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Clinical study of bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement

Clinical study of bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement - Nongrafted sinus lift using a PLLA mesh plate device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028915
Enrollment
15
Registered
2017-08-30
Start date
2017-11-30
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Tooth loss

Interventions

Maxillary sinus lift is performed by sinus membrane elevation using a bioresorbable unsintered hydroxyapatite combined with poly L-lactide (HA/PLLA) mesh plate device(Super FIXSORB-MX, TEIJIN MEDICAL

Sponsors

Department of Oral and Maxillofacial Surgery Saitama Medical Center, Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Subjects are competent to consent, keep the rules of the study and are able to report self-condition. 2. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study. 3. Patient must show atrophy in the posterior maxilla with healthy sinuses that are judged to need sinus augmentation procedure, but with residual alveolar crest height of 2 mm or greater.

Exclusion criteria

Exclusion criteria: 1. Previous history of surgery and/or pathology in the maxillary sinuses. 2. Severe thickening of sinus membrane and pathology of neighboring teeth. 3. Subjects who are inadequate for enrollment judged by the investigator

Design outcomes

Primary

MeasureTime frame
1. Implant survival rate 2. Preoperative and postoperative alveolar crest height

Secondary

MeasureTime frame
1. Presence of Schneiderian membrane perforation 2. Patients demographics 3. Position and dimension of the implants 4. Complications 5. Marginal bone loss

Countries

Japan

Contacts

Public ContactTakahiro Kaneko

Saitama Medical Center, Saitama Medical University Department of Oral and Maxillofacial Surgery

t_kaneko@saitama-med.ac.jp049-228-3687

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026