Randomized, controlled, clinical trial to demonstrate non-inferiority of early loading compared to conventional loading of modSLA Implants placed in single tooth gaps
- Conditions
- Patients with the single tooth loss in molar or premolar in the maxilla or mandible who are candidate for the dental implantation
- Registration Number
- JPRN-UMIN000013353
- Lead Sponsor
- Straumann Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 74
Not provided
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
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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