EFFICACY OF TRANSMUCOSAL MINIPLEITE STABILIZATION TECHNIQUE VERSUS INTRA-ARCH WIRE STABILIZATION TECHNIQUE FOR FIXATION OF SAGITTAL & PARA-SAGITTAL TYPES OF PALATAL FRACTURES IN TERMS OF INTRA-ARCH MOLAR DISTANCE & MAXILLO-MANDIBULAR MOLAR RELATION

Services Institute of Medical Sciences, Pakistan

Status: Begins enrollment in 6 months

Conditions: Sagittal and Parasagittal Palatal Fracture

Treatments: Procedure: Transmucosal Miniplate Stabilization; Procedure: intra arch wire stabilization technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07274319

IRB/2025/1699/SIMS

Details and patient eligibility

About

The purpose of this study is to reduce uncertainity around decision making regarding use of transmucosal miniplate stabilization technique in place of intra-arch wire stabilization technique to get better outcomes. It will help establish future guidelines for sagittal and para-sagittal types of palatal fracture treatment Under general anasthesia wires will be passed between molars of both sides for palatal fracture reduction or fracture will be reduced by applying plate at fracture site

Full description

Patients who present to a tertiary care oral and maxillofacial surgery department with sagittal or parasagittal palatal fractures will have their data prospectively gathered. Participants will be randomized to either the intra-arch wire stabilization group or the transmucosal miniplate stabilization group after providing their informed consent and undergoing eligibility screening.

Details of the Surgical Procedure

1. Preoperative Assessment:

   A thorough clinical examination that includes a palatal integrity assessment and an occlusal evaluation.

   To verify the kind (sagittal or para-sagittal) and extent of a palatal fracture, radiological imaging (CT or 3D CBCT scans) will be used along with imprints of the mandible and maxilla for model analysis and preoperative anesthetic evaluation and preventative antibiotics.

2. Technique for Intra-Arch Wire Stabilization:

   Anesthesia:

   Nasoendotracheal intubation combined with general anesthesia.

   Access via Surgery:

   The fracture line is identified.

   Positioning the Wire:

   Around the necks of the rear palatal teeth, stainless steel wires (often 26 or 28 gauge) are passed, commonly from molar to molar or second premolar to second premolar.

   To stabilize the segments and guarantee appropriate fracture reduction, the wires are crossed over the palate (transpalatal wiring).

   Alignment of Occlusal Space:

   To guarantee that the molar connection is preserved during tightening, temporary intermaxillary fixation (IMF) or occlusal guiding are employed.

   Occlusion is rechecked for correctness after stabilization.

   Care Following Surgery:

   oral hygiene guidelines, analgesics, and antibiotics. One to two weeks of a liquid-to-soft diet. Wires are removed in an outpatient setting and may stay in place for four to six weeks.

3. Technique for Transmucosal Miniplate Stabilization:

Anesthesia:

Nasoendotracheal intubation for general anesthesia.

Adapting Plates:

To fit the palatal curvature, a 1.5 or 2.0 mm titanium miniplate is molded.The plate is adapted over the fracture site and placed over the palate tissue.

Fixing the Plate:

The miniplate is attached to the palatal bone on each side of the fracture using miniscrews (4-6 mm).

Intraoperative check-bite or temporary intermaxillary fixation are used to guide occlusion.

Healing of Wounds:

Because there is little disturbance, mucosal healing happens quickly.

Care Following Surgery:

standard regimen of analgesics and antibiotics. Rinses with chlorhexidine and soft diet. Unless exposed or symptomatic, the miniplate is often kept in place; a second surgery is not necessary unless it is necessary.

Monitoring of Follow-Up and Outcomes:

• Frequent follow-up appointments at 1, 2, 4, and 6 weeks.
• intra-arch molar distance measurement with model analysis or digital calipers.
• Using bite analysis or occlusal markers, the molar connection is evaluated.
• Using follow-up radiographs and clinical stability, fracture healing is evaluated.

Demographic information, trauma history, fracture classification (as verified by CT imaging), and the baseline intra-arch molar distance measured with digital calipers will all be included in the preoperative data. Standard occlusion classification will be used to clinically document baseline maxillo-mandibular molar relationships. Trained maxillofacial surgeons will carry out the designated surgical procedure according to a defined methodology.

Assessments for postoperative follow-up will be carried out at 1, 4, 8, and 12 weeks. Clinical assessments of occlusal stability, intra-arch molar distance measurements, postoperative complications, and the need for occlusal correction will all be recorded at each visit. To guarantee data quality, data will be entered using structured forms and checked for accuracy by a second reviewer.

Enrollment: 40 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Age ≥16 years

  • Both gender
  • CT scan confirmation of a sagittal or para-sagittal palatal fracture
  • Dentate patients whose first molars are intact

Exclusion criteria

• • Transverse or comminuted palatal fractures

  • Patients with edentulous teeth
  • Coagulopathies or serious systemic diseases
  • Patients who decline to follow up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

intra arch wire stabilization

Active Comparator group

Description:

. Technique for Intra-Arch Wire Stabilization: Anesthesia: Nasoendotracheal intubation combined with general anesthesia. Access via Surgery: The fracture line is identified. Positioning the Wire: Around the necks of the rear palatal teeth, stainless steel wires (often 26 or 28 gauge) are passed, commonly from molar to molar or second premolar to second premolar. To stabilize the segments and guarantee appropriate fracture reduction, the wires are crossed over the palate (transpalatal wiring). Alignment of Occlusal Space: To guarantee that the molar connection is preserved during tightening, temporary intermaxillary fixation (IMF) or occlusal guiding are employed. Occlusion is rechecked for correctness after stabilization. Care Following Surgery: oral hygiene guidelines, analgesics, and antibiotics. One to two weeks of a liquid-to-soft diet. Wires are removed in an outpatient setting and may stay in place for four to six weeks.

Treatment:

Procedure: intra arch wire stabilization technique

Transmucosal Miniplate Stabilization

Experimental group

Description:

Anesthesia: Nasoendotracheal intubation for general anesthesia. Adapting Plates: To fit the palatal curvature, a 1.5 or 2.0 mm titanium miniplate is molded.The plate is adapted over the fracture site and placed over the palate tissue. Fixing the Plate: The miniplate is attached to the palatal bone on each side of the fracture using miniscrews (4-6 mm). Intraoperative check-bite or temporary intermaxillary fixation are used to guide occlusion. Healing of Wounds: Because there is little disturbance, mucosal healing happens quickly. Care Following Surgery: standard regimen of analgesics and antibiotics. Rinses with chlorhexidine and soft diet. Unless exposed or symptomatic, the miniplate is often kept in place; a second surgery is not necessary unless it is necessary. Monitoring of Follow-Up and Outcomes: * Frequent follow-up appointments at 1, 2, 4, and 6 weeks. * intra-arch molar distance measurement with model analysis or digital calipers. * Using bite analysis or occlusal markers,

Treatment:

Procedure: Transmucosal Miniplate Stabilization