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Multicenter and comparative clinical trial for assessing the new bone formation of domestic alloplastic grafts for peri-implant bone defects

Multicenter and comparative clinical trial for assessing the new bone formation of domestic alloplastic grafts (Bone Matrix I) for peri-implant bone defects

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0006428
Enrollment
60
Registered
2021-08-06
Start date
2021-02-15
Completion date
Unknown
Last updated
2023-05-30

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

Conditions

None listed

Interventions

Procedure/Surgery : Implant surgery with GBR was conducted by three board-certified periodontists at one of the three dental hospitals. After the mucoperiosteal flaps were fully elevated under local a

Sponsors

Wonkwang University Daejeon Dental Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Over 20 years of age. 2. Presence of intrabony and buccal dehiscence defects after implant placement (=1 mm). 3. Proper oral hygiene and stable periodontal status which is suitable for implant surgery. 4. Having given their informed consent in accordance with IRB guidelines.

Exclusion criteria

Exclusion criteria: 1. Current severe smokers (=20 cigarettes/day). 2. Taking medicines that interfere with bone formation within two weeks before screening. 3. Oral or injectable rheumatoid arthritis medication including immunosuppressants within 2 weeks before screening. 4. Oral or injectable bisphosphonate therapy for more than 3 months before screening. 5. History of hypersensitivity to hydroxyapatite or de-mineralized bovine bone. 6. Uncontrolled diabetes or hypertension. 7. Have received radiation therapy for head and neck cancers. 8. Pregnant or breastfeeding women. 9. Dependent on alcohol or drugs. 10. Poor oral hygiene and uncontrolled periodontal disease.

Design outcomes

Primary

MeasureTime frame
Changes of horizontal thickness of the augmented site

Secondary

MeasureTime frame
Changes of defect width and height;Outcome of histologic assessments (newly formed bone area and residual bone graft biomaterial);Subjective postoperative discomfort ;Wound healing outcomes

Countries

Korea, Republic of

Contacts

Public ContactJae-Hong Lee

Wonkwang University Daejeon Dental Hospital

ljaehong@gmail.com+82-42-366-1141

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 10, 2026