| CTRI Number |
CTRI/2023/06/054431 [Registered on: 26/06/2023] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparative Evaluation Of Clinical And Radiological Outcome Of Teeth Coloured Crowns And Steel Crowns In Primary Mandibular Molars: A Randomised Control Study |
|
Scientific Title of Study
|
Comparative Evaluation Of Clinical Outcome Of Stainless Steel Crown And Kedo Zirconia Crowns In Primary Mandibular Molars |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Guru Vishnu |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College |
| Address |
Department Of Preventive And Paediatrics, 5th Floor, Clinic-25,
Saveetha Dental College,
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
641659
India |
| Phone |
|
| Fax |
|
| Email |
vishnu.guru10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College |
| Address |
Department Of Preventive and Paediatrics, Clinic-28, 5th Floor,
Saveetha Dental College,
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
|
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Guru Vishnu |
| Designation |
Post Graduate |
| Affiliation |
Saveetha Dental College |
| Address |
Clinic-28(Department Of Pedodontics), 5th Floor, Saveetha Dental College,162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU
600077
India |
| Phone |
988429386 |
| Fax |
|
| Email |
vishnu.guru10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College,
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College |
| Address |
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077 |
| Type of Sponsor |
Private medical 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 |
| Guru Vishnu |
Saveetha Dental College |
Department Of Pedodontics,
Clinic-28,
5th Floor,
Saveetha Dental College,
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu 600077
Chennai
TAMIL NADU |
9965534186
vishnu.guru10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K02||Dental caries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Kedo Zirconia Crown |
It is a tooth coloured prefabricated crown used for primary tooth. It is made up of Zirconia. |
| Comparator Agent |
Stainless Steel Crown |
For many years the teeth were restored using silver colour crowns and now new teeth coloured crowns made up of zirconia that is aesthetic was found. So we are comparing both the crowns clinically |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
-Healthy Children within age group 4-8 years
-Children with atleast one decay in the mandibular molars requiring restoration.
-Co-operative patient with a behavioural rating of “positive†or “definitively positive†according to Frankl Behavior Classification Scale
-Opposing Tooth Present
|
|
| ExclusionCriteria |
| Details |
-Children with systemic diseases and special needs
-Patient with allergy or hypersensitivity to nickel
-Teeth with proximity to exfoliation and resorption of the root passed its half
-Children who suffer from bruxism
-Presence of wear on the opposing tooth or absence of opposing tooth
-Children with severe malocclusion, traumatic dental injury and developmental anomalies of the tooth
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical & radiological outcomes of kedo zirconia crowns & stainless steel crowns |
It will be assessed at Baseline, 1 month, 3 months, 6 months, 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Clinical Outcome:
-Marginal Adaptation
-Crown Fit Assessment
-Secondary Caries
-Gingival Health
-Proximal Contact
-Colour
-Retention
Radiological Outcome:
-Interproximal Bone Level
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/06/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
"none yet" |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To evaluate and compare the clinical and radiographic success of zirconia crowns and stainless steel crowns in primary mandibular molars. |