Pulp Exposure, DentalNCT06402032
Clinical and Histological Evaluation of Hesperidin as a Direct Pulp Capping Material
A study testing Hesperidin and Mineral Trioxide Aggregate (MTA) in people with Pulp Exposure, Dental and Dental Pulp Capping, run by Cairo University at 1 site in Egypt.
Trial summary
Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Exposure, Dental, Dental Pulp Capping
- What is being tested?
- Hesperidin and Mineral Trioxide Aggregate (MTA)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2022to 30 Mar 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Good oral hygiene,
- Sound wisdom teeth with closed apices with normal pulp vitality response
- No periodontal disease or periapical lesions on periapical radiograph
- Cooperative patients approving to participate in the study
Who cannot join
- Medically compromised participants
- Evidence of parafunctional habits
- Heavy smokers
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis
- Severe periodontal problems or pathological periapical changes
- Teeth with open apex or pulp calcification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical and Histological Evaluation of Hesperidin Versus Mineral Trioxide Aggregate (MTA) as a Direct Pulp Capping Material: A Randomized Controlled Trial
Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Successful pulp capping is the usual way to preserve the vitality of tooth and avoid root canal treatment or surgical tooth extraction.
- Conditions
- Pulp Exposure, Dental, Dental Pulp Capping
- Being tested
- Hesperidin, Mineral Trioxide Aggregate (MTA)
- Medical subject headings
- Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HesperidinOther
Hesperidin is a natural flavonoid with well-known of its anti-inflammatory properties in many disease. Hesperidin in previous studies has been documented to reduce inflammation as well as pain through suppression of cytokine production, NF-κB activity, and oxidative stress. Hesperidin, as a natural product, have been considered as a promising pulp capping material in several invitro and animal studies. However, the regenerative effect of hesperidin as pulp capping material in human teeth has not yet been reported.
Mineral Trioxide Aggregate (MTA)Other
Mineral trioxide aggregate is a cementitious material having various advantages as it is biocompatible, bioactive, osteo-inductive, non-resorbable material with exciting clinical applications, stimulating reparative continuous dentin formation along with maintaining the integrity of the pulp. Moreover, mineral trioxide aggregate provides seal to tooth structure and is of high strength. It is considered the gold standard material for direct pulp capping.
| Study group | Role | What they receive |
|---|---|---|
| Hesperidin | Experimental | Not described Receives: Other: Hesperidin |
| Mineral trioxide aggregate (MTA) | Active comparator | Not described Receives: Other: Mineral Trioxide Aggregate (MTA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate (Clinical evaluation)
Teeth with vital pulp (numerical values with electric pulp tester) and absence of clinical signs/symptoms (Visual Analog Score for pain) as one reported value indicating clinical success rate (%)
Measured: after 12 weeks
Secondary outcomes (2)
Histomorphometric analysis (Histologic evaluation)
Thickness of formed dentin bridge (μm)
Measured: after 12 weeks
Histomorphometric analysis (Histologic evaluation)
Number of inflammatory cells in pulp (scores for Inflammation intensity/extensity)
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 Sep 2022
- Primary completion1 Dec 2023
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Exposure, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Kamal Eldin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402032
- Sponsor's protocol ID
- Hesperidin_MTA
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Histological Evaluation of Hesperidin Versus Mineral Trioxide Aggregate (MTA) as a Direct Pulp Capping Material: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06402032
- Acronym / sponsor ID
- Hesperidin_MTA
- Conditions
- Pulp Exposure, Dental, Dental Pulp Capping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 7 May 2024 (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.
Direct pulp capping technique is one of the oldest known treatments for exposed pulp tissue, and there is a continuous requirement for the most efficient materials to be used in this approach. Successful pulp capping is the usual way to preserve the vitality of tooth and avoid root canal treatment or surgical tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hesperidin | Experimental | Other: Hesperidin |
| Mineral trioxide aggregate (MTA) | Active comparator | Other: Mineral Trioxide Aggregate (MTA) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Good oral hygiene,
- Sound wisdom teeth with closed apices with normal pulp vitality response
- No periodontal disease or periapical lesions on periapical radiograph
- Cooperative patients approving to participate in the study
Key exclusion criteria (6 listed)
- Medically compromised participants
- Evidence of parafunctional habits
- Heavy smokers
- Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis
- Severe periodontal problems or pathological periapical changes
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 |
|---|---|---|
| HesperidinHesperidin is a natural flavonoid with well-known of its anti-inflammatory properties in many disease. Hesperidin in previous studies has been documented to reduce inflammation as well as pain through suppression of cytokine production, NF-κB activity, and oxidative stress. Hesperidin, as a natural product, have been considered as a promising pulp capping material in several invitro and animal studies. However, the regenerative effect of hesperidin as pulp capping material in human teeth has not yet been reported. | Other | Hesperidin |
| Mineral Trioxide Aggregate (MTA)Mineral trioxide aggregate is a cementitious material having various advantages as it is biocompatible, bioactive, osteo-inductive, non-resorbable material with exciting clinical applications, stimulating reparative continuous dentin formation along with maintaining the integrity of the pulp. Moreover, mineral trioxide aggregate provides seal to tooth structure and is of high strength. It is considered the gold standard material for direct pulp capping. | Other | Mineral trioxide aggregate (MTA) |
Primary outcome
Success Rate (Clinical evaluation)
Time frame: after 12 weeks
Teeth with vital pulp (numerical values with electric pulp tester) and absence of clinical signs/symptoms (Visual Analog Score for pain) as one reported value indicating clinical success rate (%)
2 secondary outcomes
Histomorphometric analysis (Histologic evaluation)
Time frame: after 12 weeks
Histomorphometric analysis (Histologic evaluation)
Time frame: after 12 weeks
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 7 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hesperidin and Mineral Trioxide Aggregate (MTA) in people with Pulp Exposure, Dental and Dental Pulp Capping, run by Cairo 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 4 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 7 May 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 (Clinical evaluation) (time frame: after 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 May 2024.