Reversible PulpitisPulp TherapyNCT07261761
Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy
A study testing Vital pulp therapy, Extraction and blood sample collection in people with Reversible Pulpitis and Irreversible Pulpitis, run by Mansoura University at 1 site in Egypt.
Trial summary
intervention eligible patients with teeth diagnosed with reversible or irreversible pulpits will go for vital pulp therapy and the other group will be patients will go for extraction of caries free teeth for orthodontic reasons, blood samples will be collected from both groups to analyze the level of cytokines IL-8… Read more about this study
- Who is it for?
- Ages 16 to 45 years
- Conditions the study is for
- Reversible Pulpitis, Irreversible Pulpitis
- What is being tested?
- Vital pulp therapy, Extraction and blood sample collection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 2 Apr 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 16 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- The age ranges from 16-45 years medically free.
- Tooth should be vital on cold testing.
- Vital permanent premolar and molar on cold testing, with deep caries, subsequent pulp exposure and bleeding pulp tissue in all canals after complete pulpotomy.
- Diagnosis is either reversible or irreversible pulpitis with/ without periapical rarefaction.
- The tooth is restorable and free from advanced periodontal disease.
- Soft tissues around the tooth are normal with no swelling or sinus tract.
Who cannot join
- Patients over 45 years of age.
- Patients with clinical symptoms of periradicular inflammation or any periradicular radiographic lesions.
- Negative results for cold and electrical pulp testing
Trial locations and contacts
1 site in 1 country.
About this study
intervention eligible patients with teeth diagnosed with reversible or irreversible pulpits will go for vital pulp therapy and the other group will be patients will go for extraction of caries free teeth for orthodontic reasons, blood samples will be collected from both groups to analyze the level of cytokines IL-8 and IL-10 and it's relation with the success of the pulp therapy
- Conditions
- Reversible Pulpitis, Irreversible Pulpitis
- Being tested
- Vital pulp therapy, Extraction, blood sample collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital pulp therapyProcedure or surgery
- Full medical and dental history will be taken from each patient.
- Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth.
- After anesthesia, Rubber dam is applied and complete caries removal will be done, deeply inside the cavity, the excavation will be done using low speed hand piece and excavator.
- A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test.
- After exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) pulp vitality was confirmed by the presence of bleeding pulp tissue from all canals.
- Putty MTA will gently place over the pulp.
- The cavity will be sealed with initial deep layer of resin modified glass ionomer restoration (RMGI) and final superficial layer of composite restoration.
ExtractionProcedure or surgery
- Full medical and dental history will be taken from each patient.
- Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth.
- After anesthesia, Rubber dam is applied.
- A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test.
- Extraction for orthodontic reasons.
blood sample collectionProcedure or surgery
after access opening blood sample will be collected
| Study group | Role | What they receive |
|---|---|---|
| Molars or premolars with Reversible or irreversible pulpits | Experimental | fifteen patients with carious teeth showing signs and symptoms of pulp inflammation Receives: Procedure: Vital pulp therapy; Procedure: blood sample collection |
| Caries free molars or premolars | Active comparator | fifteen patients with intact human premolars planed for extraction for orthodontic reason Receives: Procedure: Extraction; Procedure: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
post operative pain on cold testing binary outcome (Yes or no)
Measured: one day, one, four and twelve weeks.
Secondary outcomes (2)
Radiographic success
Cone Beam Computed Tomography CBCT radiographic Examination for any periodontal widening or any periapical radiolucency.
Measured: Pre-operative , and after six months
level of cytokines
level of Interleukin 8 and Interleukin 10 will be measured using Enzyme- Linked Immunosorbent assay (ELISA) Kit
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Oct 2022
- Primary completion1 Oct 2024
- Study completion2 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Khalifa, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261761
- Sponsor's protocol ID
- M05060722
- Acronym
- Pulp Therapy
- Status last verified
- Jul 2022
- First submitted
- 19 Nov 2025
- Last updated
- 3 Dec 2025
- 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 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokines as Diagnostic Markers of Pulpal Inflammation and Their Impact on the Outcome of Vital Pulp Therapy
- ClinicalTrials.gov ID
- NCT07261761
- Acronym / sponsor ID
- Pulp Therapy / M05060722
- Conditions
- Reversible Pulpitis, Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 2 Apr 2025 (actual)
- First posted
- 3 Dec 2025 (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.
intervention eligible patients with teeth diagnosed with reversible or irreversible pulpits will go for vital pulp therapy and the other group will be patients will go for extraction of caries free teeth for orthodontic reasons, blood samples will be collected from both groups to analyze the level of cytokines IL-8 and IL-10 and it's relation with the success of the pulp therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Molars or premolars with Reversible or irreversible pulpits | Experimental | Procedure: Vital pulp therapy, Procedure: blood sample collectionfifteen patients with carious teeth showing signs and symptoms of pulp inflammation |
| Caries free molars or premolars | Active comparator | Procedure: Extraction, Procedure: blood sample collectionfifteen patients with intact human premolars planed for extraction for orthodontic reason |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- The age ranges from 16-45 years medically free.
- Tooth should be vital on cold testing.
- Vital permanent premolar and molar on cold testing, with deep caries, subsequent pulp exposure and bleeding pulp tissue in all canals after complete pulpotomy.
- Diagnosis is either reversible or irreversible pulpitis with/ without periapical rarefaction.
- The tooth is restorable and free from advanced periodontal disease.
Key exclusion criteria (3 listed)
- Patients over 45 years of age.
- Patients with clinical symptoms of periradicular inflammation or any periradicular radiographic lesions.
- Negative results for cold and electrical pulp testing
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 |
|---|---|---|
| Vital pulp therapy1. Full medical and dental history will be taken from each patient. 2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth. 3. After anesthesia, Rubber dam is applied and complete caries removal will be done, deeply inside the cavity, the excavation will be done using low speed hand piece and excavator. 4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test. 5. After exposure, the pulp will be amputated to the level of the canal orifices (full pulpotomy) pulp vitality was confirmed by the presence of bleeding pulp tissue from all canals. 6. Putty MTA will gently place over the pulp. 7. The cavity will be sealed with initial deep layer of resin modified glass ionomer restoration (RMGI) and final superficial layer of composite restoration. | Procedure or surgery | Molars or premolars with Reversible or irreversible pulpits |
| Extraction1. Full medical and dental history will be taken from each patient. 2. Clinical and radiographic examination (Cone beam computed tomography) for the offending tooth. 3. After anesthesia, Rubber dam is applied. 4. A blood sample will be taken from the bleeding pulp tissue on a cotton pellet for Molecular test. 5. Extraction for orthodontic reasons. | Procedure or surgery | Caries free molars or premolars |
| blood sample collectionafter access opening blood sample will be collected | Procedure or surgery | Caries free molars or premolars, Molars or premolars with Reversible or irreversible pulpits |
Primary outcome
Clinical success
Time frame: one day, one, four and twelve weeks.
post operative pain on cold testing binary outcome (Yes or no)
2 secondary outcomes
Radiographic success
Time frame: Pre-operative , and after six months
level of cytokines
Time frame: through study completion, an average of 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 3 Dec 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Reversible Pulpitis
Not yet recruiting
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
Reversible Pulpitis, Dental Caries
Recruiting
Pomegranate Peel Extract for Primary Molar Pulpotomy
Pulpitis Reversible, Pulp Exposure, Dental
Recruiting
Pelargonium Graveolens Essential Oil as a Pulpotomy Agent in Primary Teeth
Pulpitis - Reversible, Pulpotomies on Primary Molars
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
Recruiting
Comparative Evaluation of Direct Pulp Capping Between Deep and Extremely Deep Caries in Mature Permanent Mandibular Molars .
Reversible Pulpitis, Deep Caries
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 Vital pulp therapy, Extraction and blood sample collection in people with Reversible Pulpitis and Irreversible Pulpitis, run by Mansoura 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 6 inclusion and 3 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 3 Dec 2025. 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?
Clinical success (time frame: one day, one, four and twelve 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 3 Dec 2025.