Skip to content

Implant-supported single tooth replacements in the aesthetic zone: a randomized clinical trial

Implant-supported single tooth replacements in the aesthetic zone: a randomized clinical trial - Implant-supported single tooth replacements in the aesthetic zone

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41534
Enrollment
90
Registered
2010-06-08
Start date
2010-07-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Aandoeningen aan het gebit Missing tooth

Interventions

For this study, three different study groups are introduced. Patients allocated to the first study group were treated with a Replace Select Tapered implant (Nobel Biocare AB, Gothenburg, Sweden) (sm

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -The patient is 18 years or older; -The missing or lost tooth is an incisor (central or lateral), a canine or a first premolar in the maxilla. The adjacent teeth are natural teeth; -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; -The implant site must be free from infection; -Adequate oral hygiene (modified plaque index and modified sulcus bleeding index

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Changes in marginal peri-implant bone loss

Secondary

MeasureTime frame
Clinical performance, namely: -Implant survival. -Implant Crown Aesthetic Index. One month and one and five year after placement of the final restoration, the Implant Crown Aesthetic Index is assessed as described by Meijer et al., 2005. The aesthetic index is assessed on standardized photographic images, taken according to Meijndert et al., 2004. -Modified Plaque-index and Modified Bleeding-Index (Mombelli et al., 1987), Gingiva index (Loë and Silness, 1963). These parameters are evaluated pre-operative, one month and one and five year after placement of the definitive restoration. The adjacent teeth are counted as well in the assessments. -Papil-index (Jemt et al., 1997). This index is evaluated pre-operative, one month and one and five year after definitive restoration. The Papil-index is assessed on the standardized photographic images. -Probing depth. Probing of the implant and the adjacent teeth is performed at three sites, buccodistal, buccomedial, buccomesial. The probing depth is measured pre-operative, one month and one and five year after placement of the definitive restoration. -Recession. The degree of recession is measured on the standardized photographic images. Therefore the distance is measured between the most cervical and mediobuccal point of the marginal gingiva perpendicular to the incisal edge of the definitive crowns one week and one year after placement. The adjacent teeth are counted as well in the measurements. Also the distance between the most coronal point of the mesial and distal papil perpendicular to the incisal edge of the natural adjacent tooth is determined. This is done on the standardized photographic images taken pre-operative, one month and one and five year after definitive restoration. -Width of keratinized epithelium. The width in millimetres of keratinized epithelium is measured pre-operative, one month and one and five year after the definitive restoration has been placed. This is done by using

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)