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

NCT07274319 | Not Yet Recruiting DMC

• 1 other identifier: IRB/2025/1699/SIMS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sagittal and Parasagittal Palatal Fracture

Keywords

sagittal palatal fracture; parasagittal palatal fracture

Outcome Measures

Primary Outcomes (2)

• 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.

  4,8 and 12 weeks

• 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.

  4, 8, and 12 weeks

Secondary Outcomes (1)

• Occlusal Stability

  4, 8 and 12 weeks

Study Arms (2)

intra arch wire stabilization

ACTIVE COMPARATOR

. 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

Transmucosal Miniplate Stabilization

EXPERIMENTAL

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

Interventions

intra arch wire stabilization technique PROCEDURE

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.

intra arch wire stabilization

Transmucosal Miniplate Stabilization PROCEDURE

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,

Transmucosal Miniplate Stabilization

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥16 years
• Both gender
• CT scan confirmation of a sagittal or para-sagittal palatal fracture
• Dentate patients whose first molars are intact

You may not qualify if:

• Transverse or comminuted palatal fractures
• Patients with edentulous teeth
• Coagulopathies or serious systemic diseases
• Patients who decline to follow up

Sponsors & Collaborators

• Services Institute of Medical Sciences, Pakistan: lead

Study Sites (1)

Services Institute of Medical Sciences Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

• 8. Bej A, Mishra S, Padhiary SK, Sahoo S, Kadam DR. A Prospective Study on Comparison of the Effectiveness of Transmucosal Plate and Intra-arch Wire Fixation in the Management of Palatal Fracture. Journal of Maxillofacial and Oral Surgery. 2025 Jun 8:1-6.

  RESULT

• Broaddus WC, Holloway KL, Winters CJ, Bullock MR, Graham RS, Mathern BE, Ward JD, Young HF. Titanium miniplates or stainless steel wire for cranial fixation: a prospective randomized comparison. J Neurosurg. 2002 Feb;96(2):244-7. doi: 10.3171/jns.2002.96.2.0244.

  PMID: 11838797 RESULT

• Cienfuegos R, Sierra E, Ortiz B, Fernandez G. Treatment of Palatal Fractures by Osteosynthesis with 2.0-mm Locking Plates as External Fixator. Craniomaxillofac Trauma Reconstr. 2010 Dec;3(4):223-30. doi: 10.1055/s-0030-1268519.

  PMID: 22132261 RESULT

• Giri KY, Sahu P, Rastogi S, Dandriyal R, Mall S, Singh AP, Indra B NP, Pratap Singh H. Bite Force Evaluation of Conventional Plating System Versus Locking Plating System for Mandibular Fracture. J Maxillofac Oral Surg. 2015 Dec;14(4):972-8. doi: 10.1007/s12663-015-0764-7. Epub 2015 Mar 10.

  PMID: 26604472 RESULT

• Silajiding K, Wusiman P, Yusufu B, Moming A. Three dimensional versus standard miniplate fixation in the management of mandibular fractures: A meta-analysis of randomized controlled trials. Kaohsiung J Med Sci. 2017 Sep;33(9):464-472. doi: 10.1016/j.kjms.2017.05.001. Epub 2017 Jun 29.

  PMID: 28865605 RESULT

• 3. Sharma D, Khan TA, Tripathi GM, Mishra A. Epidemiology, Pattern, and Management of Midsagittal and Parasagittal Palatal Fractures through Placement of Intra-arch Wire. Journal of Surgical Specialties and Rural Practice. 2023 Jan 1;4(1):28-32.

  RESULT

• Kumar U, Jain P. Sagittal Maxillary Fracture: Diagnosis and Management. Indian J Plast Surg. 2021 Aug 2;54(3):284-288. doi: 10.1055/s-0041-1729665. eCollection 2021 Sep.

  PMID: 34667512 RESULT

• Bhargava D, Thomas S, Pandey A. Reduction of Palatal Midline and Para-Midline Fractures Using Intra-arch Wire Fixation Versus Transmucosal Miniplate Stabilization: Prospective Randomized Clinical Study to Evaluate Postoperative Occlusion. J Maxillofac Oral Surg. 2018 Mar;17(1):71-74. doi: 10.1007/s12663-016-0980-9. Epub 2016 Oct 21.

  PMID: 29382998 RESULT

Central Study Contacts

Muhammad Hassan, BDS

CONTACT

+923012540601; mh1314221@gmail.com

Shanza Rehman, BDS

CONTACT

+923368821994; shanzarehman175@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Muhammad Hassan

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 10, 2025
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)