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Completed
NCT07731854
Custom Provisionalisation
Conditions: Tooth Loss and Rehabillitation
Sex: All
Ages: 25 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 36
Sponsor: Universitaire Ziekenhuizen KU Leuven
Location: UZ Gent Ghent Oost-Vlaanderen
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.
Eligibility Criteria
Inclusion Criteria:
1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Males or females ASA I or II, between 25 to 80 years of age
3. One tooth in the high esthetic region planned for extraction.
4. Patient in good general health as documented by self-assessment.
5. Patients must be committed to the study and must be willing to sign the informed consent.
Exclusion Criteria:
1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device
4. Any systemic medical condition that could interfere with the surgical procedure or planned treatment.
5. Immunosuppression, Diabetes, Anticoagulation or Antiaggregatory medication.
6. Current pregnancy or breast feeding/ lactating at the time of recruitment.
7. Radiotherapy or Chemotherapy in head and neck area.
8. Intravenous and oral bisphosphonate therapy.
9. Smokers
10. Unwillingness to return for the follow-up examination.
11. Conditions or circumstances, in the opinion of the investigator, which could represent a general contra-indication for surgical procedure or would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unrealistic expectations.
12. Presence of osseous pathologies, that may interfere with normal wound healing.
13. Presence of oral lesions (such as ulceration, malignancy).
14. Local inflammation, including untreated periodontitis.
15. Patients with inadequate oral hygiene or unmotivated for adequate home care
Source: ClinicalTrials.gov (NCT07731854). StuddyBuddy aggregates publicly available trial information.
