| CTRI Number |
CTRI/2024/06/069622 [Registered on: 27/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
"Comparing Zirconia Endocrowns and stainless steel crowns for children Teeth: A clinical study" |
|
Scientific Title of Study
|
Comparison of CAD CAM milled Zirconia crown versus stainless-steel crowns in primary teeth |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAILANATHAN |
| Designation |
Postgraduate |
| Affiliation |
Adhiparasakthi Dental College and Hospital |
| Address |
Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9626311997 |
| Fax |
|
| Email |
2223217@apdch.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Vasanthakumari |
| Designation |
Professor and Head |
| Affiliation |
|
| Address |
Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9443615196 |
| Fax |
|
| Email |
vkpedo@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAILANATHAN |
| Designation |
Postgraduate |
| Affiliation |
|
| Address |
Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur
Kancheepuram
TAMIL NADU
603319
India |
| Phone |
9626311997 |
| Fax |
|
| Email |
2223217@apdch.edu.in |
|
|
Source of Monetary or Material Support
|
| Dental OPD in Adhiparasakthi Dental College and hospital and dental camps Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shailanathan |
Adhiparasakthi Dental College and Hospital |
Room No 6, Department of Pediatric and Preventive Dentistry,
Adhiparasakthi Dental College and Hospital, Melmaruvathur
Kancheepuram
TAMIL NADU |
9626311997
2223217@apdch.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board- Adhiparasakthi Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K085||Unsatisfactory restoration of tooth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD CAM milled Zirconia endocrowns |
For Zirconia endocrowns, after pulp therapy, occlusal clearance will be achieved by making 1.5 mm deep cuts using a round-end tapered stone. Axial depth cuts will be done for the occlusal reduction using a wheel stone and a cervical sidewalk or "butt joint" finish line will be prepared. Axial preparation will be completed to eliminate the proximal wall undercut. The pulp chamber walls will be flared to a standard degree of divergence with an 8° tapered stone. The internal angles of the margins will be smoothed and rounded using the same diamond tip. The internal angles will then be polished with an abrasive rubber tip, giving a polished and smoothed preparation. The tooth is then scanned using intraoral scanner and crown will be designed using exocad software and milled using densply printer. The finished endcrown will be luted with RMGIC cement.
|
| Comparator Agent |
Stainless steel crowns |
For stainless steel crowns, the reduction of the occlusal surface by 1.0 to 1.5 mm will be done using a pear-shaped bur to produce uniform occlusal reduction. Interproximal slicing mesially and distally will be done using a tapered diamond bur. The reduction will be done in a manner that allows a probe to pass through the contact area. Interocclusal clearance will be checked using a wax sheet (1.5-2 mm). The selected crown will not be more than 1 mm subgingivally, and if there is excessive shrinking of the gingival tissues, then the segment of the crown will be decreased. After reduction with a white stone bur, the margins of the crowns will be smoothened using a rubber disk bur. Then the crown will be luted using type 1 GIC. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Cooperative child
Patient visiting for pulp therapy
Patients willing to take part in study
Patients with sound health
Presence of unilateral and bilateral deep carious lesion of primary molars requiring pulpal therapy with at least two- third of the root length
|
|
| ExclusionCriteria |
| Details |
Patients with preshedding mobility
Patients with parafunctional habits
Non restorable tooth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The clinical performance of CAD CAM milled Zirconia endocrowns and stainless steel crowns |
at the intervals of 1, 3 and 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The gingival health in the patients with CAD- CAM milled Zirconia endocrowns & stainless steel crowns |
at the intervals of 1, 3 & 6 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2024 |
| Date of Study Completion (India) |
17/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Aim and objectives - To evaluate and compare the clinical performance of cad cam milled endocrowns and stainless steel crowns after pulp therapy. Methodology - Children with age of 4-8 years with Frankls behavior rating scale of definitely positive (++) visiting the outpatient department of pedodontics are selected to the study. •Patient explained about the procedure and informed concern should be taken prior to start of the study. •Randomization done using randomiser software •The children will be randomly allocated to either of the groups •GROUP A (40 CHILDREN) : THE PRIMARY MOLARS RESTORED WITH STAINLESS STEEL CROWNS •GROUP B (40 CHILDREN): THE PRIMARY MOLARS RESTORED WITH CAD CAM MILLED ZIRCONIA ENDOCROWNS §Patients are then called for review at regular intervals §For examination, sufficient overhead lighting, a mouth mirror, and a sickle probe are used. §The clinical performance in terms of marginal adaptation, marginal discoloration, and marginal integrity of the restoration were scored using a United States Public Health Service (USPHS) criterion. §Alpha and Bravo scores were considered a success, while Charlie was a failure. §Dental plaque accumulation and gingival condition were assessed using Plaque Index (PI) And Gingival Index (GI). §The involved tooth was first examined for dental plaque accumulation using the naked eye and a diagnostic dental probe and scores are given.
|