CTRI

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CTRI Number

CTRI/2025/05/086735 [Registered on: 13/05/2025] Trial Registered Prospectively

Last Modified On:

15/05/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Follow Up Study

Study Design

Other

Public Title of Study

Evaluation of occlusal bite forces crowns cemented on pulpectomized primary molars

Scientific Title of Study

Evaluation of occlusal bite forces and the outcomes of preformed stainless-steel crowns cemented on pulpectomized primary molars

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 Girish Babu KL
Designation	Professor and Head
Affiliation	Hassan Institute of Medical sciences
Address	Room no 20, Department of Dentistry, Hassan Institute of Medical Sciences, Hassan KARNATAKA 573201 India
Phone	09845340753
Fax
Email	docgirish77@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Girish Babu KL
Designation	Professor and Head
Affiliation	Hassan Institute of Medical sciences
Address	Department of Dentistry, Hassan Institute of Medical Sciences, Hassan KARNATAKA 573201 India
Phone	09845340753
Fax
Email	docgirish77@gmail.com

Details of Contact Person
Public Query

Name	Dr Girish Babu KL
Designation	Professor and Head
Affiliation	Hassan Institute of Medical sciences
Address	Department of Dentistry, Hassan Institute of Medical Sciences, Hassan KARNATAKA 573201 India
Phone	09845340753
Fax
Email	docgirish77@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor
Modification(s)

Name	Girish Babu KL
Address	Room no 20, Department of Dentistry Hassan Institute of Medical Sciences, Hassan-573201, Karnataka, India
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 GIRISH BABU KL	Hassan Institute of Medical Sciences	Room no: 20 Department of Dentistry Hassan KARNATAKA	09845340753 docgirish77@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee- HIMS,Hassan	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Normal, Healthy co-operative children

Intervention / Comparator Agent

Type	Name	Details
Intervention	Nil	Nil

Inclusion Criteria

Age From	4.00 Year(s)
Age To	6.00 Year(s)
Gender	Both
Details	1. Normal, healthy and cooperative children aged 4-6 years 2. Indian children with primary dentition stage 3. Children requiring pulpectomy for their primary molars 4. End on/Mesial step primary second molar relationship 5.Children without any facial asymmetry, crossbite or open bite that could affect bite recording 6. Absence of gingival inflammation or periodontal disease 7. Absence of preshedding or pathological mobility of the teeth 8. Children without any pre-existing medical conditions. 9. Absence of pain on biting 10. Children without any previous restorations 11. Children with absence of parafunctional habits

ExclusionCriteria

Details

1. Children with special health care needs
2. Uncooperative children
3. Children with missing teeth in the region of recording

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome

TimePoints

1.To evaluate and compare the occlusal bite force and Body Mass Index before and after the cementation of preformed stainless-steel crowns on pulpectomized primary molars.
2.To correlate the BMI index and occlusal bite force of children following cementation of preformed stainless-steel crowns on pulpectomized primary molars.
4.To evaluate the outcome of preformed stainless-steel crowns cemented on pulpectomized primary molars.

The occlusal bite force of these pulpectomized teeth that have received the preformed stainless-steel crowns will be assessed at end of 1st week, 1st month, 2nd month, 3rd month, 4th month, 5th month and 6th month

Secondary Outcome

Outcome	TimePoints
1. To evaluate & compare the occlusal bite force before & after cementation of preformed stainless-steel crowns of maxillary primary first molar on pulpectomized contralateral mandibular primary first molar.	1The occlusal bite force of these pulpectomized teeth that have received the preformed stainless-steel crowns will be assessed at end of 1st week, 1st month, 2nd month, 3rd month, 4th month, 5th month & 6th month

Target Sample Size

Total Sample Size="360"
Sample Size from India="360"
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)

27/05/2025

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="3"
Months="0"
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

Procedure Protocol

Objective 1: The occlusal bite force before and after the cementation of preformed stainless-steel crowns on pulpectomized primary molars

The selected 200 children will be grouped according to the treatment needs.

Evaluation of BMI: Anthropometric measurements, such as body weight and height, will be recorded for all children. The BMI value will be plotted on age- and gender-specific charts from the Centre for Disease Control and Prevention 2000. Children will be categorized as underweight, normal weight, at risk of overweight, or overweight based on these percentile curves.

Recording of occlusal bite force: The occlusal bite force will be measured bilaterally in the first and second primary molars region using a battery-operated portable type gauge (GM10, Nagano Keiki, Tokyo, Japan) that consists of a hydraulic pressure gauge and a biting element made of a vinyl material encased in a polyethylene tube. The measured occlusal bite force will be calculated in Newtons that is displayed digitally.

Procedure of Pulpectomy: The conventional pulpectomy procedure will be performed on selected and grouped primary molars.

Procedure for placement of preformed stainless-steel crowns: The crown size selection will be trial and error method.²³ Tooth preparation for placement of preformed crowns will be carried-out according to Mink and Bennet technique.

Recording of occlusal bite force: The occlusal bite force of these pulpectomized teeth that have received the preformed stainless-steel crowns will be assessed at end of 1^st week, 1^st month, 2^nd month, 3^rd month, 4^th month, 5^th month and 6^th month as described earlier.

Evaluation of BMI: The evaluation of BMI will be reassessed at the end of 6^th month as described earlier.

Evaluation of outcome of preformed stainless-steel crowns: The outcome of the preformed stainless-steel crowns will be evaluated clinically for gingival health, extent of crown is high in bite, surface roughness, staining of the crown, wear of the opposing arch tooth (except for Group 5,6 and 7), anatomic form, marginal discoloration, proximal contact area, and secondary caries.²⁰ All the parameters will be scored as follows: clinically ideal (A-Alpha), clinically acceptable (B-Bravo), and clinically unacceptable (C-Charlie). Further, durability of the crown (presence of crown till the end of study period, treated tooth extracted due to pulpal pathology and need for preformed crown replacement) will be assessed.²⁶ The outcome of the preformed stainless-steel crowns will be assessed for the above-mentioned parameters at end of 3^rd month, 6^th month, 12^th month, 18^th month, 24^th month, 30^th month, and 36^th month.

The evaluation of BMI, conducting of pulpectomy, tooth preparation and cementation of preformed stainless-steel crown and clinical performance of the preformed crowns will be performed by a single pediatric dentist. The data obtained will be subjected to statistical analysis.