Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

Not Applicable

Active, not recruiting

• Conditions: Carious Teeth
• Interventions: Procedure: MTA pulpotomy

• Registration Number: NCT04345263
• Lead Sponsor: Jordan University of Science and Technology

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.

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 Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-05-02
• Study First Submitted: 2020-04-09
• Study First Submitted QC: 2020-04-12
• Study First Posted: 2020-04-14
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-01
• Study Completion: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MTA pulpotomy	MTA pulpotomy	Tooth will receive MTA \& resin composite restoration
Biodentine pulpotomy	MTA pulpotomy	Tooth will receive Biodentine \& resin composite restoration
Bioceramic pulpotomy	MTA pulpotomy	Tooth will receive Bioceramic \& resin composite restoration

Primary Outcome Measures

Name	Time	Method
Degree of pain relief after treatment compared to preoperative pain level	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Radiographic normalcy	1 year and yearly up to 5 years	Absence of pathology in the root and the bone surrounding the apex

Trial Locations

Locations (2)

Jordan University of science and technology; 🇯🇴 Irbid, Jordan

Dental teaching centre Faculty Of Dentistry; 🇯🇴 IRbid, Jordan