Single Locking Miniplate and Two Non-locking Miniplates in the Management of Parasymphyseal Fracture

Evaluating Masticatory Biting Force After Using Single Locking Miniplate Versus Two Non-locking Miniplates in the Management of Parasymphyseal Fracture in Patients With Two-line Mandibular Fractures

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03747666

Enrollment

Registered

2018-11-20

Start date

2019-11-30

Completion date

2020-11-30

Last updated

2019-02-19

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

Conditions

Mandible Fracture

Brief summary

Evaluating the biting force after management of parasymphyseal fracture in patients with two-line mandibular fractures.

Detailed description

Evaluating the biting force after using 2.0 mm single locking miniplate versus 2.0 mm two conventional non-locking miniplates in the management of parasymphyseal fracture in patients with two-line mandibular fractures.

Interventions

PROCEDURE2.0 single locking miniplates

The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Contra-lateral unfavorable non-comminuted simple or compound mandibular fracture in the parasymphyseal and angle regions. * Fractures amenable to treatment using intra oral approach.

Exclusion criteria

* Medically compromised patients who are unfit for the procedure under general anesthesia. * Patients with comminuted fractures. * Patients with history of occlusion disturbances or skeletal malocclusion. * Patients with insufficient dentition to reproduce occlusion.

Design outcomes

Primary

Measure	Time frame	Description
Biting force	6 months	Biting force will be measured using occlusal biting force meter (Higher biting force record is better)

Secondary

Measure	Time frame	Description
Stability of fractured segments	6 weeks	Bi-manual manipulation (Binary Yes/No)
Pain intensity	10 days	Visual analog scale (0-10) 0=No pain & 10=Severe pain
Occlusion	6 months	Clinical examination (Intact/Deranged)
Infection	6 months	Clinical examination (Present/Absent)
Hardware failure	6 months	Clinical examination (Present/Absent)
Paraesthesia	6 months	Observation/Contact detection/Pin-brick nociception (0-10) 0=No sensation & 10= Normal sensation
Wound dehiscence	6 months	Clinical examination (Present/Absent)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026