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

Assessment of Guided bone regeneration procedure with OssGuide® on dehiscence type bony defect; Unicenter Randomized Controlled Single-blinded Clinical Research

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0001709

Enrollment

Registered

2015-11-30

Start date

2013-09-23

Completion date

Unknown

Last updated

2019-03-11

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

Conditions

None listed

Interventions

Medical Device : 1) Experimental : Resorbable collagen membrane (OssGuide®) with Deproteinized Bovine Bone Mineral (Bio-Oss®), Device application at surgery, Duration of effica

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Ease of handling ; VAS (Visual Analogue Scale)	—

Countries

Korea, Republic of

Contacts

Public ContactJung Seok Lee

Yonsei University

cooldds@gmail.com+82-2-2228-3185

Outcome results