| CTRI Number |
CTRI/2026/01/101181 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Determining the Optimal Fit of Zirconia Crowns in the South Indian Population
|
|
Scientific Title of Study
|
Do One-Size Crowns Fit All? A Comparative Study of Zirconia Crown Fit and Tooth Morphology in South Indian Children |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
A Hannah Harshavardhani |
| Designation |
Intern |
| Affiliation |
Sathyabama Dental College and Hospital |
| Address |
Room:4, 1st floor,Sathyabama Dental college and Hospital.
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600119
India |
| Phone |
9176048166 |
| Fax |
|
| Email |
hannahraj1781@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
A Hannah Harshavardhani |
| Designation |
Intern |
| Affiliation |
Sathyabama Dental College and Hospital |
| Address |
Room:4, 1st floor,Sathyabama Dental college and Hospital.
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600119
India |
| Phone |
9176048166 |
| Fax |
|
| Email |
hannahraj1781@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
A Hannah Harshavardhani |
| Designation |
Intern |
| Affiliation |
Sathyabama Dental College and Hospital |
| Address |
Room:4, 1st floor,Sathyabama Dental college and Hospital.
Jeppiaar Nagar, SH 49A, Chennai, Tamil Nadu
Chennai
TAMIL NADU
600119
India |
| Phone |
9176048166 |
| Fax |
|
| Email |
hannahraj1781@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sathyabama Dental College amd Hospital, Department of Pedodontics, 1st floor, Room: 3,Jeppiaar Nagar, Rajiv Gandhi Salai, Semmancheri, Chennai - 600 119, Tamilnadu, INDIA |
|
|
Primary Sponsor
|
| Name |
A Hannah Harshavardhani |
| Address |
Room: 4, 1st floor,Department of Pediatric and Preventive Dentistry, Sathyabama Dental college and Hospital, Chennai 600118. |
| Type of Sponsor |
Other [Sathyabama Dental College and Hospital, Chennai] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Santhosh Priya |
Room:4, 1st floor, Department of Pediatric and Preventive Dentistry, Sathyabama Dental College and Hospital. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santhosh Priya AKR |
Sathyabama Dental College and Hospital. |
Department of Pediatric and preventive dentistry, 1st floor, Room: 4
Chennai
TAMIL NADU |
9566525775
santhosh.appiya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
screening intervention with tooth with ICDAS score 0to2 |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Measurement of mesiodistal amd buccolingual width of primary first molars |
Bucco lingual and Mesio distal width of primary 1st molars will be measured using meshmixer software after scanning maxillary and mandibular first primary molars
Measure is taken only once |
| Comparator Agent |
NU smile zirconia crowns |
Bucco lingual and Mesio distal width of Nu smile zirconia crowns of variois sizes will be compared with the measured mesiodistal and buccolingual width of first primary molars and closest crown for the study population will be determined |
| Comparator Agent |
Propedo crowns |
Bucco lingual and Mesio distal width of Propedo zirconia crowns of various sizes will be compared with the measured mesiodistal and buccolingual width of first primary molars and closest crown for the study population will be determined |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Frankl’s behaviour scale III and IV.
first prmary molars with ICDAS score 0-2.
|
|
| ExclusionCriteria |
| Details |
Children diagnosed with medical conditions limiting their cognitive development.
Patient without parental consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean BL and Md dimensions of primary first molars in south Indian population |
No time points - cross-sectional study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/02/2026 |
| 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="6"
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 study assessed whether commonly available zirconia crowns match the natural tooth dimensions of South Indian children. By digitally measuring the mesiodistal and buccolingual dimensions of primary first molars in 100 children, the results showed that Propedo zirconia crowns more closely matched the tooth morphology than Nu Smile crowns. While no sex differences were found in mesiodistal dimensions, females showed slightly higher buccolingual values for tooth 64. Overall, Propedo crowns provided a better anatomical fit, suggesting they may reduce tooth preparation and improve clinical efficiency |