Outcome of Full Pulpotomy Using Calcium Silicate Based Materials (pulpotomy)

Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Carious Teeth
• Intervention / Treatment: Procedure: MTA pulpotomy

Detailed Description

• The target sample size is 150 patients medically fit, having vital teeth with carious pulp exposure and complaining of pain.
• The patients tooth will receive full pulpotomy under aseptic conditions and it will be randomly assigned to one of 3 calcium silicate based materials namely, (Mineral trioxide Aggregate (MTA), Biodentine, and Bioceramic for capping the full pulpotomy followed by resin composite restoration.
• Follow up for pain levels will be done during the first week.
• clinical and radiographic examination will be done at 6 months, 1 year and yearly up to 5 years.
• Success of the procedure includes absence of clinical signs and symptoms, with absence of pathology in the root and periapex on periapical radiographs.
• The 3 materials will be compared in terms of clinical and radiographic outcomes.
• demographic data of the three groups will be also compared
• predictive factors of success will be also analyzed
• tooth color changes will be also measured using vita easy shade and will compared between the groups at 6 months and 1 year.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • IRbid, Jordan, 21110
    • Dental teaching centre Faculty Of Dentistry
  • Irbid, Jordan, 22110
    • Jordan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MTA pulpotomy; Tooth will receive MTA & resin composite restoration	Procedure: MTA pulpotomy; Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration; Other Names: Biodentine pulpotomy and Bioceramic pulpotomy
Active Comparator: Biodentine pulpotomy; Tooth will receive Biodentine & resin composite restoration	Procedure: MTA pulpotomy; Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration; Other Names: Biodentine pulpotomy and Bioceramic pulpotomy
Active Comparator: Bioceramic pulpotomy; Tooth will receive Bioceramic & resin composite restoration	Procedure: MTA pulpotomy; Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration; Other Names: Biodentine pulpotomy and Bioceramic pulpotomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic normalcy	Absence of pathology in the root and the bone surrounding the apex	1 year and yearly up to 5 years

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): May 2, 2018
• Study Completion (Anticipated): May 2, 2023

Study Registration Dates

• First Submitted: April 9, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: teeth, caries, pulpotomy, MTA, biodentine, bioceramic
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 503/2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Detailed participants data will be released within the publications resulting from the trial with reference to the registration number of the study. If further details are required the principal investigator. can be contacted via email.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No