Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material

Vital Pulp Therapy Clinical Trial

Official title:

The Effect of Two Different Contemporary Chelating Agents on Vital Pulp Therapy in Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05970536
• Other study ID #: 341122
• Status: Completed
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: Sinai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial is designed to study and compare the effect of two different types of chelating agents on the vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.

Description:

1. The vital pulps exposed by caries process is treated by complete caries removal followed by full pulpotomy.

2. After hemostasis, application of apple vinegar and EDTA 17% will be used followed by MTA application. finally teeth will be restored with resin composite restoration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Presence of at least one tooth with carious pulp exposure and irreversible pulpitis.

• Cooperative behavior with no medical problem.

• Absence of tooth mobility , tenderness on percussion.

• History of pain with cold and sweets.

• Radiographically, no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal membrane space.

Exclusion Criteria:

• Teeth with pulp necrosis.

• Presence of sinus tract.

• Teeth with open apices.

• Pregnant women.

• History of intolerance of non- steroidal anti inflammatory drugs.

• Tenderness to palpation of adjacent soft tissues

Related Conditions & MeSH terms

• Pulpitis
• Vital Pulp Therapy

Intervention

Other:
• Apple vinegar or EDTA 17%
Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.

Locations

Country	Name	City	State
Egypt	Mona Rizk Abo El Wafa Ahmed	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sinai University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.	Through post operative pain assessment using Visual analogue scale (0-3) scores as 0 represents no pain, 1= mild pain, 2= moderate pain and 3= sever pain. VAS scores marked at intervals of 2,6,24,48 and 72 hours.; Clinical success criteria: Clinical parameters indicating successful treatment include the following criteria: Absence of pain except for the first 24 hours.; Normal soft tissue around the tooth ( no swelling, no sinus tract).	one year
Primary	The Pulp vitality	Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months	one year
Secondary	Radiographic success	Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include: No periapical pathosis.; No radicular resorption defects.	one year