Sagittal and Parasagittal Palatal FractureNCT07274319
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
A study testing intra arch wire stabilization technique and Transmucosal Miniplate Stabilization in people with Sagittal and Parasagittal Palatal Fracture, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sagittal and Parasagittal Palatal Fracture
- What is being tested?
- intra arch wire stabilization technique and Transmucosal Miniplate Stabilization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Age ≥16 years
- Both gender
- CT scan confirmation of a sagittal or para-sagittal palatal fracture
- Dentate patients whose first molars are intact
Who cannot join
- • Transverse or comminuted palatal fractures
- Patients with edentulous teeth
- Coagulopathies or serious systemic diseases
- Patients who decline to follow up
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Services Institute of Medical Sciences Lahore
Lahore, Punjab Province, 54000
Muhammad Hassan, BDS, +923012540601, mh1314221@gmail.com
About this study
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
Read the 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
- 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.
- 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.
- 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.
- Being tested
- intra arch wire stabilization technique, Transmucosal Miniplate Stabilization
- Keywords
- sagittal palatal fracture, parasagittal palatal fracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intra arch wire stabilization techniqueProcedure or 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 StabilizationProcedure or 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,
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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, Receives: Procedure: Transmucosal Miniplate Stabilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 4, 8 and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start1 Sep 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Sagittal and Parasagittal Palatal FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Services Institute of Medical Sciences, Pakistan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Hassan, Services Institute of Medical Sciences, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274319
- Sponsor's protocol ID
- IRB/2025/1699/SIMS
- Status last verified
- Nov 2025
- First submitted
- 27 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 11838797Cienfuegos 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.
PubMed 22132261Giri 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.
PubMed 26604472Silajiding 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.
PubMed 288656053. 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.
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.
PubMed 34667512Bhargava 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.
PubMed 29382998
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07274319
- Acronym / sponsor ID
- IRB/2025/1699/SIMS
- Keywords
- sagittal palatal fracture, parasagittal palatal fracture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Services Institute of Medical Sciences, PakistanOther government
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 10 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intra arch wire stabilization | Active comparator | Procedure: intra arch wire stabilization technique. 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. |
| Transmucosal Miniplate Stabilization | Experimental | Procedure: Transmucosal Miniplate StabilizationAnesthesia: 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, |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- • Age ≥16 years
Key exclusion criteria (4 listed)
- • Transverse or comminuted palatal fractures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intra arch wire stabilization techniqueAnesthesia: 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 or surgery | intra arch wire stabilization |
| Transmucosal Miniplate StabilizationAnesthesia: 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 or surgery | Transmucosal Miniplate Stabilization |
Primary outcome
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.
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.
1 secondary outcome
Occlusal Stability
Time frame: 4, 8 and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Results publication8. 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.
- Results publication: PubMed 11838797Broaddus 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.
- Results publication: PubMed 22132261Cienfuegos 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.
- Results publication: PubMed 26604472Giri 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.
- Results publication: PubMed 28865605Silajiding 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.
- Results publication3. 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.
- Results publication: PubMed 34667512Kumar 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.
- Results publication: PubMed 29382998Bhargava 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intra arch wire stabilization technique and Transmucosal Miniplate Stabilization in people with Sagittal and Parasagittal Palatal Fracture, run by Services Institute of Medical Sciences, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Hassan, BDS (+923012540601, mh1314221@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillo-Mandibular Molar Relation (time frame: 4,8 and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07274319, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.