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

NCT05970536 | Completed

• 1 other identifier: 341122
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Vital Pulp Therapy

Outcome Measures

Primary Outcomes (2)

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

  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).

  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 Outcomes (1)

• Radiographic success

  one year

Study Arms (2)

Apple vinegar group

EXPERIMENTAL

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%

EDTA 17% group

ACTIVE COMPARATOR

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%

Interventions

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.

Apple vinegar group; EDTA 17% group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sinai University: lead

Study Sites (1)

Mona Rizk Abo El Wafa Ahmed

Cairo, Egypt

Location

Related Publications (1)

• Sobh YTM, Ahmed MRA. The effect of two different contemporary chelating agents on vital pulp therapy in mature permanent teeth with irreversible pulpitis using bioceramic material: randomized clinical trial. BMC Oral Health. 2024 Aug 8;24(1):918. doi: 10.1186/s12903-024-04627-6.

  PMID: 39118082 DERIVED

Study Officials

• Mona R Abo El Wafa Ahmed, PhD

  Faculty of Dentistry, Sinai University.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: double ( participant, outcome assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Parallel double blinded.

Study Record Dates

• First Submitted: July 8, 2023
• First Posted: August 1, 2023
• Study Start: December 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 18, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years

Locations

EG (1)