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CTRI Number  CTRI/2021/03/032010 [Registered on: 15/03/2021] Trial Registered Prospectively
Last Modified On: 22/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Radiation Therapy
Dentistry 
Study Design  Other 
Public Title of Study   Checking the reliability of photograph and cephalogram method in orthodontic patients for treatment planning 
Scientific Title of Study   Evaluation of reliability of profile photographs for treatment planning, compared to cephalometric evaluation in orthodontic patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR DHRUVI DHARMENDRAKUMAR PANDYA 
Designation  PG STUDENT 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE 
Address  MANUBHAI PATEL DENTAL COLLEGE VISHWAJYOTI ASHRAM NEAR VISHWAMITRI BRIDGE OPP GUJARAT MAHINDRA TRACTOR VADODARA GUJARAT 390011 INDIA
MANUBHAI PATEL DENTAL COLLEGE VISHWAJYOTI ASHRAM NEAR VISHWAMITRI BRIDGE OPP GUJARAT MAHINDRA TRACTOR VADODARA
Vadodara
GUJARAT
390011
India 
Phone  8200875528  
Fax    
Email  dhruvipandya4@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NIKUNJ PATEL 
Designation  READER 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE 
Address  DEPARTMENT OF ORTHODONTICS MANUBHAI PATEL DENTAL COLLEGE VISHWAJYOTI ASHRAM BRIDGE OPP GUJARAT MAHINDRA TRACTOR VADODARA GUJARAT 390011 INDIA

Vadodara
GUJARAT
390011
India 
Phone  8128460652  
Fax    
Email  nikunj_84@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DRDHRUVI PANDYA 
Designation  PG STUDENT 
Affiliation  MANUBHAI PATEL DENTAL COLLEGE 
Address  15,PUNIT SOCIETY NEAR NEW CIVIL HOSPITAL BHARUCH-392001

Bharuch
GUJARAT
392001
India 
Phone  8200875528  
Fax    
Email  dhruvipandya4@gmail.com  
 
Source of Monetary or Material Support  
DEPARTMENT OF ORTHODONTICS MANUBHAI PATEL DENTAL COLLEGE VADODARA 
 
Primary Sponsor  
Name  DR DHRUVI PANDYA 
Address  MANUBHAI PATEL DENTAL COLLEGE,VISHWAJYOTI ASHRAM NEAR VISHWAMITRI BRIDGE OPP. GUJARAT MAHINDRA TRACTOR VADODARA390011 
Type of Sponsor  Other [] 
 
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 
Dhruvi pandya  DEPARTMENT OF ORTHODONTICS AND DENTOFACIAL ORTHOPAEDICS,NANUBHAI PATEL DENTAL COLLEGE AND HOSPITAL  Manubhai patel dental collegevishwajyoti Ashram Near Vishwamitri Bridge Opp. Gujarat Mahindra Tractor Vadodara 390011Vadodara GUJARAT
Vadodara
GUJARAT 		 8200875528

dhruvipandya4@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHARAJA KRISHNAKUMAR SINHJI BHAVNAGAR UNIVERSITY ETHICS COMMITTEE FOR MDS COURSE AND DENTAL RESEARCH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  cephalometric records  Cephalometric radiographs will be taken in an NHP (Natural head position) with maximum intercuspation and lips at rest. A chain with a 200 g weight will be hung at its end will be suspended in front of the patient, in the midsagittal plane, to register the VER (Vertical reference line). While achieving an NHP (Natural head position), a modified protractor will be placed on the tip of the nose and the soft-tissue pogonion to check if the same position will be achieved during photographic record 
Intervention  photographic records  Standardized right profile photographs will be taken in the natural head position (NHP), with maximum intercuspation and lips at rest. Glasses will be removed and hair will be piled high on the head to ensure that the patient’s forehead, neck, and ears will clearly visible. Adhesive dots will be placed on anatomic landmarks obtained by palpation.  
 
Inclusion Criteria  
Age From  9.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Patients who come for fixed orthodontic treatment.
Patients who give consent for the proposed study
Patients who are systemically healthy
 
 
ExclusionCriteria 
Details  Patients having craniofacial or Dentofacial Syndromes.
Patients having neurologic disturbances.
Non-compliant patients. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Alternation 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
compare and evaluate cephalometric and photographic measurements in patients requiring orthodontic treatment  not applicable  
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="262"
Sample Size from India="262" 
Final Enrollment numbers achieved (Total)= "265"
Final Enrollment numbers achieved (India)="265" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/04/2021 
Date of Study Completion (India) 22/11/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

262 subjects will be included in this study.

 

1. Cephalometric measurements of orthodontically untreated patients

 

2. Photographic measurements of  orthodontically untreated patient

 

Patients who come for fixed orthodontic treatment  in Department Of Orthodontics, Manubhai Patel Dental College, Hospital & O.R.I., Vadodara  will be considered for this study. Lateral cephalograms and standardized profile photographs  will  be obtained  from 262 subjects of  orthodontically untreated patients. Parents or legal guardians will be  previously informed about the procedures and given  their written agreement to the investigation.

 

PHOTOGRAPHIC PROCEDURE:

 Standardized right profile photographs will be  taken in the natural head position (NHP), with maximum intercuspation and lips at rest. Glasses will be  removed and hair will be  piled high on the head to ensure that the patient’s forehead, neck, and ears will clearly visible. Adhesive dots will be placed on anatomic landmarks obtained by palpation.

 Anatomic landmarks:

1.N’ indicates soft tissue nasion;

2.Tr’ indicates tragion;

3.Or’, soft tissue orbitale;

4.A’, soft tissue subspinale;

5.B’, soft tissue supramentale;

6.Go’, soft tissue gonion;

7.Pog’, soft tissue pogonion;

8.Me’, soft tissue menton;

9.Sn’, subnasale.

          The Me’ point will be marked with an

adhesive styrofoam bead to allow better visibility by the camera.

            To obtain an NHP(Natural head position), a 75× 30 cm mirror will be  hung on a tripod, which allow vertical adjustments according to the subject’s height. Patients will be  asked to keep feet slightly apart and arms relaxed and to stand a step behind a line drawn 120 cm from the mirror. To achieve the ‘‘orthoposition,’’ patients will be  instructed to tilt their head up and down with decreasing amplitude until they felt relaxed, take  a step forward, and keep looking straight ahead   into the reflection of their eyes in the mirror. A protractor will be  placed on the tip of the nose and the soft tissue pogonion.

 

·         The same digital camera  with the same lens and flash  will be  used for all photographic records. It will be  secured on a tripod for stabilization and will be adjusted according to the subject’s height.

 

 CEPHALOMETRIC PROCEDURE:

 

 Cephalometric radiographs will be taken in an  NHP (Natural head position)  with maximum intercuspation and lips at rest.  A chain with a 200 g weight will be  hung at its end will be suspended in front of the patient, in the midsagittal plane, to register the  VER (Vertical reference line).  While achieving an NHP (Natural head position), a modified protractor will be  placed on the tip of the nose and the soft-tissue pogonion to check if the same position  will be achieved during photographic record.

 

 All lateral cephalograms will be traced from the standardized SORDEX machine (PONOD+ model) with distance of 5 feet from object to film will be exposed with 72Kvp,10mA, and  14 seconds of exposure time with help of Digora software.

 
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