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CTRI Number  CTRI/2026/03/105141 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 28/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the correctness of position of fixed braces placed under direct vision or using magnifying device. 
Scientific Title of Study   Comparison of the accuracy and reliability of bracket positioning during direct bonding in fixed orthodontic cases, with and without the use of magnification loupes: A split-mouth randomised controlled 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  Teresa Xavier 
Designation  Postgraduate Junior Resident 
Affiliation  Jawaharlal Institute Of Postgraduate Medical Education And Research 
Address  Division of Orthodontics and Dentofacial Orthopaedics, Department of Dentistry, Jawaharlal Institute Of Postgraduate Medical Education And Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9495817573  
Fax    
Email  tresxavier@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Madhan B 
Designation  Professor(Senior Scale) 
Affiliation  Jawaharlal Institute Of Postgraduate Medical Education And Research 
Address  Division of Orthodontics and Dentofacial Orthopaedics, Department of Dentistry, Jawaharlal Institute Of Postgraduate Medical Education And Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9498066130  
Fax    
Email  madhanb@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Madhan B 
Designation  Professor(Senior Scale) 
Affiliation  Jawaharlal Institute Of Postgraduate Medical Education And Research 
Address  Division of Orthodontics and Dentofacial Orthopaedics, Department of Dentistry, Jawaharlal Institute Of Postgraduate Medical Education And Research, Puducherry

Pondicherry
PONDICHERRY
605006
India 
Phone  9498066130  
Fax    
Email  madhanb@hotmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 
 
Primary Sponsor  
Name  Teresa Xavier 
Address  Division of Orthodontics and Dentofacial Orthopedics, Department of Dentistry,Jawaharlal Institute Of Postgraduate Medical Education And Research Puducherry- 605006 
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 
Teresa Xavier  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry  Department of Dentistry, First Floor-Screening OPD, Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Dhanvantari Nagar, Gorimedu, Puducherry-605006
Pondicherry
PONDICHERRY 
9495817573

tresxavier@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee( Human Studies) for Interventional Studies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bonding of orthodontic brackets on teeth under direct vision  The orthodontic brackets will be bonded to the teeth on the comparator side under direct vision 
Intervention  Bonding of orthodontic brackets on teeth under magnification  The orthodontic brackets will be bonded to the teeth on the experimental side under 2.5X magnification from a spectacle-mounted dental loupe 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects planned for fixed orthodontic treatment at the Postgraduate Orthodontic Clinic of the Department of Dentistry, JIPMER 
 
ExclusionCriteria 
Details  Patients with:
1 Anterior crowding exceeding 6mm
2 Previous orthodontic treatment
3 Grossly carious, fractured, or restored teeth in the
incisor to first molar region.
4 Teeth with generalised hypoplasia, fluorosis,
attrition, or abnormal crown morphology.
5 Partially erupted and missing teeth in the incisor
to first molar region.
6 Mouth opening < 45 mm
7 Symptomatic TMD
8 Craniofacial and developmental anomalies. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Accuracy of bracket position.
2. Reliability
of bracket positioning during direct bonding of conventional stainless steel PEA brackets, with and without magnification loupes,using digital analysis of intraoral 3D models in orthodontic model software. 
T0 : Baseline.
T1 : Within 7 days of T0
T2 : 4 weeks after T1 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the procedural time for bracket positioning during direct bonding of conventional stainless steel PEA brackets with and without magnification loupes  T0: Baseline
T1: Within 7 days of T0
T2: 4 weeks after T1 
 
Target Sample Size   Total Sample Size="23"
Sample Size from India="23" 
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)   01/05/2026 
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="2"
Months="0"
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  

Background:Accurate and consistent bonding of orthodontic brackets is incumbent on the clear visualisation of the tooth morphology and its relationship with the adjacent teeth. Using magnification loupes is a potentially beneficial manoeuvre that is gaining increased clinical adoption in dental procedures. However, its usefulness in improving the outcome of direct orthodontic bonding has not been investigated adequately. The present investigation is designed to objectively determine whether the use of dental loupes confers any measurable advantage in the accuracy and reliability of bracket placement compared to direct vision.

Participants: 23 individuals planned for fixed appliance treatment in the Orthodontic clinic of the Department of Dentistry, JIPMER, Puducherry.

Procedure: At baseline (T0), a full-arch intraoral digital scan will be obtained to plan the ideal bracket positions. The patient will be scheduled for the first bonding (T1 ) within 7 days of the T0 scan. The SNOSE covers will be opened to reveal the side and order allocation for the participant. All the teeth planned for bonding ( first molar to first molar in both arches) will be cleaned and polished with non-fluoridated prophylaxis paste. The surface will be rinsed with an air-water syringe for 10 seconds and dried with oil-free compressed air. The bonding process will start on the left or right maxillary quadrant, depending on the bonding order ( with or without loops) revealed by the random sequence. This will be followed by the mandibular arch on the same side, and then by the maxillary and mandibular quadrants of the other side in the same sequence. Within each quadrant, the bonding will start from the central incisor and finish with the first molar, followed immediately by the intraoral scan of the quadrant. To avoid enamel damage from subsequent debonding, all the brackets at T1 will be bonded without etching and without curing the light-cured orthodontic adhesive. At T2 ( minimum of 4 weeks after T1), the actual bonding of orthodontic brackets and the third intraoral scans will be performed. The procedure will be the same as in T1, except that the bonding process will now involve etching and curing the adhesive as in standard bonding protocol. 

 

Primary outcomes:

1.  Bracket Position Accuracy: the difference between bracket positions in T2 and T0, estimated using linear (differences in the x and y axes in mm) and angular ( differences in slot angulation in degrees) variables.

2.  Reliability of Bracket Positioning: the difference between bracket positions in T2 and T1, estimated using linear (differences in the x and y axes in mm) and angular ( differences in slot angulation in degrees) variables.

Secondary outcome:

3.   Time taken for bracket positioning – estimated as the time elapsed in seconds from the start of bracket positioning in the central incisor till the completion of bonding in each quadrant.

Outcome assessment will be done by the same investigator, blinded to the study groups. 

Statistical analysis: The bracket positioning errors will be summarised with mean ± SD or median and IQR. Intergroup comparisons will be done using the Paired T test / Wilcoxon signed rank test. Subgroup analysis for all the outcome variables will be done based on the side of bonding (Right vs Left), Arch (Upper vs Lower) and teeth class (Anterior vs Posterior). Reliability will be calculated using the Intraclass Correlation Coefficient (ICC) and Bland-Altman plots. The reliability of the assessment method will be estimated using ICC.

Clinical Implications: The results of the study will help make recommendations for the routine use of magnification loupes during direct bonding of orthodontic brackets.


 
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