Active — Not RecruitingNot Applicable

Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts

United States36 participantsStarted 2022-04-01

Plain-language summary

The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site. Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.

Who can participate

Age range

18 Years – 80 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: * Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019) * Well-controlled systemic disease. * Able to understand and sign a written informed consent form and willing to fulfill all study requirements. Exclusion Criteria: * Uncontrolled systemic disease. * Currently smoking \>10 cigarettes per day. * History of head and/or neck radiotherapy in the past five years. * Current use of bisphosphonates or history of IV bisphosphonate therapy. * Pregnant, expecting to become pregnant, or lactating women. * Presence of active periodontal disease.

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

Implant Stability as Measured with ISQ values of implant

Timeframe: 6 months

Implant Failure Rate

Timeframe: 6 months

Probing pocket depth

Timeframe: 6 months

Interproximal crestal bone level

Timeframe: 6 months

Trial details

NCT IDNCT05219305

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-10

View on ClinicalTrials.gov More Edentulous Alveolar Ridge trials

Plain-language summary

Who can participate

Age range

18 Years – 80 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.