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

November 27, 2025 updated by: Muhammad Hassan, Services Institute of Medical Sciences, Pakistan
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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Services Institute of Medical Sciences Lahore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intra arch wire stabilization

. 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.
Procedure: intra arch wire stabilization technique

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.
Experimental: 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,
Procedure: 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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillo-Mandibular Molar Relation
Time Frame: 4,8 and 12 weeks
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.
4,8 and 12 weeks
Intra-Arch Molar Distance
Time Frame: 4, 8, and 12 weeks
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.
4, 8, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occlusal Stability
Time Frame: 4, 8 and 12 weeks
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.
4, 8 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

November 27, 2025

First Posted (Actual)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 10, 2025

Last Update Submitted That Met QC Criteria

November 27, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRB/2025/1699/SIMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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