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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorServices Institute of Medical Sciences, Pakistan

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Age ≥16 years

Both gender

CT scan confirmation of a sagittal or para-sagittal palatal fracture

Dentate patients whose first molars are intact

Disqualifiers

• Transverse or comminuted palatal fractures

Patients with edentulous teeth

Coagulopathies or serious systemic diseases

Patients who decline to follow up

Trial design

Design model

Parallel

Treatments tested in this trial

  • intra arch wire stabilization technique

    Procedure/Surgery

    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.

  • Transmucosal Miniplate Stabilization

    Procedure/Surgery

    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 groups

40 Participants
are divided into 2 treatment groups
Group A: intra arch wire stabilizationActive comparator 1 intervention
Group B: Transmucosal Miniplate StabilizationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Maxillo-Mandibular Molar Relation

The upper and lower first molars' occlusal alignment is evaluated both clinically, to classify them as normal, mildly malocclusion, or severely malocclusion. Molar relationships are compared to Angle's classification by visual clinical assessment. The degree of malocclusion is determined by changes from before to after surgery.

Time frame
4,8 and 12 weeks
2

Intra-Arch Molar Distance

Before and after surgery, the inter-molar distance between the maxillary first molars was measured in millimeters using a digital caliper. measured using a digital caliper across the first molars' mesiobuccal cusp points before and after surgery; a change signifies collapse or widening of the arch.

Time frame
4, 8, and 12 weeks

Secondary outcomes

1

Occlusal Stability

Over the course of eight to twelve weeks, the postoperative maintenance of the pre-injury occlusion without deviation or malalignment was evaluated. clinically assessed at every follow-up appointment (often at 4, 8, and 12 weeks); stability is verified if the occlusion doesn't alter in terms of functionality or appearance.

Time frame
4, 8 and 12 weeks

Other outcomes

Sponsors and contacts

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