Outcome of Full Pulpotomy Using Calcium Silicate Based Materials

Carious Teeth Clinical Trial

— pulpotomy  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04345263
• Other study ID #: 503/2017
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: May 2, 2024

Study information

• Verified date: May 2024
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: May 2, 2024
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Carious Teeth
• Dental Caries

Intervention

Procedure:
• MTA pulpotomy
Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration

Locations

Country	Name	City	State
Jordan	Dental teaching centre Faculty Of Dentistry	IRbid
Jordan	Jordan University of science and technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Radiographic normalcy	Absence of pathology in the root and the bone surrounding the apex	1 year and yearly up to 5 years