Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior… (NCT00906425) | Clinical Trial Compass
CompletedNot Applicable
Clinical Study Comparing Submerged Versus Trans-mucosal Healing of P.004 Implants in the Anterior Mandible and Maxilla
United States, Australia, Germany145 participantsStarted 2006-10
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 w…
What they're measuring
1
Mean Change in Bone Level (Distance B) After 6 Months Compared to Baseline (=Surgery)