Pulpitis - ReversibleNCT07171229
Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay
A study testing Pulpotomy and Measuring Cytokines level in people with Pulpitis - Reversible and Occlusal Caries, run by Cairo University at 1 site in Egypt.
Trial summary
pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Pulpitis - Reversible, Occlusal Caries, Proximal Caries
- What is being tested?
- Pulpotomy and Measuring Cytokines level
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with provoked pain.
- Caries in proximal surface to the dentine full thickness.
- Caries in occlusal surface to the dentine full thickness.
- Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
Who cannot join
- Unrestorable primary molars.
- Primary molars with spontaneous pain.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
- Children whose parents are unwilling to place stainless steel crowns.
- Children whose parents or caregivers refuse to participate in the study or are unable to attend follow-up visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay: Non-Randomized Clinical Trial
pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels
Read the detailed description
The proposed trial interventions, pulpotomy, will follow standard clinical procedural guidelines. Participants will be allocated to one of the two intervention groups only after intra-operative confirmation of pulp vitality and achievement of radicular pulp hemostasis.
Standard clinical protocol for both groups with occlusal and proximal decay:
- A detailed history of symptoms will be obtained, and a thorough clinical examination will be conducted.
- Pre-operative pain intensity will be assessed using a validated five-face visual analog scale (VAS), where children select the face that best represents their pain level.
- A standard pre-operative periapical radiograph will be taken, ensuring the image extends beyond the root tip and shows no distortion or processing errors.
- Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
- To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
- Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. to obtain pulpal blood samples. The specimens will be collected into heparin-coated tubes with 1 mg saline solution and stored at - 20 °C (-4.0 °F) for 6 months until the day of testing.
- A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation. Intra-operative assessment of pulp vitality will be conducted, with healthy vital pulp appearing as uniformly reddish-pink vascular tissue and non-vital pulp as dark avascular tissue or yellowish liquefied areas. If necrotic, the tooth will be excluded from the study, and local management protocols will be followed for treatment (Bas et al., 2024).
- MTA will be used as medicament of choice for pulpotomy.
- Once a 2-3 mm thickness is ensured, the cavity will be filled with restorative glass ionomer cement to seal it.
- The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.
- Conditions
- Pulpitis - Reversible, Occlusal Caries, Proximal Caries
- Being tested
- Pulpotomy, Measuring Cytokines level
- Keywords
- pulpotomy, cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
- Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
- To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
- Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s.
- A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation
- MTA will be used as medicament of choice for pulpotomy.
- The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.
Measuring Cytokines levelOther
measuring cytokines level as an indicator for pulp inflammation
| Study group | Role | What they receive |
|---|---|---|
| occlusal decay | Experimental | Primary molars diagnosed with reversible pulpits caused by occlusal decay Receives: Procedure: Pulpotomy; Other: Measuring Cytokines level |
| Proximal decay | Active comparator | Primary molars diagnosed with reversible pulpits caused by Proximal decay. Receives: Procedure: Pulpotomy; Other: Measuring Cytokines level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative Pain
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').
Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Measured: pain will be measured at one week , 3 months , 6 months and 12 months.
Preapical lesion
by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent )
Measured: will be measured at 3 months , 6 months and 12 months
Pain on percussion
Tapping the tooth with the blunt end of the mirror binary outcome: present or absent
Measured: will be measured at 3 months , 6 months and 12 months
Mobility
using Miller's mobility test :involves holding the tooth firmly between two instruments and assessing its mobility on a scale from 0 to 3. A score of 0 indicates no detectable movement, while scores of 1-3 represent increasing degrees of mobility.
it will be measured as present for any score from 1 to 3 (binary: present or absent)
Measured: will be measured at 3 months , 6 months and 12 months
Secondary outcomes (2)
radiographic success
using Digital periapical intraoral radiograph
Radiographic Success:
- Radiolucency at the furcation or periapical area, internal or external root resorption, will be examined (present or not) through digital periapical radiographs.
Criteria for radiographic success
- No evidence of extensive pathologic root resorption.
- No evidence of pathological interradicular and/or periapical radiolucency.
- No evidence of the development of pathologic radiolucency involving the successor tooth germ.
Measured: baseline data at the first visit following the procedure completion and at 6 and 12 months
Cytokines level
blood sample will be collected from exposed pulp chamber before removal and IL-8 \& IL-10 levels will be measured using Enzyme-linked immunoassay ( ELISA) kit. unit of measurement: ng/L
Measured: at the time of pulpotomy procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulpitis - ReversibleStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasmin Khalifa, Cairo University
- Investigators
- Hany Saber, Study chair, Professor of Pediatric Dentistry, Faculty of dentistry, Cairo UniveristyMaii Mohammed, Study director, lecturer of Pediatric Dentistry, Faculty of dentistry, Cairo UniveristyYasmin Magdi Khalifa, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171229
- Sponsor's protocol ID
- 14422023529314
- Status last verified
- Sep 2025
- First submitted
- 25 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cytokines Level as an Indicator of Pulp Inflammation and Its Relation to the Success Rates of Pulpotomy in Primary Molars Affected With Proximal Versus Occlusal Decay: Non-Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07171229
- Acronym / sponsor ID
- 14422023529314
- Conditions
- Pulpitis - Reversible, Occlusal Caries, Proximal Caries
- Keywords
- pulpotomy, cytokines
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 12 Sep 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.
pulpotomy will be done I primary molars with occlusal or proximal decay and level of cytokines will be measured as an indicator for pulp inflammation levels
Detailed description
The proposed trial interventions, pulpotomy, will follow standard clinical procedural guidelines. Participants will be allocated to one of the two intervention groups only after intra-operative confirmation of pulp vitality and achievement of radicular pulp hemostasis.
Standard clinical protocol for both groups with occlusal and proximal decay:
- A detailed history of symptoms will be obtained, and a thorough clinical examination will be conducted.
- Pre-operative pain intensity will be assessed using a validated five-face visual analog scale (VAS), where children select the face that best represents their pain level.
- A standard pre-operative periapical radiograph will be taken, ensuring the image extends beyond the root tip and shows no distortion or processing errors.
- Local anesthesia will be administered, and the tooth will be isolated with a rubber dam.
- To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof.
- Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. to obtain pulpal blood samples. The specimens will be collected into heparin-coated tubes with 1 mg saline solution and stored at - 20 °C (-4.0 °F) for 6 months until the day of testing.
- A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation. Intra-operative assessment of pulp vitality will be conducted, with healthy vital pulp appearing as uniformly reddish-pink vascular tissue and non-vital pulp as dark avascular tissue or yellowish liquefied areas. If necrotic, the tooth will be excluded from the study, and local management protocols will be followed for treatment (Bas et al., 2024).
- MTA will be used as medicament of choice for pulpotomy.
- Once a 2-3 mm thickness is ensured, the cavity will be filled with restorative glass ionomer cement to seal it.
- The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| occlusal decay | Experimental | Procedure: Pulpotomy, Other: Measuring Cytokines levelPrimary molars diagnosed with reversible pulpits caused by occlusal decay |
| Proximal decay | Active comparator | Procedure: Pulpotomy, Other: Measuring Cytokines levelPrimary molars diagnosed with reversible pulpits caused by Proximal decay. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children with provoked pain.
- Caries in proximal surface to the dentine full thickness.
- Caries in occlusal surface to the dentine full thickness.
- Radicular pulp health is verified by achieving hemostasis within eight minutes of compression using a cotton pellet with 5% sodium hypochlorite.
Key exclusion criteria (6 listed)
- Unrestorable primary molars.
- Primary molars with spontaneous pain.
- Medically compromised patients who have systemic disease.
- Uncooperative children who refuse treatment.
- Children whose parents are unwilling to place stainless steel crowns.
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 |
|---|---|---|
| Pulpotomy* Local anesthesia will be administered, and the tooth will be isolated with a rubber dam. * To minimize further bacterial contamination, carious tissues will be removed progressively, starting from the cavity periphery and then over the pulp chamber roof. * Before managing the pulpal hemorrhage, a sterile cotton pellet will be placed over the pulp tissue for 30-45 s. * A fresh sterile bur will be used to remove all coronal pulp tissue down to the root canal orifices, with copious water irrigation * MTA will be used as medicament of choice for pulpotomy. * The pulpotomy-treated tooth will be prepared to receive a full-coverage stainless steel crown (SSC) after the procedure. | Procedure or surgery | Proximal decay, occlusal decay |
| Measuring Cytokines levelmeasuring cytokines level as an indicator for pulp inflammation | Other | Proximal decay, occlusal decay |
Primary outcome
Post operative Pain
Time frame: pain will be measured at one week , 3 months , 6 months and 12 months.
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line. Use a ruler to measure the distance in centimetres from the 'no pain marker' (or zero) to the current pain mark. This provides a pain intensity score out of 10; for example, 6 out of 10 (or 6/10).
Preapical lesion
Time frame: will be measured at 3 months , 6 months and 12 months
by Clinical examination: presence of Swelling, sinus tract, or fistula: ,(binary outcome: present or absent )
Pain on percussion
Time frame: will be measured at 3 months , 6 months and 12 months
Tapping the tooth with the blunt end of the mirror binary outcome: present or absent
Mobility
Time frame: will be measured at 3 months , 6 months and 12 months
using Miller's mobility test :involves holding the tooth firmly between two instruments and assessing its mobility on a scale from 0 to 3. A score of 0 indicates no detectable movement, while scores of 1-3 represent increasing degrees of mobility. it will be measured as present for any score from 1 to 3 (binary: present or absent)
2 secondary outcomes
radiographic success
Time frame: baseline data at the first visit following the procedure completion and at 6 and 12 months
Cytokines level
Time frame: at the time of pulpotomy procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
Hany Saber study chair
Professor of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy
Maii Mohammed study director
lecturer of Pediatric Dentistry, Faculty of dentistry, Cairo Univeristy
Yasmin Magdi Khalifa principal investigator
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 Measuring Cytokines level in people with Pulpitis - Reversible and Occlusal Caries, 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: opening soon, as of the sponsor's last update on 12 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yasmin Ma Khalifa, PhD Candidate (+201000300634, Ymkhalifa1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post operative Pain (time frame: pain will be measured at one week , 3 months , 6 months and 12 months.). The study lists 4 primary outcomes in all. 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 Sep 2025.