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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

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 - A clinical research of SLA/TL implant

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007740
Enrollment
40
Registered
2012-04-13
Start date
2012-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Single Tooth Gaps in the pre-molar and molar region

Interventions

Standerdized X-ray

Sponsors

Tokyo Medical and Dental University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Patients must have voluntarily signed the informed consent form before any research related action. 2.Males and females with at least 20 years of age. 3.Single tooth gaps in molar or premolar in the mandible or maxilla 4.Adequate oral hygiene level 5.Bone quality I-III and quantity at the implant site to permit the insertion of the SLA/TL Implant. 6.Substantially healed extraction sockets

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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)

Countries

Japan

Contacts

Public ContactMakoto Shiota

Tokyo Medical and Dental University Oral Implantology & Regenerative Dental Medicine

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026