Clinical trial NCT04345263: Outcome of Full Pulpotomy Using Calcium Silicate Based Materials
Official title: Outcome of Full Pulpotomy in Permanent Teeth With Carious Pulp Exposure, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Carious Teeth
Keywords: teeth, caries, pulpotomy, MTA, biodentine, bioceramic
Lead sponsor: Jordan University of Science and Technology
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 150
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Degree of pain relief after treatment compared to preoperative pain level
timeFrame: 1 week
Secondary outcomes:
measure: Radiographic normalcy
timeFrame: 1 year and yearly up to 5 years
Other outcomes:
Locations:
city: IRbid
country: Jordan
facility: Dental teaching centre Faculty Of Dentistry
city: Irbid
country: Jordan
facility: Jordan University of science and technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Nessrin Taha, DCD
role: STUDY_CHAIR
References:
citation: 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.