Immediate versus delayed restoration of immediate single-tooth implants in the anterior maxilla

ISRCTN	ISRCTN42997954
DOI	https://doi.org/10.1186/ISRCTN42997954
Protocol serial number	N/A
Sponsor	Free University of Brussels (VUB) (Belgium) - School of Dental Medicine
Funder	Free University of Brussels (VUB) (Belgium) - School of Dental Medicine

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

Laarbeeklaan 1O3
School of Dental Medicine (Gebouw K)
Brussels
1090
Belgium

Phone	+32 (0)2 4774960
Email	tim.de.rouck@vub.ac.be

Study information

Primary study design	Interventional
Study design	Single-centre, randomised single-blind controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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
Key secondary outcome measure(s)	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.
Completion date	01/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	48
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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes