Single tooth replacement with dental implants in the aesthetic zone. A randomized clinical trial of different implant designs and different times of restoration.
| ISRCTN | ISRCTN37243042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37243042 |
| Secondary identifying numbers | NTR422 |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 19/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr L. Hartog, den
Scientific
Scientific
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
| L.den.hartog@kchir.umcg.nl |
Study information
| Study design | Randomised open label active controlled parallel group |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The purpose of this study is to evaluate and compare the aesthetic definitive outcome of: 1. Three different implant designs 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. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Dental implant, single-tooth |
| Intervention | 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 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 |
| Intervention type | Other |
| Primary outcome measure | Aesthetic Index according to Meijer et al. 2005 |
| Secondary outcome measures | 1. Implant survival 2. Marginal bone resorption 3. Papil-index 4. Recession 5. Patient satisfaction |
| Overall study start date | 01/09/2004 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 <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 |
| Key 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 |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Center Groningen
Groningen
9713 GZ
Netherlands
9713 GZ
Netherlands
Sponsor information
University Medical Centre Groningen (UMCG) (Netherlands)
Not defined
Not defined
Hanzeplein 1
Groningen
9713 GZ
Netherlands
"ROR" |
https://ror.org/03cv38k47 |
|---|
Funders
Funder type
Industry
Nobel Biocare (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
