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CTRI Number  CTRI/2024/04/066030 [Registered on: 19/04/2024] Trial Registered Prospectively
Last Modified On: 15/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Salivary Alkaline Phosphatase levels during single step vs two step Twin Block in growing children 
Scientific Title of Study   Comparative evaluation of Salivary Alkaline Phosphatase levels during single step vs two step mandibular advancement with Twin Block in growing children – 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  Priyanka Badu 
Designation  PG student 
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department of Orthodontics Government Dental College and Hospital Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9010578993  
Fax    
Email  badupriyanka97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Wasundhara A. Bhad 
Designation  Professor and Head of the Department  
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department of Orthodontics Government Dental College and Hospital Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9890227819  
Fax    
Email  wasundhara.bhad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Priyanka Badu 
Designation  PG student  
Affiliation  Government Dental College and Hospital Nagpur 
Address  Department of Orthodontics Government Dental College and Hospital Nagpur

Nagpur
MAHARASHTRA
440003
India 
Phone  9010578993  
Fax    
Email  badupriyanka97@gmail.com  
 
Source of Monetary or Material Support  
Government Dental college and hospital Nagpur 
 
Primary Sponsor  
Name  Dr Priyanka Badu 
Address  Dept Of Orthodontics, Government Dental College & Hospital, Medical Square, Nagpur-440003 
Type of Sponsor  Other [self funded] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Priyanka Badu  Government Dental College and Hospital Nagpur  Room no 104 Department of Orthodontics and Dentofacial Orthopedics Government Dental College and Hospital Nagpur
Nagpur
MAHARASHTRA 		 9010578993

badupriyanka97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Dental College and Hospital Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R930||Abnormal findings on diagnostic imaging of skull and head, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Twin Block  Twin block treatment with single step advancement for 6 months 
Comparator Agent  Twin block  Twin block treatment with two step advancement for 6 months 
 
Inclusion Criteria  
Age From  11.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Clinically
No previous history of any orthodontic treatment.
Each subject with a full cusp class II relationship bilaterally with convex facial profile.
The overjet should be more than than 7 mm.
VTO improved with anterior positioning of mandible.
Radiographically:
ANB angle more than 4 degrees with favourable growth pattern.
Subjects who are at accelerated phase of pubertal growth spurt (CVMI stage-3), MP3-FG and MP3- G stage.

 
 
ExclusionCriteria 
Details  Syndromic cases.
Children with following disorders –
A) Disorders of Bone metabolism.
B) Hepatobiliary disorders.
C) Systemic Inflammatory diseases.
Children with compromised oral hygiene.
Children taking drugs that can alter salivary flow.
 
 
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 the levels of salivary alkaline phosphatase during single step vs two step advancement of mandible using twin block in growing skeletal class II children.  Baseline salivary ALP levels prior to twin block delivery, 1 month, 2months, 3 months, 4 months, 5 months, 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Assess and compare skeletal and dentoalveolar effects of twin block therapy with a single step vs two step mandibular advancement.
2. Correlation of salivary alkaline phosphatase levels with skeletal effects.
 		 Every month for 6 months 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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 4 
Date of First Enrollment (India)   26/04/2024 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [badupriyanka97@gmail.com].

  6. For how long will this data be available start date provided 29-04-2025 and end date provided 29-04-2035?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Class II functional appliances are indicated in the correction of mandibular deficiencies as they allow mandibular postural changes by holding the mandible forward and/or downward. The desired skeletal and dental changes during functional therapy can be attributed to various chemical markers of bone remodelling. Alkaline phosphatase is a known chemical biomarker of bone turnover during fixed and functional orthodontic treatment. The aim of the study is to assess the levels of salivary alkaline phosphatase during single step vs two step mandibular advancement with twin block in growing skeletal class II children.

 

 
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