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Evaluation of Clinical efficacy of TissueMax : Multicenter Randomized Clinical Trial

Evaluation of Clinical efficacy of TissueMax : Multicenter Randomized Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002213
Enrollment
70
Registered
2017-02-07
Start date
2017-02-28
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 : Comparison of vertical GBR(Guided bone regeneration) after soft tissue expansion using vertical GBR and TissueMax in patients with severe alveolar bone atrophy

Sponsors

Ewha Womans University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult patients whose age is over 20 under 75 years of age and whose jaw growth has been completed 2) A patient who had two or more teeth missing in the upper and lower jaws, who underwent bone grafting and planned implant placement 3) Non-smoker 4) Patients who agreed to participate in the clinical trial and signed the patient consent form

Exclusion criteria

Exclusion criteria: 1) Pregnant woman 2) Patients with metabolic disease (such as uncontrolled diabetes) 3) Patients taking medication that can affect bone metabolism - bisphosphonate, rhPTH, denosumab, etc 4) Patients with uncontrolled gingivitis, periodontitis, and dental caries 5) Patients who have undergone radiation therapy at the procedure site 6) Patients with hemorrhagic disease or needing anticoagulants 7) Patients with allergies to implant materials 8) Smoker 9) If the examiner determines that participation in the clinical trial is inadequate because it may affect other ethical or clinical trial results

Design outcomes

Primary

MeasureTime frame
Amount of Bone volume & Vertical height of alveolar bone;Amount of augmented tissue volume

Secondary

MeasureTime frame
Width of Attached Gingiva;Width of Soft tissue ;MicroCT and Histological Analysis

Countries

Korea, Republic of

Contacts

Public ContactSeon-Yeong Kim

Ewha Womans University Medical Center

kseon4545@ewhain.net+82-2-2650-5903

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026