CompletedNot Applicable

Custom Provisionalisation

Belgium36 participantsStarted 2022-05-29

Plain-language summary

Fully digital immediate implant treatment by means of fully guided implant placement and custom designed provisionalisation with a individual designed abutment and temporary PMMA crown leads to better esthetic outcomes than free handed with regular provisionalisation on a temporary cylinder.

Who can participate

Age range

25 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

. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
. Males or females ASA I or II, between 25 to 80 years of age
. One tooth in the high esthetic region planned for extraction.
. Patient in good general health as documented by self-assessment.
. Patients must be committed to the study and must be willing to sign the informed consent.

Exclusion criteria

. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
. Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
. Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.

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

mid-facial recession (mm)

Timeframe: 6 months and 1 year after surgery

PES (pink esthetic score)

Timeframe: 6 months and 1 year after surgery

WES (white esthetic score

Timeframe: 6 months and 1 year after surgery

Trial details

NCT IDNCT07731854

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Tooth Loss and Rehabillitation trials

Who can participate

Age range

25 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

. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
. Males or females ASA I or II, between 25 to 80 years of age
. One tooth in the high esthetic region planned for extraction.
. Patient in good general health as documented by self-assessment.
. Patients must be committed to the study and must be willing to sign the informed consent.

Exclusion criteria

. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
. Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
. Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.