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Single tooth replacement with dental implants in the aesthetic zone A randomized clinical trial of different implant designs and different times of restoration.

Single tooth replacement with dental implants in the aesthetic zone A randomized clinical trial of different implant designs and different times of restoration.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25803
Enrollment
120
Registered
2005-09-15
Start date
2004-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental implant, single-tooth

Interventions

Patients are randomly assigned to the following study groups: Group I: a dental implant of the ‘NobelReplace Tapered’ system is inserted in the anterior zone of the maxilla. After an osseointegration
Group IIA: a dental implant of the ‘NobelReplace Groovy’ system is inserted in the anterior zone of the maxilla. Within 24 hours a temporary restoration is placed
Group IIB: a dental implant of the ‘NobelReplace Groovy' system is inserted in the anterior zone of the maxilla and a temporary restoration is made after three months
Group III: a dental implant of the ‘NobelPerfect’ system is inserted in the anterior zone of the maxilla and a temporary restoration is made after three months.

Sponsors

- University Medical Center Groningen, University of Groningen - Nobel Biocare
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient is 18 years or older; 2. The missing or lost tooth is an incisor (central or lateral), a canine or a first bicuspid in the maxilla. The adjacent teeth are natural teeth; 3. Sufficient healthy and vital bone to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone. After three months of healing, the dental implant will then be inserted; 4. The implant site must be free from infection; 5. Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ¡Ü 1); 6. Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration; 7. If necessary, the temporary restoration can be designed free from occlusal contact; 8. The patient is capable of understanding and giving informed consent.

Exclusion criteria

Exclusion criteria: 1. Medical and general contraindications for the surgical procedures; 2. Presence of an active and uncontrolled periodontal disease; 3. Presence of pathologic microflora; 4. Bruxism; 5. Site of implant placement is an extraction wound younger than three months; 6. Smoking (patients who stop smoking six weeks before the operation can be included); 7. A history of local radiotherapy to the head and neck region.

Design outcomes

Primary

MeasureTime frame
Esthetic Index according to Meijer et al. 2005.

Secondary

MeasureTime frame
1. Implant survival; 2. Marginal bone resorption; 3. Papil-index; 4. Recession; 5. Patient satisfaction.

Contacts

Public ContactL. Hartog, den

University Medical Center Groningen (UMCG), Hanzeplein 1

L.den.hartog@kchir.umcg.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)