Bioceramic Putty Versus MTA in Pulpotomized Primary Teeth to be Covered With 3D Printed Resin Crowns Versus Stainless Steel Crown

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2027-04-15

Brief Summary

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children aged 5 to 7 years with deep carious second primary molars that require vital pulp therapy will be treated using either MTA or bioceramic putty, then will be fully covered using either stainless steel crowns or 3D printed resin crowns.

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Detailed Description

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removal of caries from second primary molars reaching the pulp, pulpotomy will be done by controlling the bleeding after that pulp chamber will be covered with either MTA or endosequence bioceramic putty.

resin modified glass ionomer will be placed, crown preparation will be done to receive full coverage either stainless steel crowns or 3D printed resin crowns

Conditions

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Caries Active

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endo-sequence bioceramic putty pulpotomy

Group Type EXPERIMENTAL

Endo-sequence bioceramic putty pulpotomy

Intervention Type PROCEDURE

* Profound local anesthesia and rubber dam isolation will be applied.
* Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing.
* Coronal pulp will be removed with a sharp excavator.
* Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes.
* Bioceramic putty applied directly from the manufacturer's syringe, then adapted gently with a moist cotton pellet.

Bio MTA+

Group Type ACTIVE_COMPARATOR

Bio MTA+ pulpotomy

Intervention Type PROCEDURE

* Profound local anesthesia and rubber dam isolation will be applied.
* Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing.
* Coronal pulp will be removed with a sharp excavator.
* Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes.
* The MTA powder will be mixed with the liquid to a putty consistency and applied with an amalgam carrier.

3D-printed ceramic-filled hybrid resin crowns

Group Type EXPERIMENTAL

3D-Printed Resin Crowns

Intervention Type DEVICE

* Tooth preparation: 1 mm axial reduction with a chamfer finish line using tapered diamond stone with round end (Mani TR-12) for buccal, lingual, mesial, and distal walls.
* One and half - 2 mm occlusal reduction.
* Digital impressions using IOS scanning, including occlusion and antagonist.
* 3D printed resin crowns will be designed using the Exocad software (Exocad Rigeka 3.1) to have a uniform thickness on all surfaces (average 1 mm), including occlusal, buccal, lingual, and proximal surfaces. After reviewing each design, it will be exported as a high-resolution STL file (standard tessellation language) to be outsourced and 3D printed.
* BEGO DLP printer will be utilized to print the crowns using VarseoSmile Trinique resin via digital light processing (DLP) technique.
* After printing, the platform will be removed from the 3D printer and placed on a paper towel with the printed crowns facing upward.
* The printed crowns will be separated from the platform and rinsed tw

Stainless steel crowns

Group Type ACTIVE_COMPARATOR

Stainless Steel Crowns (SSCs)

Intervention Type DEVICE

* Occlusal reduction of 1.0-1.5 mm using a flame-shaped diamond bur.
* Interproximal slicing to enable passive crown placement.
* Crown size selection based on best fit.
* Cementation using RMGIC.
* Excess cement will be removed.

Interventions

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Endo-sequence bioceramic putty pulpotomy

* Profound local anesthesia and rubber dam isolation will be applied.
* Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing.
* Coronal pulp will be removed with a sharp excavator.
* Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes.
* Bioceramic putty applied directly from the manufacturer's syringe, then adapted gently with a moist cotton pellet.

Intervention Type PROCEDURE

Bio MTA+ pulpotomy

* Profound local anesthesia and rubber dam isolation will be applied.
* Carious tissue will be completely removed using diamond burs until pulp exposure and deroofing.
* Coronal pulp will be removed with a sharp excavator.
* Hemostasis will be achieved with a saline-moistened cotton pellet for 5 minutes.
* The MTA powder will be mixed with the liquid to a putty consistency and applied with an amalgam carrier.

Intervention Type PROCEDURE

Stainless Steel Crowns (SSCs)

* Occlusal reduction of 1.0-1.5 mm using a flame-shaped diamond bur.
* Interproximal slicing to enable passive crown placement.
* Crown size selection based on best fit.
* Cementation using RMGIC.
* Excess cement will be removed.

Intervention Type DEVICE

3D-Printed Resin Crowns

* Tooth preparation: 1 mm axial reduction with a chamfer finish line using tapered diamond stone with round end (Mani TR-12) for buccal, lingual, mesial, and distal walls.
* One and half - 2 mm occlusal reduction.
* Digital impressions using IOS scanning, including occlusion and antagonist.
* 3D printed resin crowns will be designed using the Exocad software (Exocad Rigeka 3.1) to have a uniform thickness on all surfaces (average 1 mm), including occlusal, buccal, lingual, and proximal surfaces. After reviewing each design, it will be exported as a high-resolution STL file (standard tessellation language) to be outsourced and 3D printed.
* BEGO DLP printer will be utilized to print the crowns using VarseoSmile Trinique resin via digital light processing (DLP) technique.
* After printing, the platform will be removed from the 3D printer and placed on a paper towel with the printed crowns facing upward.
* The printed crowns will be separated from the platform and rinsed tw

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Deep carious second primary molars with:

1. Vital pulp confirmed by absence of clinical and/or radiographic signs of necorosis or infection.
2. Signs of reversible pulpitis. 10
2. Require full coverage restorations
3. Cooperative children (Frankl 3 or 4 behavior rating scale)

Exclusion Criteria

* History of spontaneous pain. 2. Tooth mobility. 3. Excessive bleeding from radicular stumps after coronal pulp amputation. 4. Radiographic evidence of pathological root resorption, inter-radicular bone loss, periapical pathology, or canal calcifications. 5. Previous dental treatment of the involved molar. 6. Children with special healthcare needs.

Minimum Eligible Age

5 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No