| CTRI Number |
CTRI/2025/04/084860 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Shape OF PALATE Affects Molar Angle in People with Different Facial Types – A 3D X-Ray Study |
|
Scientific Title of Study
|
Association of palatal depth on molar inclination in Hyperdivergent,Hypodivergent and Normodivergent subjects- A CBCT study |
| 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 Bhakti Kalbande |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
110, Dept. of Orthodontic and Dentofacial Orthopedics, Ranjeet Deshmukh Dental College, Digdoh hills, Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7972150022 |
| Fax |
|
| Email |
kalbandebhakti17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Shenoy |
| Designation |
Post Graduate Student |
| Affiliation |
Professor & HOD |
| Address |
room no 110,Ranjeet Deshmukh Dental College and Research Centre
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822573393 |
| Fax |
|
| Email |
dr_usha_shenoy@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhakti Kalbande |
| Designation |
Post Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
11, Collector Colony Camp Amravati 444-602
Amravati
MAHARASHTRA
444602
India |
| Phone |
7972150022 |
| Fax |
|
| Email |
kalbandebhakti17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Nagpur, India, 440019 |
|
|
Primary Sponsor
|
| Name |
Dr Bhakti Kalbande |
| Address |
110, Dept. of Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills,440019 Nagpur, Maharashtra, India |
| Type of Sponsor |
Other [Dr. Bhakti Kalbande] |
|
|
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 Bhakti Kalbande |
Ranjeet Deshmukh Dental College and Research Centre |
room no 110, department of Orthodontic and Dentofacial Orthopedics Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills, Nagpur
Nagpur
MAHARASHTRA |
7972150022
kalbanebhakti17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VSPM RDDC NAGPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Hyperdivergent, Hypodivergent and Normodivergent subjects |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of both sexes of age group between 18-30
2.patients who are advised CBCT for the purpose of Orthodontic diagnosis and treatment planning. |
|
| ExclusionCriteria |
| Details |
1. Subjects with history of orthodontic treatment
2. Presence of any kind of congenital abnormality for eg.cleft lip and palate
3.Restoration/cariopus/missing maxillary first molar |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
• To assess the palatal vault depth in 3 skeletal pattern of hyperdivergent, Hypodivergent and Normodivergent subjects.
• To assess the inclination (buccal, lingual, or upright) of the maxillary molars in relation to palatal depth
• To compare the association of palatal depth with molar inclination across the 3 skeletal patterns of hyperdivergent, Hypodivergent and Normodivergent subjects
• To analyze how the molar inclination is affected by palatal depth.
|
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
30/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/05/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
|
The study titled "Association of Palatal Depth with Molar Inclination in Hyperdivergent, Hypodivergent, and Normodivergent Subjects: A CBCT Study" aims to explore the correlation between palatal depth and molar inclination across different craniofacial skeletal patterns using Cone Beam Computed Tomography (CBCT). Introduction: Facial aesthetics and dental occlusion are influenced by craniofacial morphology, particularly palatal depth and molar inclination. Palatal depth is categorized using Korkhous’ Palatal Index (1939) as high (>22 mm), moderate (19–22 mm), or shallow (<19 mm). Traditional methods fail to account for molar inclination, which can impact orthodontic diagnosis. CBCT provides precise 3D imaging, enabling a detailed understanding of the relationship between palatal depth and molar inclination. Research Objectives: - To assess palatal vault depth in hyperdivergent, hypodivergent, and normodivergent skeletal patterns.
- To evaluate maxillary molar inclination (buccal, lingual, or upright) in relation to palatal depth.
- To analyze how palatal depth affects molar inclination.
Research Methodology: - Study Type: Cross-sectional, analytical study.
- Study Setting: Conducted at Ranjeet Deshmukh Dental College and Research Centre.
- Sample Size: 75 subjects (25 per skeletal pattern group).
- Inclusion Criteria: Patients (18–30 years) undergoing CBCT for orthodontic treatment.
- Exclusion Criteria: Previous orthodontic treatment, congenital abnormalities, syndromes, missing/restored maxillary first molar.
- Data Analysis: Statistical tests (One-way ANOVA, Pearson’s chi-square test) using STATA software.
Significance & Research Gap: Past studies have explored craniofacial morphology and molar inclination, but limited research compares all three skeletal patterns using standardized CBCT techniques. This study aims to fill that gap. Expected Outcome: A clearer understanding of how palatal depth influences molar inclination, aiding in improved orthodontic treatment planning, particularly for cases requiring arch expansion. Study Timeline: 18 months (9 months data collection, 6 months analysis, 3 months conclusion). |