KCT0001731
Completed
未知
Ability of new bone formation of allogenous graft material(THE Graft) and Bio-oss in sinus augmentation : Multicenter comparative clinical study.
Yonseit University Health System, Dental Hospital0 sites22 target enrollmentTBD
ConditionsDiseases of the digestive system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the digestive system
- Sponsor
- Yonseit University Health System, Dental Hospital
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Age 19 or older
- •2\) Need maxillary sinuses floor augmentation before implantation operation for single or multiple numbers of tooth
- •3\) By result of panorama radiography and computed tomography, whose actual height of residual bone in lateral\-posterior segment is 1mm \< 6mm
- •4\) Nonsmoking or smoking less than 10 cigarette for a day
- •5\) Those who can understand and follow the instruction through the clinical trial period
- •6\) Those who voluntarily participate to the trial and signed the agreement
Exclusion Criteria
- •1\)Those who has taken for has possibility to take medication that interfere bone formation within 2 weeks from the time of screening (e.g. Adrenocortical hormones, etc.) or throughout trial period.
- •2\)Those who has taken oral or injectable rheumatism therapeutics including immunosuppressive within 2 weeks from the time of screening.
- •3\)Who has hypersensitivity history with porcine bone and anorganic bovine bone
- •4\)Patients with uncontrolled diabetes or hypertension or blood clotting tunes
- •5\)Patients with a maxillary sinus or uncontrolled periodontal disease
- •6\)Patients with intraoral skin disease or lesions (e.g. erosive lichen planus, erosive lichen planus, ulcer, malignant tumor, mouth ulcer, etc.)
- •7\)Who has history of intraoral radiation therapy
- •8\)Patients who has history of treatment with oral or injectable bisphosphonate base osteoporosis treatment more than 3 months or who is current under the treatment. (For exception that according to American Association of Oral and Maxillofacial Surgeons(AAOMS) standard, who stopped the treatment within 3 months and who has CTx level 0\.150ng/ml can participate the clinical trial)
- •9\)Among the control and experimental group, who is applicable of at least one of the following conditions
- •A.Who has experience with bone graft and/or implantation
Outcomes
Primary Outcomes
Not specified
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