Services Institute of Medical Sciences Lahore
Lahore, Punjab Province, 54000, Pakistan
NCT Number: NCT07274319
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
Trial opening soon.
Get Notified16 year and older
All sexes
Interventional
Not applicable
Lahore, Punjab Province, 54000, Pakistan
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
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.
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.
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:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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:
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Muhammad Hassan, BDS
CONTACT
Shanza Rehman, BDS
CONTACT
Services Institute of Medical Sciences, Pakistan
Other Gov
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