Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla

Study Overview
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Brief Summary
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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

Detailed Description
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The primary objective of this study is to determine the level at which the bone can be maintained in relation to the implant shoulder for the P.004 two-stage implant when placed in a submerged or a trans-mucosal procedure in single tooth gaps in the anterior region. The primary parameter will be measured by radiography 26 weeks after loading of the implant.

Official Title
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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

Conditions
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Jaw, Edentulous, Partially

Intervention / Treatment
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* Device: Straumann Bone Level Implant


Participation Criteria
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Eligibility Criteria
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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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Submerged healing<br>The Straumann Bone Level Implant(s) will be placed using a submerged healing treatment | Device: Straumann Bone Level Implant<br>* Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm<br>|
| Active Comparator: Trans-mucosal healing<br>The Straumann Bone Level Implant(s) will be placed using a trans-mucosal healing treatment | Device: Straumann Bone Level Implant<br>* Straumann Bone Level Implant, SLActive surface, diameter 4.1, length 8, 10, 12, and 14 mm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant Survival Rate | The percentage of implants that remain in place in the jaw. | 6 months | 
| Implant Survival Rate | The percentage of implants that remain in place in the jaw. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implant