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ISRCTN
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ISRCTN42997954
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ClinicalTrials.gov identifier
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Public title
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Immediate versus delayed restoration of immediate single-tooth implants in the anterior maxilla
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Ethics approval received from the Commissie Medische Ethiek (O.G.016) on the 18th October 2007 (ref: B.U.N. B14320072578).
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Study design
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Single-centre, randomised single-blind controlled clinical trial
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Countries of recruitment
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Belgium
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Disease/condition/study domain
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Dental implants
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2005
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Anticipated end date
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01/05/2010
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Status of trial
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Ongoing
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Two groups of 24 participants
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Interventions
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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.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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.
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Sources of funding
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Free University of Brussels (VUB) (Belgium) - School of Dental Medicine
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Trial website
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Publications
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Contact name
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Mr
Tim
De Rouck
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Address
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Laarbeeklaan 1O3
School of Dental Medicine (Gebouw K)
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City/town
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Brussels
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Zip/Postcode
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1090
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Country
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Belgium
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Tel
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+32 (0)2 4774960
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Fax
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+32 (0)2 4774922
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Email
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tim.de.rouck@vub.ac.be
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Sponsor
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Free University of Brussels (VUB) (Belgium) - School of Dental Medicine
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Address
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Laarbeeklaan 103
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City/town
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Brussels
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Zip/Postcode
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1090
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Country
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Belgium
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Tel
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+32 (0)2 4774960
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Fax
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+32 (0)2 4774922
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Email
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tim.de.rouck@vub.ac.be
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Sponsor website:
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http://www.vub.ac.be
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Date applied
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08/05/2008
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Last edited
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11/07/2008
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Date ISRCTN assigned
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11/07/2008
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