K08.1
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written consent to voluntary participation in the study was obtained prior to study entry. 2. Single-tooth restorations in the partially edentulous mandible and/or maxilla: Single-tooth gaps with sufficient bone to accommodate an implant with a diameter of 3.8 mm, 4.3 mm, or 5.0 mm. 3. Tooth extraction at least 12 weeks prior to implantation. 4. Opposing jaw consisting of natural teeth or fixed restoration. 5. Systemically healthy patients with no contraindications to oral surgery. 6. Informed patients willing to participate in follow-up examinations.
Exclusion criteria
Exclusion criteria: 1. Smokers (>10 cigarettes daily, cigar equivalents, or chewing tobacco). 2. Systemic diseases that could compromise surgical implantation (e.g., uncontrolled diabetes). 3. Uncontrolled parafunctional disorders (e.g., bruxism, teeth grinding, or clenching). 4. Medical conditions that limit the ability to maintain adequate oral hygiene. 5. Conditions or circumstances that, in the opinion of the investigator, could compromise study completion or outcome analysis (e.g., noncompliance or unreliability). 6. Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival and success rate in % of implants after 6, 12, 36, 48, 60 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Pink Esthetic Score, White Esthetic Score, patient-reported outcomes (PROMs) Peri-implant tissue health (bleeding on probing; probing depth; mucosal recession; keratinized mucosa; plaque index; and suppuration) 6, 12, 36, 48, 60 months. | — |
Countries
Germany
Contacts
Zentrum der Zahn-, Mund- und Kieferheilkunde (Carolinum) der Johann Wolfgang Goethe-Universität Frankfurt am Main Poliklinik für Zahnärztliche Chirurgie