Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without P… (NCT05106855) | Clinical Trial Compass
CompletedNot Applicable
Comparative Study of Immediate Single Unit Implants in Early Loading Protocols, With or Without Photobiomodulation.
Spain60 participantsStarted 2022-03-03
Plain-language summary
Post-extraction implants are an alternative to traditional implant placement on completely healed bone, in order to reduce the number of surgical interventions, shorten treatment time, maintain bone architecture and thus provide better aesthetics. This study focuses on evaluating the results obtained by opting for different immediate placement of single dental implants protocols in a fresh alveolus, and its general objective is to compare implant stability and marginal bone loss (MBL) in implants installed post-extraction. For this, the investigators will placement Grand Morse Acqua or NeoPoros implants (Helix GM - Neodent, Curitiba, Brazil), in early loading protocols, with or without low level laser photobiomodulation (LLLT), in patients attending the Master of Oral Medicine, Oral Surgery and Implantology of the University of Santiago de Compostela for oral rehabilitation using osseointegrated single dental implants in the maxillary and/or mandibular region.
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 satisfying all inclusion criteria and none of the exclusion criteria will be informed verbally and in writing about the study and signed the informed consent form.
* The implant area is free of infection
* Patients without systemic pathology or medical and general contraindications that are absolute contraindications for surgical procedures;
* Adults who agree to take part in the study and signed the informed consent form.
* Smokers of less than 5 cigarettes/day.
* Not to be completely edentulous.
* Need for extraction of at least one tooth.
* Post-extraction bone area (fresh alveolus).
* Patients with sufficient bone height to obtain primary stability for implant installation (2 mm longer than the largest root).
* Edentulous areas with sufficient mesial-distal, buccolingual and interocclusal space for the placement of an anatomical restoration with a prosthetic space of at least 5 mm.
Exclusion Criteria:
* Immunosuppressed.
* Smokers of more than 5 cigarettes/day.
* Bleeding rate greater than 30 %.
* Presence of active or uncontrolled periodontal disease;
* Patients with less than 2 mm of keratinised gingiva.
* Implants with primary stability with ISQ \< 50
* When this is not possible, assume a security margin to the inferior dental nerve of at least 1 mm.
* Previus history of local radiotherapy in 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.