Caps for milk teeth

Active, not recruiting

• Conditions: Dental caries, unspecified,

• Registration Number: CTRI/2022/10/046640
• Lead Sponsor: SelfAtharva Choudhary

Brief Summary

This is a prospective randomized parallel group study. 50 Teeth will be divided into five groups.

Group A – Preformed Zirconia Crown

Group B – Zirconia crowns milled following an intraoral scan

Group C – 3D printed resin crowns printed following an intraoral scan

Group D ­­­­­– Stainless Steel Crowns

**CLINICAL PROCEDURE**

 **Group A –Preformed Zirconia Crown**

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, rubber dam isolation followed by crown size selection will be done considering the mesio-distal width of the tooth. Removal of caries/ indicated pulp therapy, and restoration of the remaining tooth structure will be done.

·         Buccal & lingual cusps will be reduced to the depth of central grooves, maintaining cuspal inclines with the tip of a football diamond bur.

·         A football diamond bur will be used to reduce central groove by approximately 0.5mm and to prepare the buccal and lingual occlusal third of clinical crown.

·         The tip of black stripe diamond bur will be used for depth cuts of 0.5mm on the Buccal and lingual surface and for the interproximal slices of about 1mm.

·         The depth cuts will be levelled and facial/lingual interproximal line angles will be rounded.

·         A shoulder margin will be created gingivally

·         A test fit will be done with a Try-in crown

·         The shoulder margin will be removed and the preparation will be extended subgingivally to feather-edge with a green stripe diamond bur.

·         Final test fitting will be done.

·         The selected teeth will be isolated with rubber dam the preformed crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement cementation.

·         A PVS impression for the opposing jaw will be taken.

 **Group B –** **Zirconia crowns milled after an intraoral scan**

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, followed rubber dam isolation and removal of caries/indicated pulp therapy followed by restoration of the remaining tooth structure.

·         The mesial, distal, buccal, and lingual walls of the chosen teeth will be prepared 0.8-1.0 mm using a diamond bur with a round end taper so that a chamfer margin will be prepared circumferentially.

·          Each tooth’s occlusal surface will be reduced with a gap of 1.5 mm left with the opposing tooth using a round wheel diamond rotary instrument.

·         The prepared teeth will be digitally scanned with Dental Scanners, and the crowns will be designed as a full coronal restoration with the help of a software­­ to create STL files and to fabricates those crowns.

·         Crowns will be milled using Zirconia blanks with CAD/CAM system.

·         Crown trial will be done followed by evaluation of occlusion

·         The selected teeth will be isolated with rubber dam the milled crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement and cementation.

·         A PVS impression for the opposing jaw will be taken.

 **Group C –** **3D printed resin crowns printed after an intraoral scan**

·         After clinical and radiographic examination of the chosen teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, rubber dam isolation followed by removal of caries/ indicated pulp therapy, and restoration of the remaining tooth structure.

·         The mesial, distal, buccal, and lingual walls of the chosen teeth will be prepared 0.8-1.0 mm using a diamond bur with a round end taper so that a chamfer margin will be prepared circumferentially. Each tooth’s occlusal surface will be reduced with a gap of 1.5 mm left with the opposing tooth using a round wheel diamond rotary instrument.

·         The prepared teeth will be digitally scanned with Dental Scanners, and the crowns will be designed as a full coronal restoration with the help of­­ a software to create STL files and to fabricates those crowns.

·         The crowns will be manufactured via a three-dimensional dental printer utilizing a 3D printable, biocompatible, ceramic filled resin.

·         Crown trial will be done followed by evaluation of occlusion.

·         The selected teeth will be isolated with rubber dam the printed crowns will be tried and cemented in place, resin modified glass ionomer cement can              be employed to place crown with light cure, followed by application of light finger pressure.

·         Clean up and flossing will be done after crown placement and cementation.

·         A PVS impression for the opposing jaw will be taken.

**Group D –** **Stainless Steel crowns**

·         After clinical and radiographic examination of the selected teeth, treatment will be provided using the following protocol:

·         Topical anaesthetic will be applied on the region where local anaesthesia is to be given.

·         Local anesthesia using Lidocaine Hydrochloride 2% will be administered, followed rubber dam isolation and removal of caries/indicated pulp therapy followed by restoration of the remaining tooth structure.

·         The proximal surfaces will be reduced using a No. 69L bur.

·         Near-vertical reductions will be made on the proximal surfaces and carried gingivally until the contact with the adjacent tooth is broken.

·         The cusps and the occlusal portion of the tooth will then be reduced with a No. 69L bur.

·         The general contour of the occlusal surface is followed, and approximately 1 mm of clearance is kept with the opposing teeth.

·         The No. 69L bur at high speed will also be used to remove all sharp line and point angles.

·         The buccal bulge is reduced wherever necessary.

·         The smallest crown that completely covers the preparation will be chosen.

Isolation of the prepared tooth will be done before crown cementation.

Luting GIC will be prepared as per manufacturer’s instruction just prior to crown cementation.

The Stainless-Steel crown will then be filled with GIC and will be placed on the prepared crown with finger pressure.

Clean up and flossing will be done after crown placement and cementation.

A PVS impression for the opposing jaw will be taken.

 **FOLLOW UP**

Follow up of the all restorations will be set at 1 week, 3 months, 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-11
• Last Update Posted: 2024-08-10

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 1.Children reporting to the department of pediatric dentistry and belonging to the age group 4-9 years.
• 2.Children with no significant medical history.
• 3.Children indicated for receiving one or more preformed crowns on primary teeth- post-endodontic therapy, vital pulp therapy, multi surface caries restorations, patients with high caries risk, fractured teeth, teeth with extensive wear.
• 4.Teeth having adequate root support (more than 2/3rd of the root should be present).
• 5.Teeth with opposing natural teeth.

Exclusion Criteria

• 1.Parents of the child not willing to participate in the study.
• 2.Children with special health care needs.
• 3.Teeth having inadequate root support and excessive mobility.
• 4.Teeth with periapical pathology.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
There is some difference in the performance and acceptance of various types of crowns for primary teeth based on their clinical performance.	1 Week | 3 Months | 6 Months

Secondary Outcome Measures

Name	Time	Method
There is no difference in the performance and acceptance of various types of crowns for primary teeth based on their clinical performance.	1 Week

Trial Locations

Locations (1)

M A Rangoonwala College Of Dental Science & Research Centre; 🇮🇳 Pune, MAHARASHTRA, India

M A Rangoonwala College Of Dental Science & Research Centre

🇮🇳Pune, MAHARASHTRA, India

Dr Atharva A Choudhary

Principal investigator

9764553222

dr.atharvachoudhary@gmail.com