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

Alexandria University

Status: Enrolling

Conditions: Caries Active

Treatments: Device: 3D-Printed Resin Crowns; Procedure: Bio MTA+ pulpotomy; Procedure: Endo-sequence bioceramic putty pulpotomy; Device: Stainless Steel Crowns (SSCs)

Study type: Interventional

Funder types: Other

Identifiers

NCT07344038

1155-10/2025

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 5 to 7 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children aged from 5 to 7 years. 2. Medically healthy children (ASA I) (Appendix I) 3. Positive or definitely positive behavior (Frankl's rating scale scores III or IV) (Appendix II) 4. Parents/legal guardians who provide written informed consent Tooth inclusion criteria(8, 14, 31)

  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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 4 patient groups

Endo-sequence bioceramic putty pulpotomy

Experimental group

Treatment:

Procedure: Endo-sequence bioceramic putty pulpotomy

Bio MTA+

Active Comparator group

Treatment:

Procedure: Bio MTA+ pulpotomy

3D-printed ceramic-filled hybrid resin crowns

Experimental group

Treatment:

Device: 3D-Printed Resin Crowns

Stainless steel crowns

Active Comparator group

Treatment:

Device: Stainless Steel Crowns (SSCs)