Back to resultsVital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
Primary Purpose
Vital Pulp Therapy
Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Apple vinegar or EDTA 17%
Sponsored by
About this trial
This is an interventional treatment trial for Vital Pulp Therapy
Eligibility Criteria
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
Sites / Locations
- Mona Rizk Abo El Wafa Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Apple vinegar group
EDTA 17% group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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).
The Pulp vitality
Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months
Secondary Outcome Measures
Radiographic success
Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:
No periapical pathosis.
No radicular resorption defects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05970536
Brief Title
Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
Official Title
The Effect of Two Different Contemporary Chelating Agents on Vital Pulp Therapy in Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sinai University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vital Pulp Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel double blinded.
Masking
ParticipantOutcomes Assessor
Masking Description
double ( participant, outcome assessor)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Apple vinegar group
Arm Type
Experimental
Arm Description
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.
Arm Title
EDTA 17% group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Apple vinegar or EDTA 17%
Intervention Description
Application of each chelating agent for 5 minutes for dentin conditioning followed by placement of MTA on the pulp chamber.
Primary Outcome Measure Information:
Title
Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.
Description
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).
Time Frame
one year
Title
The Pulp vitality
Description
Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months
Time Frame
one year
Secondary Outcome Measure Information:
Title
Radiographic success
Description
Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:
No periapical pathosis.
No radicular resorption defects.
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mona R Abo El Wafa Ahmed, PhD
Organizational Affiliation
Faculty of Dentistry, Sinai University.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mona Rizk Abo El Wafa Ahmed
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
2 years
Learn more about this trial
Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
We'll reach out to this number within 24 hrs