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CTRI Number  CTRI/2024/03/063875 [Registered on: 08/03/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Bone deposition and resorption in responds to pulling back of teeth in orthodontic extraction patient 
Scientific Title of Study   Cortical Bone Remodelling Response to Maxillary Incisor Retraction in Orthodontic Extraction Patients: A Cone Beam Computed Tomography Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Angousana Arambam 
Designation  post gratuate 
Affiliation  Rjasthan University of Health Science 
Address  Department of orthodontic and dentofacial orthopedic, room number 3, Surendera dental college and research institute, HH garden ,power house road

Ganganagar
RAJASTHAN
335001
India 
Phone  09863253542  
Fax    
Email  angouarambamz@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Eenal Bhambri 
Designation  professor and head 
Affiliation  Rajasthan University and Health Science 
Address  Surendera Dental College and Research Institute HH Gardens, power house road, Sri Ganganagar
Surendera Dental College and Research Institute HH Gardens, power house road, Sri Ganganagar Rajasthan 335001
Ganganagar
RAJASTHAN
335001
India 
Phone  8769829700  
Fax    
Email  dreenal700@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Angousana Arambam 
Designation  post gratuate 
Affiliation  Rajasthan University and Health Science 
Address  department of orthodontic and dentofacial orthopedic ,room number 3,surendera dental college and research institute, HH garden ,power house road

Ganganagar
RAJASTHAN
335001
India 
Phone  09863253542  
Fax    
Email  angouarambamz@gmail.com  
 
Source of Monetary or Material Support  
Dept of Orthodontic and Dentofacial Orthopedic Surendera Dental College and Research Institute 
 
Primary Sponsor  
Name  Dr Angousana Arambam 
Address  Surendera Dental College and Research Institute H.H Garden ,Power House Road,Sri Ganganagar , Rajasthan 335001 
Type of Sponsor  Other [self] 
 
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 ANGOUSANA ARAMBAM  SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE  Department of orthodontics and dentofacial orthopedics ,surendera dental college HH Gardens, power house road, Sri Ganganagar 335001
Ganganagar
RAJASTHAN 
09863253542

angouarambamz@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETICAL COMMITTEE SURENDERA DENTAL COLLEGE AND RESEARCH INSTITUTE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  PATIENT OPTING REGULAR ORTHODONTIC TREATMENT 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  • Patients whose age range is 15-25 years.
• Patients with bimaxillary dentoalveolar protrusion or Angle’s class II division 1 malocclusion requiring extraction of 1st premolar.
• Maximum to moderate anchorage cases will be considered.
• The removal of bilateral maxillary first premolars during the orthodontic treatment followed by en masse retraction.
• No evidence of periodontal or gingival problems at the beginning of orthodontic treatment
• No history of trauma to the maxillary and mandibular anterior teeth.
• Good general and oral health and no use of anti-inflammatory drugs for at least 6 months before or during orthodontic treatment.
• Pretreatment (T0) and posttreatment (T1) CBCT scans
 
 
ExclusionCriteria 
Details  • Root length (the distance from the cementoenamel junction to apex) of maxillary incisors was <9 mm in T0 CBCT, and
• Low CBCT image quality, the cortical bone and root could not be defined accurately.
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To check the cortical bone remodelling after retraction of maxillary central incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary lateral incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary canine in orthodontic treatment.
To evaluate the efficacy of CBCT in detection of bone remodelling and tooth movement in pre-retraction and post retraction.
 
baseline and at six months
 
 
Secondary Outcome  
Outcome  TimePoints 
To check the cortical bone remodelling after retraction of maxillary central incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary lateral incisors in orthodontic treatment.
To check the cortical bone remodelling after retraction of maxillary canine in orthodontic treatment.
To evaluate the efficacy of CBCT in detection of bone remodelling & tooth movement in pre-retraction & post retraction. 
baseline & at six months 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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   N/A 
Date of First Enrollment (India)   15/03/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

AIM:

To explore the labial and palatal cortical bone remodelling and tooth movement measured at different root levels of retracted maxillary incisors.

7 OBJECTIVES:

1)     To check the cortical bone remodelling after retraction of maxillary central incisors in orthodontic treatment.

2)     To check the cortical bone remodelling after retraction of maxillary lateral incisors in orthodontic treatment.

3)     To check the cortical bone remodelling after retraction of maxillary canine in orthodontic treatment.

4)     To evaluate the efficacy of CBCT in detection of bone remodelling and tooth movement in pre-retraction and post retraction.

  Materials:

In this study, following armamentarium will be required

·       CBCT scans (Vatech A-9 machine).

m   METHODLOGY

Apart from routine radiographs, pretreatment CBCT scan will be taken for all subjects. All the selected subjects will require bilateral extraction of premolars.

      Orthodontic treatment protocol for all the patients will be bonding with metal MBT(Leone) prescription of 0.022- 0.028 inch and transbond XT. All the indicated first premolars will be extracted and alignment and levelling will be performed using 0.014-0.016-inch NiTi arch wires.  This will progress to 0.019-0.025-inch stainless steel wires and en-masse retraction of maxillary anterior teeth will be performed using sliding mechanics. The six maxillary anterior teeth will be consolidated by the figure of 8 ligatures and NiTi closed coil springs of either 9 or12 mm length will be used from canine to molar to retract the maxillary anterior with a constant force of 150 g on both sides.

Post retraction CBCT (T1) scan will be taken for maxillary anterior (including canines) of all the subjects.

The T0 and T1 CBCT scans will be opened in WinRAR Software version 6.24; Vatech A-9 machine and the slices (T0) will be used to outline the buccolingual border of the alveolar bone and incisor edge. The sketch and slice (T1) will be merged into 1 CBCT image, and the crestal (S1), midroot (S2), and apical (S3) level reference lines will be marked and saved in jpeg format 

To measure the position changes in the labial and palatal root and alveolar bone in the CBCT images, each tooth will be measured at S1, S2, and S3 levels from the cementoenamel junction every 3mm along the axis of the incisor. The following measurements will be obtained (1) alveolar BR, which is the horizontal distance between labial or palatal alveolar bone on T0 and T1 scans; (2) TM, defined as the horizontal distance the labial or palatal borders of the incisor root on T0 and T1 scans; (3) the BT ratio, defined as BR divided by TM; and (4) incisor movement pattern (IMP) representing the retraction type of incisors, which is defined as TM(S3)/ TM (S1).demonstrate the features of palatal BR more clearly, all patients will be classified according to whether the root penetrated the original cortical bone border and whether BR will be detected.


 
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