A clinical research to evaluate the performance of Straumann Tissue Level Implants with SLA surface in Single Tooth Gaps in the pre-molar and molar region

UMIN ID: UMIN000007740

Registered date:13/04/2012

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Single Tooth Gaps in the pre-molar and molar region
• Date of first enrollment: 2012/04/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Standerdized X-ray

Outcome(s)

• Primary Outcome: To evaluate the crestal bone level change at the implant site (mean of mesial and distal measurements) in conventional loading procedures measured at 6 months (+/- 2 weeks) post implant placement.
• Secondary Outcome: 1.Evaluation of survival rate and Buser's success criteria of individual implants 2.Evaluation of crestal bone level change at 12months(+/-4 weeks) post surgery compared to base line (surgery)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Systemic exclusion criteria 1. Patients with the systemic disease that would interfere with dental implant therapy 2. Patients with the disease which are applicable to any contraindications or principle contraindications for oral surgery procedures. 3. Patients who smoke >10 cigarettes per day. 4. Patients who have participated in another clinical research within 30 days before obtaining the consent for participating in this research, or who expect to participate in any other investigational drug or device research during the conduct of this research. 5. Patients who can not follow the instruction from principal investigator or investigator. 6. Conditions or circumstances, in the opinion of the Investigator, which would prevent completion of research participation or interfere with analysis of research results. 7. Pregnant or breastfeeding women, and women who desire to get pregnant during clinical research or who has a possibility of it. 8. Patients who are uncooperative. Dental Exclusion Criteria 1. Any untreated dental and serious periodontal lesions 2. Severe bruxing or clenching habits 3. Existing implants in the adjacent position 4. Removable dentures or un-restored tooth gaps in the opposing dentition 5. Insufficient oral-hihygiene or patients unmotivated for adequate home care 6. Probing pocket depth of ≥ 4 mm on one of the teeth immediately adjacent to the dental implant site 7. Major simultaneous augmentation procedures. 8. Patients who need a maxillary sinus lift, socket preservation, or ridge augmentation prior to implant placement. 9. Patients who received another implant placement that resulted in failure on the planned site of implant.

Related Information

• Primary Sponsor: Tokyo Medical and Dental University
• Source(s) of Monetary Support: Straumann Japan