Deep CariesPhase 2NCT06293521
Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries
A Phase 2 study testing Pulpotomy and Partial Pulpectomy in people with Deep Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Caries
- What is being tested?
- Pulpotomy and Partial Pulpectomy
- 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 Dec 2026to 1 Apr 2027
- Phase
- Phase 2
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged 4 to 6 years , in good general health
- The parents provided written informed consent.
- Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.
- Restorable teeth.
Who cannot join
- Physical or mental disability.
- Unable to attend follow-up visits.
- Previously accessed teeth.
- Swelling, tenderness to percussion or palpation, or pathological mobility.
- Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.
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: Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial
This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits
Read the detailed description
Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.
- Conditions
- Deep Caries
- Being tested
- Pulpotomy, Partial Pulpectomy
- Keywords
- Irreversible pulpits, Pulpotomy, Pulpectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PulpotomyProcedure or surgery
After the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement.
Partial PulpectomyProcedure or surgery
Pulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol.
The tooth with then be restored with stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| MTA Pulpotomy | Experimental | Intervention group Receives: Procedure: Pulpotomy |
| Chlorohexidine Pulpectomy | Active comparator | Control group Receives: Procedure: Partial Pulpectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic assessment
Absence of periapical radiolucency or absence of internal/ external root resorption
Measured: Month 6 , Month 12
Secondary outcomes (3)
Clinical effectiveness
absence of any complication or complementary treatment: Absence of spontaneous pain \& Absence of swelling.
Measured: Month 3,Month 6,Month 9,Month 12
Child cooperation
Modified frankl scale ,Categorical rating (rating 1 is definitly negative
- Rating 5 is definitely positive )
Measured: Day 0
Time elapsed till final restoration performed
Stopwatch , measured in minutes
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Dec 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep CariesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mohamed Hassan Mostafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293521
- Sponsor's protocol ID
- 06091995
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Success Rate of Pulpotomy Versus Pulpectomy for Management of Primary Teeth With Deep Caries: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06293521
- Acronym / sponsor ID
- 06091995
- Conditions
- Deep Caries
- Keywords
- Irreversible pulpits, Pulpotomy, Pulpectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Mar 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.
This trial aims to compare treatment outcomes between Pulpotomy and Pulpectomy in treating vital primary teeth diagnosed with deep caries with symptoms of irreversible pulpits
Detailed description
Background: Pulpectomy is the reference treatment for vital primary molars with irreversible pulpitis.Over the past decades, dental caries has unfailingly been the most common chronic infectious disease of childhood and adults. If remained untreated, it can potentially compromise dental pulp tissue. When the dental pulp of primary teeth is irreversibly inflamed, the first treatment choice is pulpectomy, owing to the well-recognized importance of primary tooth retention for child oral/general health. Although a pulpless tooth can remain functional in the oral cavity, modern pediatric endodontics encourages regenerative approaches in primary teeth.The introduction of calcium silicate-based (CS-B) biomaterials such as mineral trioxide aggregate (MTA), along with further understanding of pulp biology and inflammatory processes, has revolutionized treatment modalities for management of irreversible pulpitis in mature permanent teeth. A growing body of evidence has revealed successful implementation of minimally invasive endodontics, that is, vital pulp therapies (VPTs) for management of permanent teeth with irreversible pulpitis even when associated with apical periodontitis. Due to the traditional notion of poorer healing capacity of primary dental pulp, such a paradigm shift has not been seen in pediatric dentistry.Recent research revealed similar vascular/immune responses of primary and permanent dental pulps to caries; therefore, indicating that their healing potential might be this in mind, a reevaluation of traditional approaches for treatment of inflamed primary pulp seems justified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MTA Pulpotomy | Experimental | Procedure: PulpotomyIntervention group |
| Chlorohexidine Pulpectomy | Active comparator | Procedure: Partial PulpectomyControl group |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Aged 4 to 6 years , in good general health
- The parents provided written informed consent.
- Clinical characteristics, defined as spontaneous pain and the presence of a deep carious lesion with pulp exposure and bleeding that did not halt within five minutes following removal of the coronal pulp tissue.
- Restorable teeth.
Key exclusion criteria (5 listed)
- Physical or mental disability.
- Unable to attend follow-up visits.
- Previously accessed teeth.
- Swelling, tenderness to percussion or palpation, or pathological mobility.
- Pre-operative radiographic pathology such as resorption (internal or external), per-radicular or furcation radiolucency.
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 |
|---|---|---|
| PulpotomyAfter the chamber is deroofed and coronal pulp is amputated using a round-end fissure bur in a high-speed handpiece with adequate water spray and light pressure until canal orifices were reached, The access cavity is flushed with sterile normal saline solution. Saline-wetted cotton pellets were placed for about 5 minutes over amputation sites applying moderate pressure to control pulpal hemorrhage. After discarding the pellets, blood oozing was present, MTA+ Cerkamed will be manipulated in the ratio of 3:1 (powder: liquid) to obtain a putty mix. This mix will be placed over the radicular pulp with the help of a suitable sterile amalgam carrier. Gentle condensation of the mix will be done in the pulp chamber with a moistened cotton pellet, followed by application of glass ionomer cement. | Procedure or surgery | MTA Pulpotomy |
| Partial PulpectomyPulp tissue extirpation is done. Biomechanical preparation is done using rotary files with frequent irrigation with Chlorhexidine. The canals are dried using sterile absorbent paper points followed by obturation by the paste of Zinc oxide and eugenol. The tooth with then be restored with stainless steel crown | Procedure or surgery | Chlorohexidine Pulpectomy |
Primary outcome
Radiographic assessment
Time frame: Month 6 , Month 12
Absence of periapical radiolucency or absence of internal/ external root resorption
3 secondary outcomes
Clinical effectiveness
Time frame: Month 3,Month 6,Month 9,Month 12
Child cooperation
Time frame: Day 0
Time elapsed till final restoration performed
Time frame: Day 0
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 23 Sep 2026.
Related trials for Deep Caries
Recruiting
"The Relationship Between Pulpal Inflammatory Marker Levels in Moderate and Severe Pulpitis and Outcome of Full Pulpotomy in Mandibular Molars With Extremely Deep Caries: A Prospective Cohort Study."
Moderate Severe Pulpitis, Extremely Deep Caries
Recruiting
Outcome of Partial Pulpotomy in Permanent Mandibular Molars With Symptomatic Irreversible Pulpitis After Wound Lavage With Calcium Hypochlorite or Sodium Hypochlorite
Symptomatic Irreversible Pulpitis (SIP), Extremely Deep Caries
Active, not recruiting
Outcome of Selective Caries Removal Performed by Undergraduate Students
Deep Caries Lesion of Pemanent Teeth
Enrolling by invitation
Evaluation of Selective and Stepwise Excavation in Young Permanent Teeth With Deep Caries Lesions.
Dental Caries, Dental Cavities
Active, not recruiting
Pulp Inflammatory Markers and Outcome of Pulpotomy
Pulpitis in Permanent Teeth, Dental Caries Extending to Pulp
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pulpotomy and Partial Pulpectomy in people with Deep 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 5 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: looking for participants now, as of the sponsor's last update on 23 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nada Mostafa, B.D.S (01117311533, Nadamostafa@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic assessment (time frame: Month 6 , Month 12). 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 23 Sep 2026.