Vital Pulp TherapyNCT05970536
Vital Pulp Therapy of Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
A study testing Apple vinegar or EDTA 17% in people with Vital Pulp Therapy, run by Sinai University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Pulp Therapy
- What is being tested?
- Apple vinegar or EDTA 17%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vital Pulp Therapy
- Being tested
- Apple vinegar or EDTA 17%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Apple vinegar or EDTA 17% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one year
The Pulp vitality
Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months
Measured: one year
Secondary outcomes (1)
Radiographic success
Using digital periapical radiograph at 3,6,12 months. Radiographic success criteria include:
- No periapical pathosis.
- No radicular resorption defects.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Dec 2022
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vital Pulp TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel double blinded.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Rizk Abo El Wafa Ahmed, Sinai University
- Investigators
- Mona R Abo El Wafa Ahmed, PhD, Principal investigator, Faculty of Dentistry, Sinai University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970536
- Sponsor's protocol ID
- 341122
- Status last verified
- Jul 2023
- First submitted
- 8 Jul 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 39118082
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Different Contemporary Chelating Agents on Vital Pulp Therapy in Mature Permanent Teeth With Irreversible Pulpitis Using Bioceramic Material
- ClinicalTrials.gov ID
- NCT05970536
- Acronym / sponsor ID
- 341122
- Conditions
- Vital Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel double blinded.
| Arm | Type | Receives |
|---|---|---|
| Apple vinegar group | Experimental | Other: 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 | Active comparator | Other: 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Teeth with pulp necrosis.
- Presence of sinus tract.
- Teeth with open apices.
- Pregnant women.
- History of intolerance of non- steroidal anti inflammatory drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Apple vinegar group, EDTA 17% group |
Primary outcome
Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.
Time frame: 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
Time frame: one year
Pulp vitality will be assessed through pulpal response to thermal and electrical pulp tests. at 3,6,12 months
1 secondary outcome
Radiographic success
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 39118082Sobh 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.
- Individual participant dataSharing planned: Yes
Related trials for Vital Pulp Therapy
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Laser-Assisted vs Conventional Total Pulpotomy in Symptomatic Irreversible Pulpitis
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Prognostic Value of Pulpal Blood pH and Oxygen Saturation in Vital Pulp Therapy: Determination of Clinically Relevant Thresholds in a Prospective Clinical Study
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Clinical Evaluation of Discoloration Induced by Root Canal Treatment in Vital and Devital Teeth
Tooth Discoloration Following Root Canal Treatment, Tooth Discoloration
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mona R Abo El Wafa Ahmed, PhD principal investigator
Faculty of Dentistry, Sinai University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apple vinegar or EDTA 17% in people with Vital Pulp Therapy, run by Sinai University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material. (time frame: one year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05970536, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.