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The efficacy of Ossicure bone graft in stimulating new bone formation: A double-blind randomized controlled trial

The efficacy of Ossicure bone graft in stimulating new bone formation: A double-blind randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241224002
Enrollment
45
Registered
2024-12-24
Start date
2025-10-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

New bone formation in grafted site Post-operation pain and swelling rh-BMP Bone graft Ridge preservation

Interventions

After impacted tooth removals, the bare tooth sockets in the test group will be filled with Ossicure Bone Graft. Then the flap will be sutured using primary intention technique.,After impacted tooth r
Test material,Positive control,Negative contrl

Sponsors

National Science and Technology Development Agency
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The healthy adult patients (ASA I, II) over 18 years old of age undergo at least one of third molar surgical removal. 2. The patients have at least one of third molar impacted tooth. The tooth must be clinical missing or can be provided primary surgical wound closure after tooth removal.

Exclusion criteria

Exclusion criteria: 1. The site of impacted teeth showing signs of inflammation 2. The teeth which locate obviously involving the maxillary sinus or inferior alveolar nerve 3. The subjects who refuse to participate in the study 4. The subjects who cannot come for follow-up and taking CBCT after treatment 5. The smoking subjects 6. The subjects with the history of allergy to hypersensitivity to recombinant human Bone Morphogenetic Protein-2 and bovine Type I collagen 7. The subjects with the history of exposure to the medications which could interfere the bone repair process, for example, Bisphosphonates, RANKL inhibitors etc. and the subjects with history of radiation in head and neck area. 8. The subjects with the uncontrolled systemic diseases which could interfere the wound healing process, for example, Diabetes Miletus, Osteoporosis etc. and the subjects with the contraindicated conditions for dental treatments, for example, uncontrolled hypertension, bleeding tendency etc.. 9. Pregnant or lactating females

Design outcomes

Primary

MeasureTime frame
New bone formation 2 weeks, 2 months and 4 months Grey value in cone beam computed tomography

Secondary

MeasureTime frame
Pain 0hour, 6hour, 1 day, 2 day, 3 day ,4 day, 5 day, 6 day, 7 day 0-10 Visual analog scale,Swelling 0hour, 6hour, 1 day, 2 day, 3 day ,4 day, 5 day, 6 day, 7 day 0-10 Visual analog scale

Countries

Thailand

Contacts

Public ContactSirimanas Jiaranuchart

Chulalongkorn university

sirimanas.som@gmail.com0919289763

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026