Contact information
Type
Scientific
Primary contact
Dr L. Hartog, den
ORCID ID
Contact details
University Medical Center Groningen
Hanzeplein 1
Groningen
9713 GZ
Netherlands
L.den.hartog@kchir.umcg.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR422
Study information
Scientific title
Acronym
Study hypothesis
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
Received from local medical ethics committee
Study design
Randomised open label active controlled parallel group
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2004
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/09/2004
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9713 GZ
Netherlands
Funders
Funder type
Industry
Funder name
Nobel Biocare (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary