| CTRI Number |
CTRI/2026/03/106282 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
16/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing the movement of one vs two upper back teeth using transparent trays |
|
Scientific Title of Study
|
Comparison of efficacy of single molar vs two molar distalization in maxillary arch using V-pattern staging with clear aligner therapy: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 |
ABDUL RAHMAAN A |
| Designation |
PG STUDENT |
| Affiliation |
SCB Dental college and hospital Cuttack Odisha |
| Address |
Department of Orthodontics and Dentofacial orthopedics
SCB Dental college and hospital cuttack odisha
Cuttack ORISSA 753007 India |
| Phone |
9941122330 |
| Fax |
|
| Email |
dr.abdulrahmaanortho@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Surya kanta das |
| Designation |
Professor and HOD |
| Affiliation |
SCB Dental college and hospital, Cuttack, Odisha |
| Address |
Department of Orthodontics and Dentofacial orthopedics
SCB Dental college and hospital,cuttack,odisha
Cuttack ORISSA 753007 India |
| Phone |
9861099237 |
| Fax |
|
| Email |
orthosuryakantadas@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr ABDUL RAHMAAN |
| Designation |
PG STUDENT |
| Affiliation |
|
| Address |
Department of Orthodontics and Dentofacial orthopedics
SCB Dental college and hospital cuttack odisha
Cuttack ORISSA 753007 India |
| Phone |
9941122330 |
| Fax |
|
| Email |
dr.abdulrahmaanortho@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
ABDUL RAHMAAN A |
| Address |
Department of Orthodontics and Dentofacial orthopedics SCB Dental college and hospital,cuttack,odisha
Cuttack
ORISSA
753007
India |
| Type of Sponsor |
Other [Self sponsor] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR SURYA KANTA DAS |
SCB Dental college and hospital cuttack |
SCB Dental college and hospital cuttack Cuttack ORISSA |
9861099237
orthosuryakantadas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE SCB DENTAL COLLEGE AND HOSPITAL CUTTACK ODISHA |
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: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP1- SINGLE MOLAR DISTALIZATION WITH ALIGNERS
|
1. To assess the treatment effects (amount of distalization, distal tipping, and vertical movement) of maxillary molars sequential distalization with clear aligner therapy. |
| Comparator Agent |
GROUP2- TWO MOLAR DISTALIZATION WITH ALIGNERS |
1. To assess the treatment effects (amount of distalization, distal tipping, and vertical movement) of maxillary molars sequential distalization with clear aligner therapy. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with a bilateral class II molar or end to-end relationship.
2.Patients with age group :18-25.
3.Subjects with good compliance during the treatment (wearing aligner time, more than 20 hours per day).
4.Patients with good control of oral hygiene and periodontal health.
|
|
| ExclusionCriteria |
| Details |
1.Patients with transverse dental or skeletal discrepancies.
2.Patients with vertical skeletal discrepancies.
3 Signs and/or symptoms of temporomandibular disorders.
4.Patients with periodontal disease.
5.Patients with prosthodontics rehabilitations of the maxillary molars.
6.Patients with systemic disease, syndromes and cleft lip and palate.
7.Subjects with prior orthodontic treatment.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
To assess the treatment effects amount of distalization distal tipping and vertical movement of maxillary molars sequential distalization with clear aligner therapy
|
To assess the treatment effects before and after 8 months of molar distalization with clear aligner therapy
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the predicted tooth movement with the achieved tooth movement in maxillary molar distalization with clear aligner therapy |
To compare the predicted tooth movement with the achieved tooth movement in maxillary before & after 8 months of molar distalization with clear aligner therapy |
|
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Target Sample Size
|
Total Sample Size="24" Sample Size from India="24"
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)
|
01/04/2026 |
| 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="0" Months="8" 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
|
Clear Aligner Therapy CAT is a method used to straighten teeth using clear custom made plastic aligners that apply light pressure to gradually move teeth into the desired position. Compared with fixed orthodontic appliances clear aligners are more comfortable and aesthetically acceptable which has increased their popularity. The treatment is based on computer aided design where a three dimensional digital model of the dental arches is created and tooth movements are planned using specialized software. Initially clear aligners were used mainly for simple malocclusion cases such as mild crowding or small space closure but their application has expanded to treat more complex cases including extraction cases open bites and Class II malocclusions. Maxillary molar distalization is a common non extraction method used to correct Class II molar relationships particularly in patients with mild skeletal discrepancies or maxillary dentoalveolar protrusion. Traditionally molar distalization was achieved using extraoral appliances such as headgear which require high patient compliance. To reduce dependence on compliance several intraoral appliances and skeletal anchorage methods have been introduced. However these methods may produce unwanted effects such as reduction in facial height clockwise rotation of the mandible premolar extrusion molar tipping and loss of anterior anchorage. Clear aligners can also achieve Class II correction through sequential maxillary molar distalization with good predictability when attachments are placed on the teeth. V- staging patterns are used for distalization with clear aligners sequential distalization and simultaneous distalization. Sequential distalization is considered more effective and is commonly used in clinical practice. In this approach the second molars are distalized first followed by the first molars once the second molars have moved halfway and then the premolars move sequentially. The effectiveness of this movement is influenced by staging strategy and the design position and shape of attachments. There is limited clinical evidence comparing the effectiveness of different staging approaches in maxillary molar distalization with clear aligners. Therefore the purpose of this study is to compare the efficacy of V- staging patterns for maxillary molar distalization in two study groups using clear aligner therapy. In this study patients were instructed to change aligners every week and wear them for twenty two hours per day while maintaining a daily compliance log to record the duration of aligner wear. Digital intraoral scans were obtained for each participant and digital dental models were generated. These models were used to plan treatment and fabricate thermoplastic clear aligners using a pressure molding machine. Attachments were bonded to the teeth to facilitate the required tooth movements. For each patient three digital models of the maxillary arch were collected including pre treatment model T0 virtual treatment plan model T1 and post treatment model at the end of distalization phase T2. These models were used to assess the predicted and achieved tooth movements. The digital models were imported into software to perform superimposition and measurements. Initially T0 and T1 were compared to determine the prescribed movement. The buccal cusp tips of the first and second molars were used as landmarks to measure distalization. T0 and T2 were then compared to evaluate the achieved movement after treatment. The distal movement of the mesiobuccal cusp and distobuccal cusp of each molar was analyzed. Prescription referred to the amount of movement planned between T0 and T1 while achieved movement referred to the movement observed between T0 and T2. Accuracy was calculated as the percentage of achieved movement compared with the planned movement. A reference coordinate system was established to describe tooth movement in three spatial dimensions and to allow comparison between predicted and achieved tooth movements. |