CTRI Number |
CTRI/2017/02/007964 [Registered on: 27/02/2017] Trial Registered Prospectively |
Last Modified On: |
23/06/2024 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Dentistry |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Influence of orthopedic therapy in cleft lip palate patient |
Scientific Title of Study
|
3-DIMENSIONAL (3D) ASSESSMENT OF EFFECT OF ORTHOPEDIC TREATMENT MODALITIES IN NONSYNDROMIC UNILATERAL CLEFT LIP AND PALATE (NSUCLP) PATIENTS |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Shahistha Parveen |
Designation |
Reader |
Affiliation |
Yenepoya University |
Address |
R.no. 8
Department of Orthodontics Yenepoya University
University Road
Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
Phone |
09886794150 |
Fax |
|
Email |
drshahistaparveen@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Shahistha Parveen |
Designation |
Reader |
Affiliation |
Yenepoya University |
Address |
R.no.8
Department of Orthodontics Yenepoya University
University Road
Deralakatte Mangalore
Dakshina Kannada KARNATAKA 575018 India |
Phone |
09886794150 |
Fax |
|
Email |
drshahistaparveen@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Shourya Hegde |
Designation |
Reader |
Affiliation |
Yenepoya University |
Address |
Department of Orthodontics Yenepoya University Mangalore
Dakshina Kannada KARNATAKA 575018 India |
Phone |
9880488299 |
Fax |
|
Email |
mail@shourya.org |
|
Source of Monetary or Material Support
|
Yenepoya University
University Road,
Deralakatte,
Mangalore 575018. |
|
Primary Sponsor
|
Name |
Yenepoya University |
Address |
Yenepoya University
University Road,
Deralakatte,
Mangalore 575018 |
Type of Sponsor |
Research institution and hospital |
|
Details of Secondary Sponsor
|
Name |
Address |
Yenepoya University |
University Road,
Deralakatte,
Mangalore 575018. |
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Srinivas Gosla Reddy |
GSR Institute of Craniofacial Surgery |
17-1-383/55
Vinay Nagar Colony
I S Sadan
Saidabad
Hyderabad Hyderabad ANDHRA PRADESH |
9849016969
goslareddy@gmail.com |
Dr Akhter Husain |
Yenepoya University |
Department of Orthodontics
Yenepoya University
Mangalore Dakshina Kannada KARNATAKA |
9845084266
drakhter@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
GSR institute of facial and plastic Surgery |
Approved |
YenepoyaUniversitEthicsCommittee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Cleft patients undergoing skeletal correction, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Facemask with expansion appliance |
CBCT will be taken before the initiation of treatment (T0) and after the completion of orthopedic treatment (T1) to assess and compare the changes associated with different devices. |
Intervention |
Max gym with expansion appliance |
CBCT will be taken before the initiation of treatment (T0) and after the completion of orthopedic treatment (T1) to assessthe changes associated with the device. |
|
Inclusion Criteria
|
Age From |
9.00 Year(s) |
Age To |
16.00 Year(s) |
Gender |
Both |
Details |
1. Patients with NSUCLP between the age of 9-16 years.
2. Cleft patients in mixed/ permanent dentition.
3. Cleft patients with a history of primary surgery for repair of cleft lip and palate need to address sagittal discrepancy.
4. Cleft patients with constricted arch need to undergo expansion.
5. No gross facial symmetry determined clinically.
 |
|
ExclusionCriteria |
Details |
1. Syndromic cleft lip and palate patients.
2. Bilateral cleft lip and palate patients
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
To check whether intervention appliance can be used as substitute for orthopedic correction |
12months after the appliance intervention |
|
Secondary Outcome
|
Outcome |
TimePoints |
Newly introduced appliance can
generalized in all population with deficient maxilla |
Not applicable |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "36"
Final Enrollment numbers achieved (India)="36" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
01/03/2017 |
Date of Study Completion (India) |
22/02/2018 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="2" Months="6" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Non yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Cleft lip and palate is one of the commonest craniofacial disorders with incidence ranging from 1 in 300 to 1 in 2,500 live births. In India, 78 cleft infants are born every day, or 3 infants with clefts born every hour. Cleft lip and palate patients need extensive treatment from early age until adulthood. Primary surgeries have an effect on growth of the maxillofacial complex. Deficient maxilla (both in transverse and sagittal dimension) is one of the most common features of surgically corrected cleft lip and palate which is thought to be due to the presence of the scar tissue. To correct the transverse discrepancies, orthodontists often use orthopedic appliances such as expansion appliances and to correct the sagittal discrepancies, face mask is used. The combined use of expansion appliance and a facemask is a contemporary technique for maxillary protraction during growth in cleft patients. However, the use of facemask has few shortcomings such as long duration of wear and the efficacy of appliance is highly dependent on patient compliance. Max gym is a dentofacial orthopaedic apparatus, proposed to protract the maxilla using variable weights stacked upon a pulley mechanism via a maxillary splint with incorporated expansion appliances. The patient is trained to pull away from this appliance which will help in correcting maxillary deficiency in sagittal and transverse dimension. The difference between face mask and the max gym is that, the anchorage taken by the appliance is from the wall as opposed to the patient’s chin and forehead as in face mask therapy. The forces used to bring about skeletal changes in max gym are heavier and the duration of use is much lesser unlike the face mask which has lighter and continuous forces. Patient’s compliance is better as it eliminates wearing of extra oral appliance for longer duration. There is general agreement that orthopedic forces applied to the maxillary complex are more effective in growth modulation and invasive surgical procedure can be minimized/avoided at a later date. This study will assess and compare the changes in craniofacial structures by two different protraction appliances using Cone Beam Computed Tomography (CBCT). |