| 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. |
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee( Human Studies) for Interventional Studies |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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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. |
|
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Outcome Assessor Blinded |
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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 |
|
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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 |
|
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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 |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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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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