Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

NCT04345263 | Active Not Recruiting DMC

• 1 other identifier: 503/2017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

Permanent teeth with carious pulp exposure and indicated for full pulpotomy will be treated using three different materials using aseptic technique and will be subsequently followed up clinically and radiographically at 6 months, 1 year and yearly up to 5 years.

Conditions

Carious Teeth

Keywords

teeth, caries, pulpotomy, MTA, biodentine, bioceramic

Outcome Measures

Primary Outcomes (1)

• Degree of pain relief after treatment compared to preoperative pain level

  Absence of symptoms or significant pain reduction within the first week after treatment as measured on a numerical scale from 0 to 10 where zero means no pain and 10 is the most sever pain. Visual analogue scale will be also used.

  1 week

Secondary Outcomes (1)

• Radiographic normalcy

  1 year and yearly up to 5 years

Study Arms (3)

MTA pulpotomy

ACTIVE COMPARATOR

Tooth will receive MTA \& resin composite restoration

Procedure: MTA pulpotomy

Biodentine pulpotomy

ACTIVE COMPARATOR

Tooth will receive Biodentine \& resin composite restoration

Procedure: MTA pulpotomy

Bioceramic pulpotomy

ACTIVE COMPARATOR

Tooth will receive Bioceramic \& resin composite restoration

Procedure: MTA pulpotomy

Interventions

MTA pulpotomy PROCEDURE

Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Also known as: Biodentine pulpotomy and Bioceramic pulpotomy

Bioceramic pulpotomy; Biodentine pulpotomy; MTA pulpotomy

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mature permanent tooth with carious lesion exposing the pulp,
• Positive response to cold test
• Clinical Diagnosis of reversible or irreversible pulpitis
• Restorable tooth by direct restoration or crown
• Healthy patient

You may not qualify if:

• Non vital teeth
• Teeth without pulp exposure
• Inability to achieve hemostasis within 10 min after pulpotomy
• Non restorable teeth or teeth that require post and core restoration

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (2)

Dental teaching centre Faculty Of Dentistry

Irbid, 21110, Jordan

Location

Jordan University of science and technology

Irbid, 22110, Jordan

Location

Related Publications (1)

• Taha NA, Al-Rawash MH, Imran ZA. Outcome of full pulpotomy in mature permanent molars using 3 calcium silicate-based materials: A parallel, double blind, randomized controlled trial. Int Endod J. 2022 May;55(5):416-429. doi: 10.1111/iej.13707. Epub 2022 Mar 17.

  PMID: 35152464 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nessrin Taha, DCD

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patient unaware of the material to be used, care provider will be given the material after performing full pulpotomy . Tooth crown will be masked during assessment of radiographs
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 14, 2020
• Study Start: September 1, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)