Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Ret… (NCT06083506) | Clinical Trial Compass
CompletedNot Applicable
Immediate Loading of 4 Guided Implants Supporting a Maxillary Overdenture Using a Novaloc TiN Retention System
United States17 participantsStarted 2019-01-03
Plain-language summary
Complete dentures represent the traditional dental treatment for patients without teeth. However, retention and stability of this type of denture are often lacking, so dental implants are indicated in order to improve the stability of the denture, along with the satisfaction of the patient. Usually, the dental implants are inserted and then a period of 3-6 months is waited before any denture is connected to them. Recent studies have demonstrated that connecting the lower denture to the implants immediately after the implant placement, leads to an improvement in the result, with a social and psychological benefit for the patient. Therefore, the aim of this research project is to evaluate the application of the immediate connections of the implants for the upper dentures. 15-40 patients wearing an upper denture will receive 4 dental implants and the denture will be immediately connected. To simplify the surgical procedure, the implants will be placed without exposing the bone. This surgical technique is called guided surgery. Secondary objective of this research project will be the evaluation of the precision of the implant positioning, using this specific technique. The patients will be followed up for 12 months, for the implant and denture evaluation, as well as the evaluation of patient satisfaction and impact on quality of life through questionnaires.
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.
Inclusion Criteria:
* Fully edentulous maxilla
* The implant site has to be healed for at least 4 months after extraction
* Wearing complete dentures deemed adequate
* Orthopantomogram available (OPT)
* Adequate amount of bone at least at the 2nd premolar position to house a 3.75 x 10 mm implant
* No bone grafting required
* Implant IT ≥ 20 N/cm
Exclusion Criteria:
* Conditions requiring chronic routine prophylactic use of antibiotics
* Conditions requiring prolonged use of steroids
* History of leukocyte dysfunction and deficiencies
* Bleeding disorders
* History of neoplastic disease requiring use of radiation or chemotherapy
* Metabolic bone disorders
* Uncontrolled endocrine disorder
* Use of any investigational drug or device within the 30-day period prior to implant surgery
* Smoking more than 10 cigarettes a day
* Alcoholism or drug abuse
* Patient infected with HIV
* Condition or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, unreliability.
Local exclusion criteria:
* Local inflammation including untreated periodontitis
* Mucosal disease such as erosive lichen planus
* History of local irradiation therapy
* Osseous lesion
* Severe bruxism and clenching habits
* Active infection with suppuration or fistula track
* Persistent intraoral infection
* Lack of primary stability \<20Ncm. In this instance, the patient must be withdrawn …
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.