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

Not Applicable

Completed

• Conditions: Vital Pulp Therapy
• Interventions: Other: Apple vinegar or EDTA 17%

• Registration Number: NCT05970536
• Lead Sponsor: Sinai University

Brief 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.

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 Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-07
• Study First Submitted: 2023-07-08
• Study First Submitted QC: 2023-07-23
• Study First Posted: 2023-08-01
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apple vinegar group	Apple vinegar or EDTA 17%	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.
EDTA 17% group	Apple vinegar or EDTA 17%	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.

Primary Outcome Measures

Name	Time	Method
Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.	one year	1. 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.; 2. 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).
The Pulp vitality	one year	Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months

Secondary Outcome Measures

Name	Time	Method
Radiographic success	one year	Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include: * No periapical pathosis.; * No radicular resorption defects.

Trial Locations

Locations (1)

Mona Rizk Abo El Wafa Ahmed; 🇪🇬 Cairo, Egypt