“A Comparative Evaluation Of 2.0 mm Titanium Mini Plates And 3D Titanium Locking Plates In Mandibular Osteosynthesis- A Randomised Clinical Prospective Studyâ€
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- In primary outcomes it was noted that 3D plates used in patients gives increase stability, decreases time duration of surgery.
Study Overview
Brief Summary
Mandibular fractures are the second most common facial fracture following nasal fracture. The position, prominence, anatomic configuration, mobility and less bone support of the mandible make it one of the most frequent facial bones to be fractured.The treatment of symphysis/parasymphysis fractures can be divided into 2 major treatment methods: closed reduction (CR) and open reduction and internal fixation (ORIF). Miniplates have been the preferred ï¬xation method in craniomaxillofacial surgery because of their relatively small size, adaptability, ease of placement and intraoral approach.
However controversies abound with respect to rigidity and stability provided by miniplates especially in angle fractures and comminuted fractures, as they are considered as semirigid ï¬xation methods by followers of AO/ASIF.
Farmand developed 3-D plate with quadrangular design formed by joining two miniplates with interconnecting crossbars. The stability is gained over a deï¬ned surface area in three dimensions due to its conï¬guration, not by thickness or length and offers good resistance against torsional forces. Author recommended 1.0 mm thick standard plates in mandibular osteosynthesis.
To overcome the disadvantages of loosening of hardware and need of perfect adaptation of miniplates a new Internal Mini-Locking-System was developed. Since then many surgeons have been debating between the use of conventional miniplates, 3D plates and 3D locking plates in maxillofacial surgery. Nilima J. Budhraja et. al advocated that 3D locking plate is an alternative approach with a similar outcome profile to miniplates whereas Denny George et al. advocated that 3D titanium locking miniplates are better in fracture stabilization for anterior mandibular fractures when compared with conventional titanium miniplates. Previous studies encourage to carry forward the debate between conventional miniplates and 3 D locking plates requiring further research in this field.
The aim of the study is to compare the efficacy, stability and rigidity of 3D titanium locking plates with 2.0 mm titanium miniplates.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 16.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients with symphysis and parasymphysis mandibular fractures.
Exclusion Criteria
- •Patients who refuses to give consent.
- •Patients with infected fractures.
- •Communited fractures.
- •Atrophic mandible.
- •Pathological fractures.
- •ASA III & IV.
Outcomes
Primary Outcomes
In primary outcomes it was noted that 3D plates used in patients gives increase stability, decreases time duration of surgery.
Time Frame: 1 year
Secondary Outcomes
- in secondary outcomes it was noted that the bite force increase in the patients treated with 3D plates after 1 week of surgery. post op pain was minimal.(1.5 years)