| CTRI Number |
CTRI/2025/11/097542 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the pain perception and transverse changes following expansion with quad helix appliance fabricated from stainless steel (SS) and titanium molybdenum alloy (TMA) among patients with unilateral cleft lip and palate: a randomized clinical trial |
|
Scientific Title of Study
|
Comparison of the pain perception and transverse changes following expansion with quad helix appliance fabricated from stainless steel and titanium molybdenum alloy among patients with unilateral cleft lip and palate: a randomized clinical 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 Ashwin T |
| Designation |
Junior Resident (MDS) |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH |
| Address |
208, first floor, Unit of Orthodontics and dentofacial orthopaedics, Department of Oral Health Sciences Centre,
PGIMER, sector 12
Chandigarh
CHANDIGARH
160012
India |
| Phone |
6369159263 |
| Fax |
|
| Email |
aswin5550@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satinder Pal Singh |
| Designation |
Head of the Department, Professor |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH |
| Address |
208, first floor,Unit Of Orthodontics and dentofacial orthopaedics, Department of Oral Health Sciences Centre,
PGIMER, sector 12
CHANDIGARH
160012
India |
| Phone |
6369159263 |
| Fax |
|
| Email |
aswin5550@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ashwin |
| Designation |
Junior Resident (MDS) |
| Affiliation |
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH CHANDIGARH |
| Address |
208, first floor, OHSC,
PGIMER, sector 12
CHANDIGARH
160012
India |
| Phone |
6369159263 |
| Fax |
|
| Email |
aswin5550@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashwin T |
| Address |
208, first floor, Unit of Orthodontics and dentofacial orthopaedics, Dept of OHSC, PGIMER, Sector-12, Chandigarh, India-160012 |
| Type of Sponsor |
Other [student-own] |
|
|
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 Satinder Pal Singh |
Post Graduate Institute of Medical Education and Research |
208, first floor,Unit of Orthodontics and Dentofacial Orthopaedics, Department of Oral Health Sciences Centre, PGIMER, sector 12
Chandigarh
CHANDIGARH |
9815933748
drspsingh_chd@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Intituitional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q375||Cleft hard and soft palate with unilateral cleft lip, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Quadhelix appliance made of Stainless Steel |
Appliance fabricated from stainless steel alloy for 3 months of duration |
| Intervention |
Quadhelix appliance made up of Titanium molybdenum alloy |
appliance fabricated with Titanium molybdenum alloy for 3 months of duration |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
13.00 Year(s) |
| Gender |
Both |
| Details |
Patients with unilateral cleft lip and palate (Group 3) with unilateral or bilateral crossbite in need of bilateral expansion for crossbite correction
Age group: 8-13 years
Mixed dentition and permanent dentition period
Patients who consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients who had undergone previous orthodontic treatment for expansion
Craniofacial anomalies
Absence of maxillary permanent first molars
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare pain and discomfort of following expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate using Visual Analogue Scale (VAS) and Modified McGill Pain Questionnaires. |
At 4 hours, at 6 hours, at 24 hours, at 2 days and at 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the transverse skeletal changes in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on CBCT. |
pre treatment and at 3 months |
| To assess and compare the change in intercanine and intermolar width in the maxilla after 3 months of expansion using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft lip and palate on plaster study models |
at pretreatment and at 3 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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)
|
30/11/2025 |
| 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="0"
Months="3"
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
|
To compare the pain perception and transverse
dentoskeletal changes in the maxilla following expansion with Quad Helix
appliance fabricated from Stainless Steel (SS) and Titanium Molybdenum Alloy
(TMA) among the patients with unilateral cleft lip and palate. The objectives are to assess and compare pain
and discomfort of following expansion using Quad Helix appliance made from
Stainless Steel and TMA in patients
with unilateral cleft lip and palate at 4 hours, at 6 hours, 24 hours, at 2 days, at 7 days using Visual Analogue
Scale (VAS) and Modified McGill Pain Questionnaires and also to assess and compare the
transverse skeletal changes in the maxilla after 3 months of expansion
using Quad Helix appliance made from Stainless Steel and TMA in patients with unilateral cleft
lip and palate
on CBCT and to assess and compare the
change in intercanine and intermolar width in the maxilla after 3 months
of expansion using Quad Helix appliance made from Stainless Steel and TMA
in patients with unilateral cleft lip and palate on plaster study models. Total sample size is 28 with 14 in each group. Only those patients with UCLP in need of maxillary expansion will be recruited and fully informed and proper consent will be taken. The Quadhelix appliance is a non invasive appliance used for dental expansion which will be placed without any surgical intervention on a day care basis. |