Implantology, tooth replacement Implants, Crowns, Screws
Conditions
Interventions
The study intervention (IIP) involves a surgical procedure that includes the extraction of the natural tooth and the simultaneous replacement with an implant (immediate implant placement, IIP). The pr
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • At least 18 years old• Presence of a failing tooth in the anterior region • Periodontally healthy patients (periodontal probing depths ? 4 mm) (full mouth)• Good oral hygiene (full mouth plaque index <25%); • Adequate control of inflammation (full mouth bleeding on probing <25%);
Exclusion criteria
Exclusion criteria: • Pregnant or lactating women• Smokers (>10 cigarettes/day)• Currently taking drugs that influence bone metabolism• Systemic or local conditions presenting a contraindication to implant treatment• Use of bisphosphonates in the last 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study will be the midfacial mucosal recession between pre-extraction and crown delivery (2 weeks after crown delivery). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints:Overall patient satisfaction 2 weeks after crown placement (BL2) measured with a numerical rating scale (NRS) from 0 (completely dissatisfied) to 10 (completely satisfied).OHIP-14 (Oral Health Impact Profile, Questionnaire) during screening, 2 weeks after crown placement (BL2), and in the long-term follow-up phase (after 1 year, 3 years, and 5 years).Pain assessment after each procedure (extraction and implantation).Overall patient satisfaction after 1 year, 3 years, and 5 years follow-up.Overall dentist satisfaction 2 weeks after crown placement and after 1 year, 3 years, and 5 years follow-up.Horizontal thickness (in mm) of the regenerated bone on the buccal side of the implant after 1 year, 3 years, and 5 years follow-up.Clinical parameters (Pocket Depth, Plaque Control Record, Modified sulcus Bleeding Index, Bleeding On Probing, Keratinized Mucosa, crown height) of the investigated site and adjacent teeth during screening and at different later time points (BL2, 1 year, 3 years, and 5 years follow-up).Contour changes (in mm) on the buccal side of the extraction site from before extraction (BL1) to BL2 (2 weeks after crown placement) and to 1 year, 3 years, and 5 years follow-up.PES/WES score (Pink Esthetic Score; White Esthetic Score) before and after crown placement (2 weeks after placement, after 1 year, 3 years, and 5 years follow-up).Ease of treatment by the dentist (from extraction to implantation) measured with a numerical rating scale (NRS). | — |
Countries
Netherlands, Switzerland
Contacts
Public ContactM Chin
Erasmus MC, Universitair Medisch Centrum Rotterdam
Outcome results
None listed