Irreversible PulpitisNCT06231290
The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth
A study testing Adult full pulpotomy procedure in people with Irreversible Pulpitis, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Adult full pulpotomy procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2024to Jul 2025
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.
Who cannot join
- Non-vital teeth.
- Immature teeth.
- Presence of swelling or sinus tract.
- Teeth with mobility grade II or III.
- Immunocompromised patients.
- Non-restorable teeth.
Show all 11Show fewer
- Teeth with apical periodontitis seen in periapical radiograph.
- Periodontally affected teeth.
- Teeth with reversible pulpitis
- Extensive non-stoppable bleeding more than 6 minutes
- Teeth with partial necrosis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dental Medicine, Al-Azhar University
Cairo, 11751
Moataz A Alkhawas, Professor, +201001189085, moataz-bellahalkhawas.209@azhar.edu.eg
About this study
Official title: The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth: A Randomized Clinical Trial
The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth.
The main questions it aims to answer are:
Read more
- Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?
- Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars?
Participants will be asked to do the following:
- Receive the pulpotomy treatment of their target molar tooth.
- Record the pain score in the pain assessment chart.
- Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy.
- Conditions
- Irreversible Pulpitis
- Being tested
- Adult full pulpotomy procedure
- Keywords
- Pulpotomy, Magnification, Clinical experience, Irreversible pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adult full pulpotomy procedureOther
The adult pulpotomy procedure of mature molars will be carried out with the use of magnification (dental loupes or microscope) in healthy patients. The procedure will be performed either by postgraduate or undergraduate operators.
| Study group | Role | What they receive |
|---|---|---|
| Postgraduate operator with magnification | Active comparator | Not described Receives: Other: Adult full pulpotomy procedure |
| Postgraduate operator without magnification | Experimental | Not described Receives: Other: Adult full pulpotomy procedure |
| Undergraduate operator with magnification | Experimental | Not described Receives: Other: Adult full pulpotomy procedure |
| Undergraduate operator without magnification | Experimental | Not described Receives: Other: Adult full pulpotomy procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical and radiographic outcome
The clinical outcome will be measured by the presence or absence of signs and symptoms. The radiographic outcome will be measured by using the PAI index which is a scale from 1 (best) to 5 (worst).
Measured: Immediately, 1, 3, 6 and 12 months.
Secondary outcomes (1)
Postoperative pain
The postoperative pain will be measured by the modified Verbal Descriptor Scale which is a scale from 0 (best) to 10 (worst).
Measured: Immediately, 24, 48, 72 hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start20 Mar 2024
- Primary completionApr 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Mohamed Yahia, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231290
- Sponsor's protocol ID
- 874/3036
- Status last verified
- May 2024
- First submitted
- 20 Jan 2024
- Last updated
- 14 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 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Magnification and Clinical Experience on the Outcome of Pulpotomy in Mature Adult Teeth: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06231290
- Acronym / sponsor ID
- 874/3036
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpotomy, Magnification, Clinical experience, Irreversible pulpitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 30 Jan 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.
The goal of this interventional randomized clinical trial is to test the effect of magnification and clinical experience of the operator on the success rate of full pulpotomy in mature adult molar teeth.
The main questions it aims to answer are:
- Does the use of magnification raise the success rate of full pulpotomy of mature adult molars?
- Does the clinical experience of the operator dentist raise the success rate of full pulpotomy of mature adult molars?
Participants will be asked to do the following:
- Receive the pulpotomy treatment of their target molar tooth.
- Record the pain score in the pain assessment chart.
- Attend the follow-up visits. They'll receive a full pulpotomy treatment of their target molar tooth. Researchers will evaluate the usage of magnification in performing the pulpotomy procedure of adult molar teeth by postgraduate or undergraduate operators in comparison to performing the same pulpotomy procedure without magnification to see if it raises the overall success rate of pulpotomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Postgraduate operator with magnification | Active comparator | Other: Adult full pulpotomy procedure |
| Postgraduate operator without magnification | Experimental | Other: Adult full pulpotomy procedure |
| Undergraduate operator with magnification | Experimental | Other: Adult full pulpotomy procedure |
| Undergraduate operator without magnification | Experimental | Other: Adult full pulpotomy procedure |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy patients diagnosed with acute irreversible pulpitis related to maxillary or mandibular permanent molar teeth without apical periodontitis.
Key exclusion criteria (11 listed)
- Non-vital teeth.
- Immature teeth.
- Presence of swelling or sinus tract.
- Teeth with mobility grade II or III.
- Immunocompromised patients.
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 |
|---|---|---|
| Adult full pulpotomy procedureThe adult pulpotomy procedure of mature molars will be carried out with the use of magnification (dental loupes or microscope) in healthy patients. The procedure will be performed either by postgraduate or undergraduate operators. | Other | Postgraduate operator with magnification, Postgraduate operator without magnification, Undergraduate operator with magnification, Undergraduate operator without magnification |
Primary outcome
Clinical and radiographic outcome
Time frame: Immediately, 1, 3, 6 and 12 months.
The clinical outcome will be measured by the presence or absence of signs and symptoms. The radiographic outcome will be measured by using the PAI index which is a scale from 1 (best) to 5 (worst).
1 secondary outcome
Postoperative pain
Time frame: Immediately, 24, 48, 72 hours and 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adult full pulpotomy procedure in people with Irreversible Pulpitis, 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 11 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: status not confirmed, as of the sponsor's last update on 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed A. Yahia, BSc (+201273892231, mohamed.de2016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical and radiographic outcome (time frame: Immediately, 1, 3, 6 and 12 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 14 May 2024.