Skip to main content
OpenTrials
Completed

NCT Number: NCT05970536

Vital Pulp Therapy of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vital Pulp Therapy

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mona Rizk Abo El Wafa Ahmed

Cairo, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apple vinegar or EDTA 17%

Other

Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.

Primary outcomes

  1. Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.

    Time frame: one year

    • 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).

  2. The Pulp vitality

    Time frame: one year

    Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months

Secondary outcomes

  1. Radiographic success

    Time frame: one year

    Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:

    • No periapical pathosis.
    • No radicular resorption defects.

Sponsors and collaborators

Lead sponsor

Sinai University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.