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

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

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.

Study Overview

• Status: Completed
• Conditions: Vital Pulp Therapy
• Intervention / Treatment: Other: Apple vinegar or EDTA 17%

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Mona Rizk Abo El Wafa Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apple vinegar group; After hemostasis of the exposed pulp is achieved, Apple vinegar will be used for dentin conditioning for 5 mins then 1-2 mm thickness of MTA placed on the exposed pulp chamber.	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.
Active Comparator: EDTA 17% group; After hemostasis of the exposed pulp is achieved, EDTA 17 % will be used for dentin conditioning then 1-2 mm thickness of MTA placed on the exposed pulp chamber.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic success	Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include: No periapical pathosis.; No radicular resorption defects.	one year

Collaborators and Investigators

• Sponsor: Sinai University
• Investigators: Principal Investigator: Mona R Abo El Wafa Ahmed, PhD, Faculty of Dentistry, Sinai University.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 8, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis; Anti-Infective Agents; Anti-Bacterial Agents; Acetic Acid
• Other Study ID Numbers: 341122

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: 2 years
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

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