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CTRI Number  CTRI/2024/09/073181 [Registered on: 02/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative evaluation of CAD-CAM milled Polymethyl methacrylate Zirconia crown in primary maxillary incisors in 3-6 year old children – A Split mouth Randomized clinical study. 
Scientific Title of Study   Comparative evaluation of CAD-CAM milled custom made Polymethyl methacrylate crown and custom made Zirconia crown in primary maxillary incisors in 3-6 year old children – A Split mouth Randomized clinical 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 Aditi Oza 
Designation  Post graduate student 
Affiliation  Sinhgad dental college and hospital  
Address  S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 Department of pediatric and preventive dentistry, number 6, -1 floor
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 Department of pediatric and preventive dentistry, number 6, -1 floor
Pune
MAHARASHTRA
411041
India 
Phone  9730304242  
Fax    
Email  aditioza82@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhagyashree Sakunkhe  
Designation  Professor 
Affiliation  Sinhgad dental college and hospital  
Address  S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 Department of pediatric and preventive dentistry, number 6, -1 floor
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 Department of pediatric and preventive dentistry, number 6, -1 floor
Pune
MAHARASHTRA
411041
India 
Phone  9922203344  
Fax    
Email  b.salunkhe@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aditi Oza 
Designation  Post graduate student 
Affiliation  Sinhgad dental college and hospital  
Address  S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 department of pediatric and preventive dentistry, number 6, -1 floor
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 department of pediatric and preventive dentistry, number 6, -1 floor
Pune
MAHARASHTRA
411041
India 
Phone  9730304242  
Fax    
Email  aditioza82@gmail.com  
 
Source of Monetary or Material Support  
S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041,India, department of pediatric and preventive dentistry, number 6, -1 floor  
 
Primary Sponsor  
Name  Dr Aditi Oza 
Address  S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041 
Type of Sponsor  Other [Funded by the post graduate student ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR ADITI OZA   SINHGAD DENTAL COLLGE ADN HOSPITAL , PUNE  S. No. 44/1, Vadgaon Budruk, 0ff, Sinhgad Rd, Pune, Maharashtra 411041, department of pediatric and preventive dentistry, number 6, -1 floor, India
Pune
MAHARASHTRA 		 9730304242

aditioza82@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE SINHGAD DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  OTHER SPECIFIED DISORDERS OF TEETH AND SUPPORTING TISSUES  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Polymethyl methacrylate crowns   One of the options available apart from the routine tooth-colored restorations is the polymethyl methacrylate crowns, these are made of polycarbonate resin shells with micro-glass fibres and have been used to restore childrens teeth. Advantages of acrylic crowns include slightly translucent, tooth colored and cost effective duration of intervention: 6 months 
Comparator Agent  Zirconia crowns  Zirconia is a crystalline dioxide of zirconium provides a natural appearance to the restored teeth. Zirconia has also been considered as an ideal material for the fabrication of the naturally contoured crowns due to its higher fracture and mechanical strength, and superior volume and chemical stability than previously available dental ceramics.  
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  a. Children of age 3 – 6 years
b. Primary maxillary incisors indicated for crowns with minimum of 1-2 mm of tooth structure present above the gingival margin
c. Sound antagonist teeth
d. Children who are healthy and don’t require special health care
e. No deleterious oral habits
 
 
ExclusionCriteria 
Details  a. Children with presence of systemic diseases that require special heath care
b. Primary maxillary incisors treated with post and core
c. Extensively decayed primary maxillary incisors with presence of root stumps
d. Children who have parafunctional habits such as bruxism
e. Teeth with proximity to exfoliation and resorption of root passed its half of length
 
 
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 Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
a. Gingival health -Loe H and Silness P Index (1963)
b. Plaque accumulation-Silness P and Loe H Index (1967)

 		 AT 1 3 AND 6 MONTHS
 
 
Secondary Outcome  
Outcome  TimePoints 
c. Parental acceptability- 5 point Likert scale
d. Restoration failure- USPHS Alpha rating criteria(1980)
e. Marginal integrity- Modified USPHS Alpha rating criteria
 		 AT 1 3 AND 6 MONTHS  
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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   Phase 3 
Date of First Enrollment (India)   09/09/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/09/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response (Others) -  NONE

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) -  NONE
  3. Who will be able to view these files?
    Response (Others) -  NONE

  4. For what types of analyses will this data be available?
    Response (Others) -  NONE

  5. By what mechanism will data be made available?
    Response (Others) -  NONE

  6. For how long will this data be available start date provided 14-11-2025 and end date provided 14-11-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

•       At the start of the study, 38 patients will be selected according to the inclusion and exclusion criteria after acquiring consent from the parents.

•       38 patients will be divided into two groups randomly, 19 patients each (19 teeth on right and 19 on the left)

Group A- CAD-CAM milled custom made Polymethyl methacrylate crown

Group B- CAD-CAM milled custom made Zirconia crowns

 

Brief medical and dental history of the patient in the presence of child’s parent or guardian will be recorded. For every selected patient oral prophylaxis will be performed.

•       After the teeth selection, caries excavation would be done followed by tooth preparation. In both the groups, principles followed for the tooth preparation will be similar.

GROUP A :

Tooth will be prepared to receive CAD-CAM milled custom made Polymethyl methacrylate crown.

A coarse tapered round diamond bur will be used to reduce the incisal edge, mesial, distal, labial and palatal surfaces by 1mm. A torpedo diamond bur will be used for preparing a thin chamfer margin placed equigingivally. The finishing of the tooth preparation will be done by using a fine tapered diamond bur. After the tooth preparation is completed, maxillary impression will be made by using condensation silicone impression material and mandibular impression by using alginate impression material. The impressions would be poured by using dental stone and the casts made would then be retrieved and trimmed accordingly. The casts would be sent to the dental laboratory for fabrication of crown on the respective teeth. The fabricated crown will then be completely air dried and filled with Type I luting Glass Ionomer Cement and cemented. Excess of the cement was removed using an explorer and floss


•       In GROUP B:

Tooth will be prepared to receive custom made Zirconia crown. A coarse tapered round diamond bur will be used to reduce the incisal edge, labial palatal, mesial and distal surfaces by approximately 1-1.5mm. A torpedo diamond bur will be used to provide a deep chamfer finish margin which would be prepared supragingivally.  The finishing of the tooth preparation will be done by using a fine tapered diamond bur. After the tooth preparation is completed, maxillary impression will be made by using condensation silicone impression material and mandibular impression by using alginate impression material. The impressions would be poured by using dental stone and the casts made would then be retrieved and trimmed accordingly. The casts would be sent to the dental laboratory for fabrication of crown on the respective teeth. The fabricated crown will then be completely air dried and filled with Type I luting Glass Ionomer Cement and cemented. Excess of the cement was removed using an explorer and floss.

Standard postoperative instructions, including oral hygiene guidelines and dietary requirements, such as avoiding sticky foods to prevent the dislodgement of crowns were given

•       The evaluation of the teeth restored with crowns at follow-up visits will be done at 1 month, 3 months and 6 months respectively by calibrated examiner. The patients will be evaluated clinically according to the following criteria:

a.     Gingival health -Loe H and Silness P Index (1963)

b.     Plaque accumulation-Silness P and Loe H Index (1967)

c.     Parental acceptability- 5 point Likert scale

d.     Restoration failure- USPHS Alpha rating criteria(1980)

e.     Marginal integrity-  Modified USPHS Alpha rating criteria

The absence or presence of these evaluation criteria at the end of 1 month, 3 months and 6 months will be used for determination of cumulative success and failure of crowns respectively
 
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