Immediate Implants: to Graft or Not to Graft, That is the Question. (NCT05927181) | Clinical Trial Compass
CompletedNot Applicable
Immediate Implants: to Graft or Not to Graft, That is the Question.
Spain31 participantsStarted 2009-04
Plain-language summary
The aim was to compare two protocols for immediate implants with fixed provisional restoration, no grafting (trimodal approach=TA) versus grafting both osseous gap and peri-implant mucosa (trimodal approach with modification of the osseous and mucosal compartments =TAOM) by measuring the soft tissue changes overtime. The periodontal phenotype was registered, to investigate a relationship between its thickness and the clinical outcomes.
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:
* Need for tooth extraction in the anterior maxilla (13-23) due to cavities, internal resorption, fractures, restorative problems, endodontic complications and prosthetic reasons.
* The failing tooth has adjacent and opposing natural teeth
* Adequate oral hygiene (Bleeding on probing \<20%; Plaque index \<20%);
* Absence of active and uncontrolled periodontal disease
* Sufficient mesial-distal and interocclusal space for implant placement and definitive restoration
* Sufficient interocclusal space to design a non-occluding provisional restoration
Exclusion Criteria:
* Systemic metabolic or osseous disease that could compromise peri-implant tissue healing.
* Acute infection in the treatment area
* Absence of one or both adjacent teeth
* Non-integrity of the buccal bone wall (dehiscence or fenestration) observed during surgery, or when tooth extraction has altered the integrity of the osseous and gingival architecture
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
Distance from measuring points on the reference stent to gingival zenith of the implant restoration in tenths of a milimetre by means of a precision digital calliper.