Evaluation of occlusal bite forces crowns cemented on pulpectomized primary molars

Not yet recruiting

Conditions: Normal, Healthy co-operative children

Registration Number: CTRI/2025/05/086735

Lead Sponsor: Girish Babu KL

Brief Summary: **Procedure Protocol**

**Objective 1:** **T****he 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 1st week, 1st month, 2nd month, 3rd month, 4th month, 5th month and 6th month as described earlier.

**Evaluation of BMI:**The evaluation of BMI will be reassessed at the end of 6th 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 3rd month, 6th month, 12th month, 18th month, 24th month, 30th month, and 36th 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

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.
Absence of pain on biting 10.
Children without any previous restorations 11.

Exclusion Criteria

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

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.To correlate the BMI index and occlusal bite force of children following cementation of preformed stainless-steel crowns 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
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
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.	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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Hassan Institute of Medical Sciences
🇮🇳
Hassan, KARNATAKA, India
Hassan Institute of Medical Sciences
🇮🇳Hassan, KARNATAKA, India
DR GIRISH BABU KL
Principal investigator
09845340753
docgirish77@gmail.com