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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.


- candidate number1686
- NTR NumberNTR422
- ISRCTNISRCTN37243042
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsN/A 
- Public TitleSingle tooth replacement with dental implants in the aesthetic zone A randomized clinical trial of different implant designs and different times of restoration.
- Scientific TitleSingle tooth replacement with dental implants in the aesthetic zone A randomized clinical trial of different implant designs and different times of restoration.
- ACRONYMN/A
- hypothesisThe purpose of this study is to evaluate and compare the aesthetic definitive outcome of 1. Three different implant designs; and 2. Two different times of restoration, namely immediate and conventional restoration. The null hypothesis is that there are no differences in the definitive aesthetic outcome of different implant designs or times of restoration.
- Healt Condition(s) or Problem(s) studiedDental implant
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-sep-2004
- planned closingdate1-sep-2008
- Target number of participants120
- InterventionsPatients 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 period of three months a temporary restoration is made; 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.
- Primary outcomeEsthetic Index according to Meijer et al. 2005.
- Secondary outcome1. Implant survival; 2. Marginal bone resorption; 3. Papil-index; 4. Recession; 5. Patient satisfaction.
- Timepoints
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDrs. L. Hartog, den
- CONTACT for SCIENTIFIC QUERIESDrs. L. Hartog, den
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Nobel Biocare
- PublicationsN/A
- Brief summaryThere are different dental implant systems available specially designed for the replacement of a missing tooth in the aesthetic zone. They differ in surface characteristics and design. There are only a few studies that address the aesthetics of single-tooth replacements and even no prospective clinical trials have been published comparing the aesthetic outcome of different types of implant designs. For instance, the influence of the shape and surface of the collar of the implant on the aesthetic result has not yet been researched. Furthermore, no studies have focused on the aesthetic result of immediately restored dental implants in the anterior zone in comparison with conventionally restored implants. The purpose of this study is to evaluate and compare the aesthetic definitive outcome of (1) three different implant designs, and (2) two different times of restoration, namely immediate and conventional restoration. The null hypothesis is that there are no differences in the definitive aesthetic outcome of different implant designs or times of restoration.
- Main changes (audit trail)
- RECORD15-sep-2005 - 14-jan-2010


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