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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00906425




Registration number
NCT00906425
Ethics application status
Date submitted
19/05/2009
Date registered
19/05/2009
Date last updated
2/03/2016

Titles & IDs
Public title
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
Scientific title
Randomized, Controlled Clinical Study Comparing Submerged vs. Trans-mucosal Placement of P.004 Implants in the Anterior Maxilla and Mandible by Evaluation of the Change in Bone Level Between 1st Stage Surgery and 6 Months Post Surgery
Secondary ID [1] 0 0
CR 05/05
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Jaw, Edentulous, Partially 0 0
Jaw, Edentulous, Partially 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Straumann Bone Level Implant
Treatment: Devices - Straumann Bone Level Implant

Active Comparator: Submerged healing - The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment

Active Comparator: Trans-mucosal healing - The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment

Active Comparator: Submerged healing - The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment

Active Comparator: Trans-mucosal healing - The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment


Treatment: Devices: Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Treatment: Devices: Straumann Bone Level Implant
Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) - The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Timepoint [1] 0 0
Baseline and 6 months
Primary outcome [2] 0 0
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery) - The primary aim is to measure the bone level change between mesial and distal aspects of the implant at 6 months post implantation. The reference point for the bone level measurement is the implant shoulder.
Timepoint [2] 0 0
Baseline and 6 months
Secondary outcome [1] 0 0
Implant Survival Rate - The percentage of implants that remain in place in the jaw.
Timepoint [1] 0 0
6 months
Secondary outcome [2] 0 0
Implant Survival Rate - The percentage of implants that remain in place in the jaw.
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Implant Survival Rate - The percentage of implants that remain in place in the jaw.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Implant Survival Rate - The percentage of implants that remain in place in the jaw.
Timepoint [4] 0 0
12 months

Eligibility
Key inclusion criteria
- Males and females >18 years of age.

- Implant placement planned in the anterior maxilla or mandible (FDI tooth numbers 21 -
25, 11 - 15, 31-35, 41-45).

- Tooth site must have a natural tooth both mesially and distally in the adjacent tooth
positions

- Opposing dentition of natural teeth, or tooth or implant-supported fixed restorations.

- Adequate bone quality and quantity at the implant site to permit the insertion of a
Straumann P.004 SLActive implant of 8, 10, 12, or 14 mm length.

- Presence of a sufficient band of keratinized mucosa (min. 2 mm) to allow surgical
manipulation and suturing according to the protocol

- Signed informed consent document before being treated in the study
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled
diabetes)

- Any contraindications for oral surgical procedures

- Current untreated periodontitis or gingivitis

- Probing pocket depth of more than 4 mm at one of the adjacent teeth

- Mucosal diseases (e.g. erosive lichen planus)

- History of local irradiation therapy

- Bone augmentation procedures if the procedure require healing time of more than 12
weeks after implant placement

- Implants in adjacent position to planned implant

- Severe bruxing or clenching habits

- Heavy smokers: Patients who smoke more than 20 cigarettes per day

- Conditions or circumstances, in the opinion of the investigator, which would prevent
completion of study participation.

- Patients with inadequate oral hygiene or unmotivated for adequate home care

Secondary Exclusion Criteria at Implant Surgery:

- Lack of primary stability of the implant

- Inappropriate implant position to insert implants according to the prosthetic
requirements.

- Patients with augmentation procedures requiring more than 12 weeks healing time.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dr. Stephen T. Chen - Melbourne
Recruitment postcode(s) [1] 0 0
3123 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
Germany
State/province [2] 0 0
Schleswig Holstein
Country [3] 0 0
Germany
State/province [3] 0 0
München
Country [4] 0 0
Germany
State/province [4] 0 0
Stuttgart
Country [5] 0 0
Germany
State/province [5] 0 0
Witten/ Herdecke
Country [6] 0 0
Italy
State/province [6] 0 0
Rom
Country [7] 0 0
Spain
State/province [7] 0 0
Madrid
Country [8] 0 0
Sweden
State/province [8] 0 0
Mölndal
Country [9] 0 0
Switzerland
State/province [9] 0 0
Zurich

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Institut Straumann AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is To demonstrate that there is no difference in change in bone
level around P.004 implants between 1st stage surgery and 6 months post surgery when
transmucosal implant placement is compared to submerged implant placement
Trial website
https://clinicaltrials.gov/show/NCT00906425
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christoph Hammerle
Address 0 0
University of Zurich
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications