Tooth Discoloration Induced by Pulpotomy Materials

NCT04346849 | Active Not Recruiting DMC

• 1 other identifier: 5/2018
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 2

Brief Summary

Vital pulp therapy including pulpotomy is commonly used for managing teeth with carious pulp exposure instead of performing root canal therapy. The gold standard materials used in this procedure are the calcium silicate based materials, however recent case reports have shown tooth discoloration caused by these materials especially MTA which is of concern to the patients. The aim of this study is to compare tooth color changes and discoloration induced by 3 calcium silicate based materials used in pulpotomy over 6 months, 12 months and yearly up to 5 years.

Conditions

Tooth Discoloration

Keywords

Pulpotomy, MTA, Biodentine, Bioceramic, discoloration

Outcome Measures

Primary Outcomes (1)

• Tooth color change

  Darkening in tooth color shade after placement of the calcium silicate based material

  Immediate, 6 months, 1 year and yearly up to 5 years

Study Arms (3)

MTA pulpotomy

EXPERIMENTAL

Teeth receiving pulpotomy using MTA

Procedure: Pulpotomy

Biodentine pulpotomy

EXPERIMENTAL

Teeth receiving pulpotomy using Biodentine

Procedure: Pulpotomy

Bioceramic pulpotomy

EXPERIMENTAL

Teeth receiving pulpotomy using Bioceramic

Procedure: Pulpotomy

Interventions

Pulpotomy PROCEDURE

Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration

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:

• Vital tooth with carious pulp exposure to be treated by full pulpotomy
• Fully erupted upper or lower molar tooth with fully formed apex
• Tooth should have intact buccal wall (no caries or restoration)
• Tooth should be restorable by direct composite restoration

You may not qualify if:

• Partially erupted tooth
• Tooth has caries on the buccal surface
• Tooth has restoration on buccal surface
• Tooth has preoperative coronal staining compared to adjacent teeth

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, Hamdan AM, Al-Hiyasat AS. Coronal discoloration induced by calcium silicate-based cements used in full pulpotomy in mature permanent molars: a randomized clinical trial. Clin Oral Investig. 2023 Apr;27(4):1723-1730. doi: 10.1007/s00784-022-04799-x. Epub 2022 Nov 29.

  PMID: 36445467 DERIVED

MeSH Terms

Conditions

Tooth Discoloration

Interventions

Pulpotomy

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

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, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant will not be informed about the type of material. Investigator will be given the material only after the pulpotomy procedure was completed according to a random sequence number generator. Upon tooth color measurement the investigator will not be informed about the type of material
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Three groups will receive the same treatment procedure but randomly assigned to one of three different materials, tooth color changes will be measured at certain time points and will be compared between the 3 groups.

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: September 2, 2017
• Primary Completion: May 2, 2018
• Study Completion: May 2, 2025
• Last Updated: May 2, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

JO (2)