Immediate versus delayed restoration of immediate single-tooth implants in the anterior maxilla
| ISRCTN | ISRCTN42997954 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42997954 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/05/2008
- Registration date
- 11/07/2008
- Last edited
- 11/07/2008
- 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
Mr Tim De Rouck
Scientific
Scientific
Laarbeeklaan 1O3
School of Dental Medicine (Gebouw K)
Brussels
1090
Belgium
| Phone | +32 (0)2 4774960 |
|---|---|
| tim.de.rouck@vub.ac.be |
Study information
| Study design | Single-centre, randomised single-blind controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study objectives | 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(s) | Ethics approval received from the Commissie Medische Ethiek (O.G.016) on the 18th October 2007 (ref: B.U.N. B14320072578). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/05/2005 |
| Completion date | 01/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Two groups of 24 participants |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2005 |
| Date of final enrolment | 01/05/2010 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Laarbeeklaan 1O3
Brussels
1090
Belgium
1090
Belgium
Sponsor information
Free University of Brussels (VUB) (Belgium) - School of Dental Medicine
University/education
University/education
Laarbeeklaan 103
Brussels
1090
Belgium
| Phone | +32 (0)2 4774960 |
|---|---|
| tim.de.rouck@vub.ac.be | |
| Website | http://www.vub.ac.be |
"ROR" |
https://ror.org/006e5kg04 |
Funders
Funder type
University/education
Free University of Brussels (VUB) (Belgium) - School of Dental Medicine
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 |
