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Managing mandibular fractures using bone cement

Penultimate treatment line for fracture repair - A clinical trial using bone adhesive in managing fractured mandible - NIL

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/10/059291
Enrollment
24
Registered
2023-10-30
Start date
Unknown
Completion date
Unknown
Last updated
2023-11-13

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

Conditions

Health Condition 1: - Health Condition 2: T758- Other specified effects of external causes Health Condition 3: V899- Person injured in unspecified vehicle accident

Interventions

Intervention1: Bone Cement - Tetracalcium phosphate and phosphoserine (TTCP-PS): Bone cement is a novel mineral-organic comprised of tetracalcium phosphate and phosphoserine (TTCP-PS) powder which rea

Sponsors

ICMR
Lead Sponsor
Sri Ramachandra Insititute of Higher Education and Researc
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1.Subjects are above 19 years of age will be recruited. 2.Subject is diagnosed with mandibular fractures like - simple, compound fracture will be included. 3.Trauma subjects – Sports injury, slip and fall will be recruited. 4.Subjects requiring open reduction and internal fixation for mandible fractures following trauma will be included.

Exclusion criteria

Exclusion criteria: 1.Subjects Below 19 years of age. 2.Subjects with comminuted and avulsive mandible fracture. 3.Subjects with other fractured involving maxillofacial region such as craniofacial and pan facial fractures. 4.Subjects those who are not willing for the study.

Design outcomes

Primary

MeasureTime frame
To determine the effectiveness of bone adhesive in fixing reduced fracture segments compared to mini plate fixation. To evaluate the post-operative bite force 6 and 12 weeks post-operatively in the test group. To determine the central and periphery fusion of bone adhesive over fractured segment in 6th week and replacement of bone adhesive by cancellous bone after 20th week.Timepoint: Three - Four months

Secondary

MeasureTime frame
To evaluate the adverse events occurring in the test group after application of bone adhesive.Timepoint: Any time after six months

Countries

India

Contacts

Public ContactDr Jawahar Babu S

Sri Ramachandra Insititute of Higher Education and Research

naveenkumarj@sriramachandra.edu.in9884140960

Outcome results

None listed

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