surgeons. Two calibrated, blinded examiners will take care of the assessment of clinical and radiographic parameters, Case Report Form (CRF) filling, as well as data extraction from CRFs for the preparation of the study database.
The proportion of patients free from peri-implantitis at 12 months following loading will be the primary outcome variable of the study. The proportion of patients with complete resolution of the bone dehiscence (BD), dimensional variations and 12-months characteristics of BD, and patient-reported outcome measures will be the secondary outcomes. The design will test two hypotheses, with a non-inferiority trial in terms of primary outcome and a superiority trial in terms of secondary outcomes.
Who can participate
Age range
21 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.
Patient-specific inclusion criteria
* age≥21years;
* good physical status (ASA1 and ASA2 according to Physical Status Classification System) (American Society of Anesthesiologists, 2010);
* systemic and local conditions compatible with implant placement and experimental procedures;
* indication to a fixed, implant-supported prosthetic rehabilitation with hard or soft tissue reconstructive procedures as part of the comprehensive oral rehabilitation plan;
* patient willing and fully capable to comply with the study protocol.
Sextant-specific inclusion criteria
To be considered as experimental, a sextant will have to fulfill all the following criteria:
* including at least one healed (i.e., ≥ 6 months elapsed from tooth loss) edentulous site;
* horizontal dimension of the edentulous ridge compatible with the primary stability of an implant of at least 3.5 mm in diameter;
* expected peri-implant buccal BD characterized by a height (measured as the apico-coronal height of the exposed implant surface) ≤ 5 mm or a thin (\< 1 mm) peri-implant buccal bone plate as diagnosed on tridimensional planning for guided implant placement.
Patient will not be eligible for the study if presenting at least one of the following exclusion criteria:
Patient-specific exclusion criteria
* current heavy smoking (≥20 cigarettes/day for ≥6 months prior to and at the time of the surgical procedure);
* untreated periodontal disease prior to implant placement;
* history of radiation therapy in the he…
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.