| CTRI Number |
CTRI/2026/01/102335 [Registered on: 28/01/2026] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized controlled trial comparing Pendulum appliance and the miniscrew-anchored cantilever system for molar distalization |
|
Scientific Title of Study
|
To evaluate and compare the dentoalveolar, skeletal and soft tissue changes in molar distalization between pendulum appliance and the miniscrew-anchored cantilever system:A randomized 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 |
DR SHANEEL SHAILESH KAMAT |
| Designation |
Post Graduate Student |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Himachal Dental College and Hospital,Sundernagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175002
India |
| Phone |
9604033104 |
| Fax |
|
| Email |
shaneelkamat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEK MAHAJAN |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics, Himachal Dental College and Hospital, Sundernagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175002
India |
| Phone |
9736222587 |
| Fax |
|
| Email |
mahajanortho@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR VIVEK MAHAJAN |
| Designation |
Professor |
| Affiliation |
Himachal Dental College and Hospital |
| Address |
Department of Orthodontics and Dentofacial Orthopaedics,Himachal Dental College and Hospital, Sundernagar, Mandi, Himachal Pradesh
Mandi
HIMACHAL PRADESH
175002
India |
| Phone |
9736222587 |
| Fax |
|
| Email |
mahajanortho@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
HIMACHAL DENTAL COLLEGE AND HOSPITAL |
| Address |
Himachal Dental College and Hospital, Sundernagar, Mandi, Himachal Pradesh |
| Type of Sponsor |
Other [PRIVATE DENTAL COLLEGE] |
|
|
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 VIVEK MAHAJAN |
Himachal Dental College and Hospital |
Department of Orthodontics and Dentofacial Orthopaedics,Himachal Dental College and Hospital, Himachal Dental College and Hospital , Sundernagar, Mandi, Himachal Pradesh, 175002
Mandi
HIMACHAL PRADESH |
9736222587
mahajanortho@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMMITTEE OF HIMACHAL DENTAL COLLEGE AND HOSPITAL, SUNDERNAGAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
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 |
| Intervention |
MINISCREW-ANCHORED CANTILEVER SYSTEM |
Buccal and palatal miniscrews will be placed bilaterally between the maxillary first molar and second premolar. A cantilever system will be fabricated and attached to the molar band. Distalizing force will be applied from the miniscrew to the cantilever hook with periodic reactivation until desired molar distalization has been achieved
Total duration to achieve desired results per patient will be approximately 5 to 6 months |
| Comparator Agent |
PENDULUM APPLIANCE |
Conventional pendulum appliance fabricated according to Hilgers guidelines will be cemented on maxillary first premolars, second premolars and first molars. Periodic activation will be done until desired molar distalization is achieved.
Total duration to achieve desired results per patient will be approximately 5 to 6 months |
|
|
Inclusion Criteria
|
| Age From |
11.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Angles Class II molar relationship
Skeletal Class I relationship
Horizontal and average growth pattern
Orthognathic facial profile
No history of previous orthodontic treatment
Detailed medical and dental history to be taken to rule out any systemic disease
|
|
| ExclusionCriteria |
| Details |
Patients with trauma or craniofacial anomalies
Congenitally missing or impacted teeth in the anterior segment
Subjects with severe anterior discrepancies where extraction is obligatory
Patients having vertical growth pattern
Cleft lip and palate patients
Patients with skeletal Class II and Class III malocclusion.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate and compare the dentoalveolar, skeletal and soft tissue changes in molar distalization between pendulum appliance and the miniscrew anchored cantilever system |
data recorded at Baseline and
thereafter every month until desired results will be achieved, approximately per patient around 5 to 6 months will be required for completion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/07/2026 |
| 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="7"
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
|
This randomized controlled clinical trial aims to evaluate and compare the dentoalveolar, skeletal, and soft tissue changes produced during maxillary molar distalization between a conventional pendulum appliance and a miniscrew-anchored cantilever system in patients with Class II malocclusion. A total sample size of 40 participants will be included and randomly allocated into two groups, with 20 subjects in each group. Standardized lateral cephalograms will be obtained before (T1) and after (T2) molar distalization to assess skeletal, dental, and soft tissue changes. The findings of this study will help determine the relative effectiveness and anchorage control of the two distalization techniques in the management of Class II malocclusion. |