| CTRI Number |
CTRI/2025/08/092722 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
08/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Jaw Expansion in Teenagers: Comparing Standard Treatment with and without Laser Therapy |
|
Scientific Title of Study
|
Evaluation of bone density and effects of mini-screw assisted rapid palatal expansion with and without low intensity laser therapy on maxilla in late adolescents. A Randomized Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aneesh Pradhan |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept No 104 Government Dental College And Hospital Medical Campus Medical Chowk Ajni Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9545521997 |
| Fax |
|
| Email |
aneesh_pradhan@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Santosh Chavan |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. No 104, Government Dental College And Hospital, Medical Campus, Medical Chowk, Ajni Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823630486 |
| Fax |
|
| Email |
drsjchavan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Santosh Chavan |
| Designation |
Professor and Head of Department |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Dept. No 104, Government Dental College And Hospital, Medical Campus, Medical Chowk, Ajni Nagpur
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9823630486 |
| Fax |
|
| Email |
drsjchavan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Orthodontics & Dentofacial Orthopaedics, Government Dental College and
Hospital Nagpur, Medical College Premises, Medical Square, Nagpur, Maharashtra 440003 |
|
|
Primary Sponsor
|
| Name |
Dr. Aneesh Pradhan |
| Address |
Dept no 104 Department of Orthodontics and Dentofacial Orthopaedics Government Dental College and Hospital Medical College Campus Ajni Nagpur 440003 |
| Type of Sponsor |
Other [Self Funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aneesh Pradhan |
Government Dental College and Hospital, Nagpur |
Dept. No 104 Department of Orthodontics and Dentofacial Orthopedics Government Dental College and Hospital Medical Campus Medical Chowk Ajni Nagpur
Nagpur
MAHARASHTRA |
9545521997
aneesh_pradhan@outlook.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital Nagpur Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Transverse Maxillary Deficiency |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Miniscrew Assisted Rapid Palatal Expansion with Low Intensity Laser Therapy |
All participants who agree to participate will provide informed consent. Pre-treatment records will include diagnostic models, lateral cephalogram, Orthopantomogram (OPG), intraoral and extraoral photographs. Treatment Protocol: Following case analysis
A tomographic image (CBCT) of the maxilla will be obtained before appliance insertion (T0).
The MARPE device will have two rigid hooks with screw holes extending from the HYRAX screw to accommodate two bone screws as well as four rigid arms soldered on the maxillary first premolars and maxillary first molars.
Following MARPE cementation, two self-drilling bone screws (2 mm diameter and 10 mm length) will be inserted perpendicularly to the centre of the screw hole under local infiltration anaesthesia. Mini-screws will be placed lateral to the midpalatal suture in the first premolar region. Activation protocol for MARPE: One full turn will be given at the moment of installation of the appliance. Two quarter turns daily will be given by patients/parents (1/4 in the morning and evening) until achieving overcorrection. This will be visualized clinically as the palatal cusp of the maxillary molars coming in the direction of the buccal cusps of the mandibular molar. After the end of activation, the appliance will be left passive in the same position for retention period of 3 months. Patients of the experimental group will be subjected to LILT sessions as
follows:
GaAlas (980 nm) semiconductor diode laser
Continuous emission mode
0.04 micrometre cylindrical quartz tip
Spot area- 0.04 micrometre
Energy per point-0.4 J
Time per point - 10 seconds.
Power - 40 mw.
Density - 10 J/cm.
Number of points- 10
Laser application protocol (total 12 sessions):
Laser fibre will be placed in contact with the mucosa of the palate.
First session: On the day of appliance insertion (Day1)
Next 4 sessions after every three days (Day 4,7,10,13)
Next 7 sessions on weekly intervals (7weeks)
Laser Application points:
(Total 10 points around the midpalatal suture)
4 Anterior points: Anterior to the screw
2 Lateral points: One point on either side of the screw
4 Posterior points: Posterior to the screw. |
| Comparator Agent |
Miniscrew Assisted Rapid Palatal Expansion without Low Intensity Laser Therapy. |
All participants who agree to participate will provide informed consent. Pre-treatment records will include diagnostic models, lateral cephalogram, Orthopantomogram (OPG), intraoral and extraoral photographs.
Treatment Protocol:
Following case analysis
A tomographic image (CBCT) of the maxilla will be obtained before appliance insertion (T0).
The MARPE device will have two rigid hooks with screw holes extending from the HYRAX screw to accommodate two bone screws as well as four rigid arms soldered on the maxillary first premolars and maxillary first molars.
Following MARPE cementation, two self-drilling bone screws (2 mm diameter and 10 mm length) will be inserted perpendicularly to the centre of the screw hole under local infiltration anaesthesia. Mini-screws will be placed lateral to the midpalatal suture in the first premolar region.
Activation protocol for MARPE:
One full turn will be given at the moment of installation of the appliance.
Two quarter turns daily will be given by patients/parents (1/4 in the morning and evening) until achieving overcorrection. This will be visualized clinically as the palatal cusp of the maxillary molars coming in the direction of the buccal cusps of the mandibular molar.
After the end of activation, the appliance will be left passive in the same position for retention period of 3 months.
After retention phase (3 months), tomographic image of the maxilla will be obtained (T1).
Bone density: Pre- and post-operative measurements at the alveolar crest and midpoint to the incisive foramen, using CBCT.
Skeletal effects: Maxillary, nasal spine, and nasal base widths measured on coronal views.
Dental effects: Changes in maxillary width for molars, premolars, and canines; alveolar tipping assessed via intermolar angle.
Data collection will be done after 90 days.
|
|
|
Inclusion Criteria
|
| Age From |
14.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients having unilateral or bilateral true skeletal posterior crossbite, constricted maxilla and lack of space in the maxilla for eruption of the permanent teeth.
|
|
| ExclusionCriteria |
| Details |
Participants with previous orthodontic treatment
Patients with craniofacial anomalies.
Patients with history of trauma to the maxilla.
Patients under use of any systemic medication.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze & compare the optical density of midpalatal suture after miniscrew assisted rapid palatal expansion with and without LILT. |
T0- Before appliance insertion at baseline
T1- After retention phase
of 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To analyze & compare the skeletal effects of miniscrew assisted rapid palatal expansion with & without LILT.
To analyze & compare the dental effects of miniscrew
assisted rapid palatal expansion with & without LILT.
|
T0- Before appliance insertion at baseline
T1- After retention phase
of 3 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study evaluates the effects of Miniscrew-Assisted Rapid Palatal Expansion (MARPE) with and without Low-Intensity Laser Therapy (LILT) in late adolescents with transverse maxillary deficiency. It uses CBCT to measure bone density, skeletal changes (maxillary and nasal widths), and dental effects (changes in maxillary width and alveolar tipping). The trial involves two groups: one with MARPE combined with LILT and the other without LILT. Laser sessions follow a defined protocol, targeting the midpalatal suture to enhance bone regeneration and expansion. Hypothesis: There is no significant difference in bone density and effects of MARPE with and without LILT in late adolescents with transverse maxillary deficiency.
|