MedPath

Assessment of Guided bone regeneration procedure with OssGuide® on dehiscence type bony defect

Not Applicable
Completed
Conditions
Diseases of the digestive system
Registration Number
KCT0001709
Lead Sponsor
Bioland
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
30
Inclusion Criteria

1. Healthy men and women over 20 years of age
2. Patients who are needed of one or more implants restoration in the maxillary or mandible
3. Patients who can respond in good faith on a regular recall until termination of clinical trial
4. Patients who fully understand the details of the trial and obtain a written consent
5. More than at least 3mm of the vertical height of bone defect after implant placement, when it is possible to ensure the primary stability

Exclusion Criteria

1. Patients with uncontrolled diabetes
2. Patients with uncontrolled hypertension
3. Heavy smoker (= 20 cigarettes/day)
4. Patients who are taking medication or hormones that affect bone or soft tissue metabolism
5. Patients with history of radiation therapy or chemotherapy due to malignant neoplasm
6. Pregnant or lactating women, or women who are taking contraceptives
7. Patients who have or are suspected of having mental diseases
8. Participation in another clinical trial
9. Patients with oral cavity or severe soft tissue diseases, or who are exist untreated infectious agent such as periodontitis
10. Patients with allergic or hypersensitivity reactions to implant, bone graft material and barrier membrane
11. Immediate implant placemet after tooth extraction

Study & Design

Study Type
Interventional Study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Absorption rate of implanted bone graft material using a Cone-beam CT;Volume measurements of grafting material using a Cone-beam CT ;Comparison of measurements of bone defects during surgery and re-entry ;Adverse and inflammatory reactions
Secondary Outcome Measures
NameTimeMethod
Ease of handling ; VAS (Visual Analogue Scale)
© Copyright 2025. All Rights Reserved by MedPath