Condition category
Oral Health
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Not defined

Website

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

Publication citations

Additional files

Editorial Notes