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CTRI Number  CTRI/2024/12/077894 [Registered on: 10/12/2024] Trial Registered Prospectively
Last Modified On: 10/12/2024
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 Success, Plaque retention, Gingival health Patient satisfaction between Preformed stainless steel crowns and Bioflex crowns in children of 4-8 years 
Scientific Title of Study   Comparative Evaluation of Clinical Success with Preformed Stainless Steel Crowns and Bioflex Crowns 9 Month Follow up 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  Nikhitha Elsa Shaji 
Designation  Student 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE, TUMKUR 
Address  Department of Pedodontics, Sri Siddhartha Dental College, Tumkur

Tumkur
KARNATAKA
572107
India 
Phone  9495639631  
Fax    
Email  nikielsa97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jyothsna V Setty 
Designation  Professor and HOD 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE, TUMKUR 
Address  Department of Pedodontics, Sri Siddhartha Dental College, Tumkur


KARNATAKA
572107
India 
Phone  9495639631  
Fax    
Email  jyothsnasrikanth@gmail.com  
 
Details of Contact Person
Public Query  
Name  Nikhitha Elsa Shaji 
Designation  Student 
Affiliation  SRI SIDDHARTHA DENTAL COLLEGE, TUMKUR 
Address  Department of Pedodontics, Sri Siddhartha Dental College, Tumkur


KARNATAKA
572107
India 
Phone  9495639631  
Fax    
Email  nikielsa97@gmail.com  
 
Source of Monetary or Material Support  
Sri Siddhartha Dental College, Tumkur, Karnataka,India 572107 
 
Primary Sponsor  
Name  Nikhitha Elsa Shaji 
Address  Department of Pedodontics, Sri Siddhartha Dental College, Tumkur, Karnataka, India 572107 
Type of Sponsor  Other [Self] 
 
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 Nikhitha Elsa Shaji  Sri Siddhartha Dental College, Tumkur  Department of Pedododntics, Sri Siddhartha Dental College, Tumkur
Tumkur
KARNATAKA 		 9495639631

nikielsa97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SIDDHARTHA DENTAL COLLEGE AND HOSPITAL INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BIOFLEX CROWNS  Evaluating the clinical success of Bioflex crowns and comparing it with the control group-9 month follow up 
Comparator Agent  STAINLESS STEEL CROWNS  Evaluating the clinical success of Bioflex crowns and comparing it with stainless steel crowns group 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  8.00 Year(s)
Gender  Both 
Details  1. Children in the age group between 4 to 8 years
indicated for pulpectomy
2. Cooperative children
3. Lower second primary molars after pulpectomy
procedure.
4. Lower second primary molars having two thirds
of root structure left radiographically.
 
 
ExclusionCriteria 
Details  1. Uncooperative children (Frankl behavior:
definitely negative)
2. Tooth mobility
3. A pathological root resorption
4. Primary molars not having sufficient crown
structure
•Primary molars with root caries 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Crown retention will be evaluated as intact/displaced, chipped/broken/fracture, complete loss of crown.
2.Stain resistance will be evaluated as no staining, minor staining and noticeable staining.
3. Opposing tooth will be evaluated as wear, no wear.
4. Marginal integrity will be determined through visible inspection and tactile examination with an explorer as closed margin and open margin.
5. Proximal contact area between the first and second molar will be recorded as intact or lost by passing a dental floss.
6. Clinician satisfaction criteria will be evaluated as surface gloss, roughness, aesthetic and anatomical form using five-point Likert’s scale.
7. Children’s acceptance to the treatment will be evaluated by the Smiley scale
 		 3, 6 and 9 months follow up
 
 
Secondary Outcome  
Outcome  TimePoints 
Gingival status
Periodontal status 		 3, 6, 9 months follow up 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   23/12/2024 
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="9"
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   Dental caries is a public health concern especially in children and young adolescents. Preformed metal crowns also known as Stainless steel crowns is a gold standard for posterior full coverage restorations. Due to technological advancement, a flexible, esthetically appealing crown- Bioflex crowns has been introduced. This randomized control trial is done to evaluate clinical success, clinician and patient satisfaction between two groups- Group A: Stainless steel crowns and Group B: Bioflex Crowns. This study will be conducted in 20 children who require pulpectomy procedure for the lower second primary molars, visiting the department of Pedodontics, Sri Siddhartha dental college, Tumkur. Crown preparation will be done according to the manufacturer’s instruction. the crown will be placed using the type 1 glass ionomer cement. There will be a follow up period of 1 week, 3 months, 6 months and 9 months to evaluate the clinical success between the two groups. Plaque retention will be evaluated using Sillness-Loe Plaque index and gingival index will be evaluated using  Loe-Sillness gingival index. Clinical success will be evaluating by assessing the marginal integrity, opposite tooth wear, crown retention, stain resistance and proximal contact area, during the follow up period. Pain and anxiety of the patient will be evaluated using the Animated emoji scale and Venham Picture test during the pre-op and post op periods and FLACC scale during the treatment. Clinician satisfaction will be evaluated by assessing the time taken during the placement of the crowns and by 5 point Likert scale assessing the surface gloss, roughness aesthetic and anatomical form after the treatment and during follow up. 
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