Adult Pulpotomy Success in Diabetic Patientscontrolled cliNCT07332026
Evaluation of the Effect of Type 2 Diabetes Mellitus on the Success of Adult Pulpotomy
A study testing pulpotomy in people with Adult Pulpotomy Success in Diabetic Patients, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The aim of the present study will be directed to evaluate the clinical and radiographic success of adult pulpotomies in type 2 diabetic and non-diabetic patients. Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult Pulpotomy Success in Diabetic Patients
- What is being tested?
- pulpotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 31 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
lower first or second molar diagnosed with irreversible pulpitis in diabetic and non-diabetic patients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the present study will be directed to evaluate the clinical and radiographic success of adult pulpotomies in type 2 diabetic and non-diabetic patients.
Read the detailed description
Out of one hundred patients, Seventy Patients were selected from the outpatient clinic at the faculty of dental medicine Al-Azhar University to take part in this study. Diabetic and non diabetic patients aged between 30 and 65 years complaining of irreversible pulpitis related to the lower permanent first or second molar tooth . All patients were clinically reexamined and radiographically assessed using a periapical radiograph.
- Being tested
- pulpotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulpotomyProcedure or surgery
complete excision of coronal pulp
pulpotomyProcedure or surgery
excision of coronal pulp
| Study group | Role | What they receive |
|---|---|---|
| diabetic | Experimental | type 2 diabetic patients Receives: Procedure: pulpotomy |
| non-diabetic | Experimental | healthy patients Receives: Procedure: pulpotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcome assessment
Assessment of outcome was done using the technique described by Zanini et al. Each patient was evaluated at different time intervals;
Treatment was considered successful if there was an intact final restoration, an asymptomatic tooth, and the periapical index score was 1.
Treatment was considered Uncertain if the final restoration is intact, asymptomatic tooth, and the periapical index score of 2.
Treatment was considered a failure if there was not an intact final restoration, irrelevant clinical symptoms and an irrelevant periapical index score.
Treatment was considered a failure if there was an intact final restoration with symptoms and an irrelevant periapical index score.
- Treatment was considered a failure if there was an intact final restoration, irrelevant clinical symptoms, and the periapical index was 3 or more.
Measured: 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Pulpotomy Success in Diabetic PatientsStudies 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
- Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Mohamed Sulaiman, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07332026
- Sponsor's protocol ID
- 1/6/2023
- Acronym
- controlled cli
- Status last verified
- Dec 2025
- First submitted
- 13 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Type 2 Diabetes Mellitus on the Success of Adult Pulpotomy
- ClinicalTrials.gov ID
- NCT07332026
- Acronym / sponsor ID
- controlled cli / 1/6/2023
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 12 Jan 2026 (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 aim of the present study will be directed to evaluate the clinical and radiographic success of adult pulpotomies in type 2 diabetic and non-diabetic patients.
Detailed description
Out of one hundred patients, Seventy Patients were selected from the outpatient clinic at the faculty of dental medicine Al-Azhar University to take part in this study. Diabetic and non diabetic patients aged between 30 and 65 years complaining of irreversible pulpitis related to the lower permanent first or second molar tooth . All patients were clinically reexamined and radiographically assessed using a periapical radiograph.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| diabetic | Experimental | Procedure: pulpotomytype 2 diabetic patients |
| non-diabetic | Experimental | Procedure: pulpotomyhealthy patients |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| pulpotomycomplete excision of coronal pulp | Procedure or surgery | diabetic, non-diabetic |
| pulpotomyexcision of coronal pulp | Procedure or surgery | diabetic, non-diabetic |
Primary outcome
Outcome assessment
Time frame: 3, 6, 12 months
Assessment of outcome was done using the technique described by Zanini et al. Each patient was evaluated at different time intervals; Treatment was considered successful if there was an intact final restoration, an asymptomatic tooth, and the periapical index score was 1. Treatment was considered Uncertain if the final restoration is intact, asymptomatic tooth, and the periapical index score of 2. Treatment was considered a failure if there was not an intact final restoration, irrelevant clinical symptoms and an irrelevant periapical index score. Treatment was considered a failure if there was an intact final restoration with symptoms and an irrelevant periapical index score. * Treatment was considered a failure if there was an intact final restoration, irrelevant clinical symptoms, and the periapical index was 3 or more.
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 12 Jan 2026.
- Individual participant dataSharing planned: Undecided
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 in people with Adult Pulpotomy Success in Diabetic Patients, 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?
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 12 Jan 2026. 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?
Outcome assessment (time frame: 3, 6, 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 12 Jan 2026.