Dental CariesNCT06694064
Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effect on Pulpotomy
A study testing Pulpotomy and extraction for histologic examination in people with Dental Caries, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Read more about this study
- Who is it for?
- Ages 7 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Pulpotomy and extraction for histologic examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Jan 2023to 2 Sep 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 7 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- healthy patients with carious primary molars
Who cannot join
- root resorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effectiveness in Pulpotomy of Primary Molars
Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.
- Conditions
- Dental Caries
- Being tested
- Pulpotomy, extraction for histologic examination
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
Pulpotomy will be done for mta group
extraction for histologic examinationProcedure or surgery
after pulp therapy the teeth exrtracted for histologic examination
| Study group | Role | What they receive |
|---|---|---|
| Mta group | Experimental | after pulpotomy the pulp stumps subgected to mta material Receives: Procedure: Pulpotomy; Procedure: extraction for histologic examination |
| Grape seed group | Experimental | after pulpotomy the pulp stumps subjected to grape seed Receives: Procedure: Pulpotomy; Procedure: extraction for histologic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate pain of the teeth
The lack of any clinical indications of pulp degeneration, such as the history of spontaneous pain, pain on percussion, swelling, pathological mobility, or sinus tract
Measured: 6 months
Secondary outcomes (1)
absence of radiolucency
No signs of periapical orfurcal radiolucency, widening of the periodontal ligament (PDL), or pathological root resorption (internal or external).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start2 Jan 2023
- Primary completion10 Jan 2024
- Study completion2 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sara nabil, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694064
- Sponsor's protocol ID
- REC- PD-23-01
- Status last verified
- Nov 2024
- First submitted
- 21 Oct 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Mineral Trioxide Aggregates and Grape Seeds Extract Effectiveness in Pulpotomy of Primary Molars
- ClinicalTrials.gov ID
- NCT06694064
- Acronym / sponsor ID
- REC- PD-23-01
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 2 Sep 2024 (actual)
- First posted
- 19 Nov 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.
Pediatric dentistry has always debated the benefits of vital pulp therapy. AIM: The current study was done to differentiate the histo-pathological findings of MTA versus grape seed extract in primary teeth undergoing pulpotomy as pulp dressing substances. Materials and Methods: According to the inclusion criteria, 16 primary teeth were selected in each group. Randomly and equally, the teeth were split into two groups: (MTA group) Group I, and (GSE group) Group II. After nine months, under a light microscope the teeth were evaluated and a clinical follow-up was conducted. Periapical radiographs were also taken at this time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mta group | Experimental | Procedure: Pulpotomy, Procedure: extraction for histologic examinationafter pulpotomy the pulp stumps subgected to mta material |
| Grape seed group | Experimental | Procedure: Pulpotomy, Procedure: extraction for histologic examinationafter pulpotomy the pulp stumps subjected to grape seed |
Who may qualify
- Ages
- 7 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- healthy patients with carious primary molars
Key exclusion criteria (1 listed)
- root resorption
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 |
|---|---|---|
| PulpotomyPulpotomy will be done for mta group | Procedure or surgery | Grape seed group, Mta group |
| extraction for histologic examinationafter pulp therapy the teeth exrtracted for histologic examination | Procedure or surgery | Grape seed group, Mta group |
Primary outcome
evaluate pain of the teeth
Time frame: 6 months
The lack of any clinical indications of pulp degeneration, such as the history of spontaneous pain, pain on percussion, swelling, pathological mobility, or sinus tract
1 secondary outcome
absence of radiolucency
Time frame: 6 months
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 19 Nov 2024.
- Individual participant dataSharing planned: No
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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 Pulpotomy and extraction for histologic examination in people with Dental Caries, run by Al-Azhar 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 1 inclusion and 1 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 19 Nov 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?
evaluate pain of the teeth (time frame: 6 months). 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 19 Nov 2024.