Condition category
Oral Health
Date applied
08/05/2008
Date assigned
11/07/2008
Last edited
11/07/2008
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

Mr Tim De Rouck

ORCID ID

Contact details

Laarbeeklaan 1O3
School of Dental Medicine (Gebouw K)
Brussels
1090
Belgium
+32 (0)2 4774960
tim.de.rouck@vub.ac.be

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

The influence of immediate versus delayed restoration of immediate single-tooth implants in the aesthetic region is evaluated. The study documents the treatment outcome of both strategies as well as the hard and soft tissue response. All parameters are carefully recorded to identify the treatment strategy with the best aesthetic results.

Ethics approval

Ethics approval received from the Commissie Medische Ethiek (O.G.016) on the 18th October 2007 (ref: B.U.N. B14320072578).

Study design

Single-centre, randomised single-blind controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Dental implants

Intervention

Two separate treatment groups were randomly created:

Immediate restoration group:
The total treatment is be done in one surgical appointment. After extraction of the failing tooth, the implant is immediately inserted into the extraction cavity. Within 3 hours the implant is loaded with a provisional restoration. At the 6 month recall visit the final restoration (crown) is connected.

Delayed restoration group:
This treatment involves two surgical interventions. First the tooth is extracted and an implant is immediately inserted into the extraction cavity. The surgical site is closed and a 3-month healing period started. Following this healing period implants were uncovered at second-stage surgery and a provisional restoration was connected to the implant. Again at the 6-month recall visit the final restoration (crown) is connected.

For both groups the moment of provisional crown connection is selected as baseline. Restorations were followed-up for at least one year following provisional crown connection.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Mucosa levels were recorded by means of an acrylic stent provided with three direction grooves: mesial, midfacial and distal. All measurements were assessed with a periodontal probe.
1. Papilla levels: a papilla level (mesial papilla level - distal papilla level) is defined as the distance between the top of the corresponding groove and the top of the papilla
2. Midfacial mucosa level: the midfacial level is defined as the distance between the top of the groove and the first contact with the peri-implant mucosa

Secondary outcome measures

At each re-assessment, namely 3, 6 and 12 months after baseline (i.e. provisional crown connection), mesial and distal marginal bone changes over time were calculated using standardised peri-apical radiographs.

Overall trial start date

01/05/2005

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Patients were selected and consecutively treated in the Dental Clinic of the Free University in Brussels (VUB):
1. 18 years or older, either sex (the mean age was 53 with a range of 24 to 76 years)
2. Good oral hygiene
3. Existence of one failing tooth in the anterior maxilla (15 - 25) with both neighbouring teeth present
4. Healthy soft tissues surrounding the facial aspect of the hopeless tooth in perfect harmony with the adjacent teeth
5. Normal to thick-flat gingival biotype
6. Adequate bone height apical to the alveolus of the failing tooth (greater than or equal to 5 mm) to ensure primary implant stability of at least 35 Ncm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Two groups of 24 participants

Participant exclusion criteria

1. Systemic diseases
2. Smoking (greater than or equal to 10 cigarettes a day)
3. Bruxism, lack of posterior occlusion
4. Non-treated periodontal diseases
5. Presence of active infection (pus, fistula) around the hopeless tooth
6. Loss of the labial crest after extraction of the failing tooth

Recruitment start date

01/05/2005

Recruitment end date

01/05/2010

Locations

Countries of recruitment

Belgium

Trial participating centre

Laarbeeklaan 1O3
Brussels
1090
Belgium

Sponsor information

Organisation

Free University of Brussels (VUB) (Belgium) - School of Dental Medicine

Sponsor details

Laarbeeklaan 103
Brussels
1090
Belgium
+32 (0)2 4774960
tim.de.rouck@vub.ac.be

Sponsor type

University/education

Website

http://www.vub.ac.be

Funders

Funder type

University/education

Funder name

Free University of Brussels (VUB) (Belgium) - School of Dental Medicine

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