Patients with the single tooth loss in molar or premolar in the maxilla or mandible who are candidate for the dental implantation
Conditions
Interventions
Conventional loading
Early loading
Sponsors
Straumann Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects must have voluntarily signed the informed consent form before any study 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 modSLA Implant 6.Substantially healed (at least 16 weeks after tooth extraction) extraction sockets
Exclusion criteria
Exclusion criteria: Systemic exclusion criteria 1. Patients with the systemic disease that would interfere with dental implant therapy (Blood poisoning, weakened immune system, diabetes mellitus, etc--) 2. Patients with the following disease which are applicable to any contraindi-cations or principle contraindications for oral surgery procedures 2-1. Patients who are suffering from a serious internal medical problem such as cardiac infraction or cerebral infraction, uncontrollable endo-crine disorders 2-2. Patients who are suffering from a metabolic bone disease, tem-poromandibular joint disorders, maxillary and mandibular growth not completed, treatable changes in the oral mucosa, local root remnants, xerostomia, patients on bisphosphonate medication 2-3. Patients who are suffering from an inadequate wound healing ca-pacity, prolonged therapy-resistant functional disorders, illnesses re-quiring periodic use of steroids, and who has an irradiation history 2-4. Patients who are having an uncontrolled bleeding disorders, antico-agulation drugs/hemorrhagic diatheses 2-5. Patients who are suffering from psychoses, drug or alcohol abuse, titanium allergy 3. Patients who smoke >10 cigarettes per day 4. Subjects who have participated in another clinical trial within 30 days be-fore obtaining the consent for participating in this trial, or who expect to participate in any other investigational drug or device study during the conduct of this trial 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 study participation or interfere with analysis of study results 7.Pregnant or breastfeeding women, and women who desire to get preg-nant during clinical study or who has a possibility of it 8.Patients who are uncooperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Crestal bone level change at the implant site (mean of mesial and distal measurements) in early and conventional loading procedures measured at 6 months (+/-2 weeks) post implant placement | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of survival and success rates of indivisual implants 2. Evaluation of crestal bone level change at 12 months ((+/-4 weeks) post-surgery compared to baseline (surgery) 3. Evaluation of patient satisfaction | — |
Countries
Japan
Contacts
Public ContactEisaku WATANABE
Straumann Japan K.K. Regulatory&Comliance Clinical Reseach
Outcome results
None listed