Patients with a failing incisor (central or lateral), cuspid or first bicuspid in the maxilla.
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • The patient is 18 years or older; • The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth; • Sufficient healthy and vital bone after alveolar ridge preservation to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability > 45 Ncm; • The implant site must be free from infection; • Adequate oral hygiene (modified plaque index and modified sulcus bleeding index = 1); • Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration; • The temporary restoration can be designed free from occlusal contact; • The patient is capable of understanding and giving informed consent.
Exclusion criteria
Exclusion criteria: • Medical and general contraindications for the surgical procedures; • Presence of an active and uncontrolled periodontal disease; • Bruxism; • Smoking • A history of local radiotherapy to the head and neck region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in approximal marginal bone level measured on standardized digital intra-oral radiographs during the evaluation period. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Treatment time (total time of diagnostic, surgical, prosthetic and dental laboratory) • Implant survival and restoration survival • Change in mid-buccal mucosal level (MBML), assessed from standardized intra-oral photographs taken before tooth extraction (Tpre), one (T1) and 12 months (T12) after final implant crown placement • Changes in inter-proximal mucosal levels (IML), assessed from standardized intra-oral photographs taken before tooth extraction (Tpre), one (T1) and 12 months (T12) after final implant crown placement • Peri-implant mucosa and implant crown aesthetics assessed from photographs taken at T12 using the Pink Esthetic Score-White Esthetic Score (PES/WES). • Change in buccal bone thickness measured on CBCT’s (Meijer et al. 2018) between Tpre, T1 and T12 • Probing pocket depth using a periodontal probe at the mesio-buccal, mid-buccal, and disto-buccal and mid-palatal aspect at T1 and T12 • Amount of plaque (modified plaque index, Mombelli et al. 1987) at T1 and T12 • Bleeding after probing (modified sulcus bleeding index, Mombelli et al. 1987) at T1 and T12 • Gingival condition (gingival-index, Löe 1967) at T1 and T12 • Width of the keratinized mucosa: no keratinized mucosa, <1mm of keratinized mucosa, 1-2mm of keratinized mucosa, =2mm of keratinized mucosa • Volume of the interproximal papilla, using the papilla index (Jemt 1997) at T1 and T12 • Patient satisfaction | — |
Contacts
University Medical Center Groningen