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Comparative clinical study for periodonal tissue regeneration

A single center, Randomized, Patient-Evaluaor blind, Paired-Comparison Clinical study to evaluate the efficacy and safety of treatment with TDI-SM1 as compared to TXT2530 in correction of periodontium regeneration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0003004
Enrollment
25
Registered
2018-07-16
Start date
2016-06-29
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

None listed

Sponsors

Spenser Biomedical Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Healthy men and women over 20 years 2-3. Patients with bilateral, fully horizontal or mesioangular impacted, mandibular third molars 4. Present minimum 3mm-sized bony defect in the distal surface of the mandibular second molar and minimum 5mm-sized periodontal pocket depth in the distal surface of the mandibular second molar at the time of extraction 5. Patient's signed impacted consent form

Exclusion criteria

Exclusion criteria: 1. age <20 years 2. Patients with partially impacted mandibular third molar 3. Smokers 4. Patients with any systemic disease 5. Patients receiving irradiation on head and neck area 6. Patients with malignant cancer history 7. Patients with any oral mucosal disease 8. Patients with poor oral hygien 9. Pregnant and nursing mothers

Design outcomes

Secondary

MeasureTime frame
Mean of the pocket depth in the test group and controls and the height change of second molar's alveolar in lower jaw

Primary

MeasureTime frame
CAL gain measured at the rear end of the second molar of the test group and the control group evaluated by independent evaluators

Countries

Korea, Republic of

Contacts

Public ContactJu-won Kim

Hallym University Medical Center

kjw9199@hanmail.net+82-31-380-3870

Outcome results

None listed

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