Reversible PulpitisCEHA-TP RCTNCT07876934
Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars
A study testing 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%) in people with Reversible Pulpitis and Dental Caries, run by Reem Mohamed Gaber at 1 site in Egypt.
Trial summary
Dental caries in primary teeth can sometimes lead to inflammation of the dental pulp, the soft tissue inside the tooth. When the pulp remains capable of healing, pulpotomy may be performed to preserve the tooth until its natural exfoliation. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Reversible Pulpitis, Dental Caries, Primary Molar Pulpotomy
- What is being tested?
- 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2027to 1 Dec 2027
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 4 to 6 years old.
- Medically healthy children based on medical history taken from parents/guardians.
- Children whose parents agree to comply with follow-up visits.
- Children whose parents/guardians sign the informed consent and children who give assent.
- Carious vital primary lower molars indicated for pulpotomy diagnosed with reversible pulpitis.
- Asymptomatic teeth or teeth displaying provoked pain of short duration.
Who cannot join
- Uncooperative children.
- Medically compromised children.
- Patients whose parents refuse to participate or sign the informed consent. *Children who cannot attend the scheduled follow-up visits.
- Previously accessed molars.
- Uncontrolled pulpal bleeding following coronal pulp amputation.
- Presence of a sinus tract or fistula.
- Presence of pain on percussion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Reem Gaber Mohamed, Principal Investigator / PhD C contact
Manal Ahmed ElSayed Ahmed Study Director / Main Supervisor, Prof. Dr. contact
Egypt1 site
Postgraduate Outpatients Clinic, Pediatric Dentistry Department, Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate, 11553
About this study
Official title: Comparative Evaluation of Different Hemostatic Agents on Clinical and Radiographic Success of TheraCal PT Pulpotomy in Primary Molars With Reversible Pulpitis: A Randomized Controlled Trial
Dental caries in primary teeth can sometimes lead to inflammation of the dental pulp, the soft tissue inside the tooth. When the pulp remains capable of healing, pulpotomy may be performed to preserve the tooth until its natural exfoliation. During this procedure, bleeding from the remaining pulp tissue must be controlled before a pulp dressing material is placed.
This randomized controlled clinical trial aims to compare the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when three different solutions are used to control bleeding: 2.5% sodium hypochlorite, 15% ferric sulfate, and normal saline.
Read more
Children aged 4-6 years who have primary molars diagnosed with reversible pulpitis and meet the study's eligibility criteria will be enrolled. Participants will be randomly assigned to one of three groups according to the hemostatic solution used during the pulpotomy procedure. TheraCal PT will be used as the pulpotomy material in all three groups.
The treated teeth will be evaluated clinically at 3, 6, 9, and 12 months and radiographically at baseline, 6 months, and 12 months. The researchers will compare the outcomes among the three groups to determine whether the choice of hemostatic solution affects the success of TheraCal PT pulpotomy in primary molars.
The findings may help improve understanding of the role of different hemostatic solutions in pulpotomy treatment for primary teeth.
Read the detailed description
Background and Rationale
Pulpotomy is the standard treatment for carious primary molars with reversible pulpitis. It aims to keep the radicular pulp vital until the tooth exfoliates naturally. Success depends on the capping material and on how well pulpal bleeding is controlled before capping. Residual blood clot can interfere with adaptation of the capping material to the pulp tissue. Mineral trioxide aggregate (MTA) is the reference material but is difficult to handle and slow to set. This led to resin-modified calcium silicate materials. TheraCal PT is a dual-cured material designed to improve on its predecessor, TheraCal LC. In vitro studies show good cytocompatibility and bioactivity. Clinical evidence in primary molars is limited, and the available trials report conflicting radiographic results.
Sodium hypochlorite, ferric sulfate and saline are commonly used to control pulpal bleeding. They act in different ways: sodium hypochlorite is antimicrobial and debrides tissue, ferric sulfate causes protein coagulation, and saline acts mainly through mechanical pressure. Because TheraCal PT depends on direct contact with the pulp, the hemostatic agent used beforehand may affect clinical performance. To our knowledge, no published trial has examined this interaction. This trial addresses that gap.
Objective and Hypothesis
The trial compares the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when sodium hypochlorite, ferric sulfate or saline is used as the hemostatic agent. The null hypothesis is that there is no difference in success between the three agents.
Study Design Overview
This is a prospective, single-center, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. It is conducted at the Pediatric Dentistry Department, Cairo University, Egypt. All treatment is performed by one operator (the principal investigator). The outcome assessor and statistician are blinded to group allocation.
Randomization and Allocation Concealment
A computer-generated simple randomization sequence is prepared by an independent research assistant who takes no part in recruitment, treatment or assessment. Allocation is concealed with sequentially numbered, opaque, sealed envelopes. An envelope is opened only after isolation, access cavity preparation and coronal pulp amputation, immediately before the hemostatic agent is applied. This minimizes selection bias.
Procedure Summary
Treatment follows a single standardized protocol under local anesthesia and rubber dam isolation. The only difference between groups is the hemostatic agent. After coronal pulp amputation, hemostasis is attempted with the allocated agent. Teeth in which bleeding cannot be controlled are excluded and treated appropriately. TheraCal PT is then placed (2 mm thick over the pulpal floor) and light-cured. All teeth are restored in the same visit with glass ionomer cement and a stainless-steel crown. Post-operative radiographs are taken with a customized radiographic stent and a paralleling device to standardize follow-up images.
Follow-up and Assessment
Children are followed for 12 months. Clinical examination is at baseline, 3, 6, 9 and 12 months. Radiographic examination is at baseline, 6 and 12 months. Assessments are done independently by blinded assessors, and disagreements are resolved by consensus. Data are recorded on standardized case report forms.
Sample Size
The sample size was calculated in G*Power 3.1.9.2 using a two-tailed Z test for the difference between two independent proportions (alpha 5%, power 80%). The calculation assumed 100% clinical success at 12 months in the saline group (Gani and Öznurhan, 2026) and a 30% difference. This gave a minimum of 22 per group. After a 15% increase for dropouts, the target is 25 per group (75 in total).
Statistical Analysis
Categorical data are summarized as frequencies and percentages. Between-group comparisons use the chi-square test. Within-group changes over time use Cochran's Q test with pairwise comparisons. All tests are two-tailed with significance at p ≤ 0.05, analyzed in MedCalc v22.
Bias Control
Selection bias is addressed by random sequence generation and allocation concealment. Performance bias is addressed by standardizing the procedure across groups. Detection bias is addressed by blinding the outcome assessor. Reporting bias is addressed by prospective registration and by reporting all prespecified outcomes.
- Being tested
- 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)
- Keywords
- TheraCal PT, hemostatic agents, sodium hypochlorite, ferric sulfate, primary molars, vital pulp therapy
- Medical subject headings
- Dental Caries, Dental Pulp Exposure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)Drug
2.5% Sodium Hypochlorite applied to the root canal orifices/pulpal tissue for 3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and 15% Ferric Sulfate (Astringedent™ 15.5%) applied directly against the pulpal tissue/stumps for 1-3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and Sterile 0.9% Normal Saline applied with gentle pressure for 3 minutes using a moistened cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown
| Study group | Role | What they receive |
|---|---|---|
| 2.5% sodium hypochlorite | Experimental | Applied to pulpal tissue for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy. Receives: Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%) |
| 15.5 % ferric sulfate | Experimental | Applied to pulpal tissue for 1 to 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy. Receives: Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%) |
| TheraCal PT pulpotomy with saline (control) | Active comparator | Hemostasis of the pulp stumps is attempted by gentle pressure for three minutes with a sterile cotton pellet moistened with saline, followed by drying with air spray. TheraCal PT is then placed in a 2-mm thickness on the pulpal floor and light-cured for 10 seconds. The tooth is restored with glass ionomer cement and a stainless-steel crown in the same visit Receives: Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Clinical Success Rate
Percentage of teeth demonstrating clinical success, defined as the absence of all of the following clinical signs and symptoms: postoperative pain, spontaneous pain, tenderness to percussion, swelling, sinus tract/fistula, and pathological tooth mobility. Binary assessment (present/absent) evaluated by asking the patient and parent/guardian.
Measured: Assessed at 3, 6, 9, and 12 months postoperatively.
Secondary outcomes (2)
Overall Radiographic Success Rate
Percentage of teeth displaying the absence of all adverse radiographic findings, including periodontal ligament space widening, furcal or periapical bone resorption, and external or internal root resorption. Digital radiographic examination evaluated using DIGORA software (version 2.7 R2)
Measured: Assessed at baseline, 6, and 12 months postoperatively.
Pulp Canal Obliteration (PCO)
Presence and extent of pulp canal calcification, classified as partial or total obliteration according to the Jacobsen \& Sangnes (1978) classification, evaluated via digital radiographic examination
Measured: Assessed at baseline, 6, and 12 months postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Reversible PulpitisStudies of the same condition, open and under way.
- 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
- Model description
- This is a prospective, single-center, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Children with carious vital primary mandibular molars diagnosed with reversible pulpitis are randomly assigned to one of three groups. All three groups receive the same TheraCal PT pulpotomy, and the only difference is the hemostatic agent applied before capping: 2.5% sodium hypochlorite (intervention group 1), 15.5% ferric sulfate (intervention group 2), or saline (control group). Simple randomization uses a computer-generated sequence. Allocation is concealed with sequentially numbered, opaque, sealed envelopes opened only after coronal pulp amputation. Each child is treated once and followed for 12 months. There is no crossover between groups."
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reem Mohamed Gaber
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reem Mohamed Gaber, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876934
- Sponsor's protocol ID
- CU-PEDO-THPT-001.REEMGABER1993
- Acronym
- CEHA-TP RCT
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly in order to protect participant confidentiality and privacy, in accordance with the ethical approval guidelines and data protection procedures of the Faculty of Dentistry, Cairo University.
Publications
Mostafa HMM, Barakat IF, Abbas AN. Clinical and radiographic evaluation of different hemorrhage control agents and base material on pulpotomized primary molars. Al-Azhar Journal of Dental Science. 2024;27(3):435-445.
Elchaghaby MA, Moheb DM, El Shahawy OI, Abd Alsamad AM, Rashed MAM. Clinical and radiographic evaluation of indirect pulp treatment of young permanent molars using photo-activated oral disinfection versus calcium hydroxide: a randomized controlled pilot trial. BDJ Open. 2020 Mar 17;6:4. doi: 10.1038/s41405-020-0030-z. eCollection 2020.
PubMed 32194986Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
PubMed 36890738Moselhy YH, Elghazawy RK, Wassel MO. Clinical and radiographic evaluation of indirect and direct pulp capping in primary molars using TheraCal (LC): a randomized clinical trial. Egyptian Dental Journal. 2022;68(4):3065-3076
Gaber RM, Mhmoud SA, Nagi PN. Clinical and radiographic success rate of TheraCal PT versus MTA in pulpotomy of primary molars: a randomised clinical pilot study. Alexandria Dental Journal. 2024;49(1):162-169.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Different Hemostatic Agents on Clinical and Radiographic Success of TheraCal PT Pulpotomy in Primary Molars With Reversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07876934
- Acronym / sponsor ID
- CEHA-TP RCT / CU-PEDO-THPT-001.REEMGABER1993
- Keywords
- TheraCal PT, hemostatic agents, sodium hypochlorite, ferric sulfate, primary molars, vital pulp therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Reem Mohamed GaberUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 15 Oct 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.
Dental caries in primary teeth can sometimes lead to inflammation of the dental pulp, the soft tissue inside the tooth. When the pulp remains capable of healing, pulpotomy may be performed to preserve the tooth until its natural exfoliation. During this procedure, bleeding from the remaining pulp tissue must be controlled before a pulp dressing material is placed.
This randomized controlled clinical trial aims to compare the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when three different solutions are used to control bleeding: 2.5% sodium hypochlorite, 15% ferric sulfate, and normal saline.
Children aged 4-6 years who have primary molars diagnosed with reversible pulpitis and meet the study's eligibility criteria will be enrolled. Participants will be randomly assigned to one of three groups according to the hemostatic solution used during the pulpotomy procedure. TheraCal PT will be used as the pulpotomy material in all three groups.
The treated teeth will be evaluated clinically at 3, 6, 9, and 12 months and radiographically at baseline, 6 months, and 12 months. The researchers will compare the outcomes among the three groups to determine whether the choice of hemostatic solution affects the success of TheraCal PT pulpotomy in primary molars.
The findings may help improve understanding of the role of different hemostatic solutions in pulpotomy treatment for primary teeth.
Detailed description
Background and Rationale
Pulpotomy is the standard treatment for carious primary molars with reversible pulpitis. It aims to keep the radicular pulp vital until the tooth exfoliates naturally. Success depends on the capping material and on how well pulpal bleeding is controlled before capping. Residual blood clot can interfere with adaptation of the capping material to the pulp tissue. Mineral trioxide aggregate (MTA) is the reference material but is difficult to handle and slow to set. This led to resin-modified calcium silicate materials. TheraCal PT is a dual-cured material designed to improve on its predecessor, TheraCal LC. In vitro studies show good cytocompatibility and bioactivity. Clinical evidence in primary molars is limited, and the available trials report conflicting radiographic results.
Sodium hypochlorite, ferric sulfate and saline are commonly used to control pulpal bleeding. They act in different ways: sodium hypochlorite is antimicrobial and debrides tissue, ferric sulfate causes protein coagulation, and saline acts mainly through mechanical pressure. Because TheraCal PT depends on direct contact with the pulp, the hemostatic agent used beforehand may affect clinical performance. To our knowledge, no published trial has examined this interaction. This trial addresses that gap.
Objective and Hypothesis
The trial compares the clinical and radiographic success of TheraCal PT pulpotomy in primary molars when sodium hypochlorite, ferric sulfate or saline is used as the hemostatic agent. The null hypothesis is that there is no difference in success between the three agents.
Study Design Overview
This is a prospective, single-center, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. It is conducted at the Pediatric Dentistry Department, Cairo University, Egypt. All treatment is performed by one operator (the principal investigator). The outcome assessor and statistician are blinded to group allocation.
Randomization and Allocation Concealment
A computer-generated simple randomization sequence is prepared by an independent research assistant who takes no part in recruitment, treatment or assessment. Allocation is concealed with sequentially numbered, opaque, sealed envelopes. An envelope is opened only after isolation, access cavity preparation and coronal pulp amputation, immediately before the hemostatic agent is applied. This minimizes selection bias.
Procedure Summary
Treatment follows a single standardized protocol under local anesthesia and rubber dam isolation. The only difference between groups is the hemostatic agent. After coronal pulp amputation, hemostasis is attempted with the allocated agent. Teeth in which bleeding cannot be controlled are excluded and treated appropriately. TheraCal PT is then placed (2 mm thick over the pulpal floor) and light-cured. All teeth are restored in the same visit with glass ionomer cement and a stainless-steel crown. Post-operative radiographs are taken with a customized radiographic stent and a paralleling device to standardize follow-up images.
Follow-up and Assessment
Children are followed for 12 months. Clinical examination is at baseline, 3, 6, 9 and 12 months. Radiographic examination is at baseline, 6 and 12 months. Assessments are done independently by blinded assessors, and disagreements are resolved by consensus. Data are recorded on standardized case report forms.
Sample Size
The sample size was calculated in G*Power 3.1.9.2 using a two-tailed Z test for the difference between two independent proportions (alpha 5%, power 80%). The calculation assumed 100% clinical success at 12 months in the saline group (Gani and Öznurhan, 2026) and a 30% difference. This gave a minimum of 22 per group. After a 15% increase for dropouts, the target is 25 per group (75 in total).
Statistical Analysis
Categorical data are summarized as frequencies and percentages. Between-group comparisons use the chi-square test. Within-group changes over time use Cochran's Q test with pairwise comparisons. All tests are two-tailed with significance at p ≤ 0.05, analyzed in MedCalc v22.
Bias Control
Selection bias is addressed by random sequence generation and allocation concealment. Performance bias is addressed by standardizing the procedure across groups. Detection bias is addressed by blinding the outcome assessor. Reporting bias is addressed by prospective registration and by reporting all prespecified outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a prospective, single-center, parallel-group randomized controlled trial with a 1:1:1 allocation ratio. Children with carious vital primary mandibular molars diagnosed with reversible pulpitis are randomly assigned to one of three groups. All three groups receive the same TheraCal PT pulpotomy, and the only difference is the hemostatic agent applied before capping: 2.5% sodium hypochlorite (intervention group 1), 15.5% ferric sulfate (intervention group 2), or saline (control group). Simple randomization uses a computer-generated sequence. Allocation is concealed with sequentially numbered, opaque, sealed envelopes opened only after coronal pulp amputation. Each child is treated once and followed for 12 months. There is no crossover between groups."
| Arm | Type | Receives |
|---|---|---|
| 2.5% sodium hypochlorite | Experimental | Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)Applied to pulpal tissue for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy. |
| 15.5 % ferric sulfate | Experimental | Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)Applied to pulpal tissue for 1 to 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy. |
| TheraCal PT pulpotomy with saline (control) | Active comparator | Drug: 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)Hemostasis of the pulp stumps is attempted by gentle pressure for three minutes with a sterile cotton pellet moistened with saline, followed by drying with air spray. TheraCal PT is then placed in a 2-mm thickness on the pulpal floor and light-cured for 10 seconds. The tooth is restored with glass ionomer cement and a stainless-steel crown in the same visit |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 4 to 6 years old.
- Medically healthy children based on medical history taken from parents/guardians.
- Children whose parents agree to comply with follow-up visits.
- Children whose parents/guardians sign the informed consent and children who give assent.
- Carious vital primary lower molars indicated for pulpotomy diagnosed with reversible pulpitis.
Key exclusion criteria (7 listed)
- Uncooperative children.
- Medically compromised children.
- Patients whose parents refuse to participate or sign the informed consent. *Children who cannot attend the scheduled follow-up visits.
- Previously accessed molars.
- Uncontrolled pulpal bleeding following coronal pulp amputation.
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 |
|---|---|---|
| 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%)2.5% Sodium Hypochlorite applied to the root canal orifices/pulpal tissue for 3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and 15% Ferric Sulfate (Astringedent™ 15.5%) applied directly against the pulpal tissue/stumps for 1-3 minutes using a cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown and Sterile 0.9% Normal Saline applied with gentle pressure for 3 minutes using a moistened cotton pellet to achieve hemostasis prior to application of 2-mm TheraCal PT and final restoration with glass ionomer cement and a stainless steel crown | Drug | 15.5 % ferric sulfate, 2.5% sodium hypochlorite, TheraCal PT pulpotomy with saline (control) |
Primary outcome
Overall Clinical Success Rate
Time frame: Assessed at 3, 6, 9, and 12 months postoperatively.
Percentage of teeth demonstrating clinical success, defined as the absence of all of the following clinical signs and symptoms: postoperative pain, spontaneous pain, tenderness to percussion, swelling, sinus tract/fistula, and pathological tooth mobility. Binary assessment (present/absent) evaluated by asking the patient and parent/guardian.
2 secondary outcomes
Overall Radiographic Success Rate
Time frame: Assessed at baseline, 6, and 12 months postoperatively.
Pulp Canal Obliteration (PCO)
Time frame: Assessed at baseline, 6, and 12 months postoperatively.
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 15 Oct 2026.
- Results publicationMostafa HMM, Barakat IF, Abbas AN. Clinical and radiographic evaluation of different hemorrhage control agents and base material on pulpotomized primary molars. Al-Azhar Journal of Dental Science. 2024;27(3):435-445.
- Results publication: PubMed 32194986Elchaghaby MA, Moheb DM, El Shahawy OI, Abd Alsamad AM, Rashed MAM. Clinical and radiographic evaluation of indirect pulp treatment of young permanent molars using photo-activated oral disinfection versus calcium hydroxide: a randomized controlled pilot trial. BDJ Open. 2020 Mar 17;6:4. doi: 10.1038/s41405-020-0030-z. eCollection 2020.
- Results publication: PubMed 36890738Wassel M, Hamdy D, Elghazawy R. Evaluation of four vital pulp therapies for primary molars using a dual-cured tricalcium silicate (TheraCal PT): one-year results of a non-randomized clinical trial. J Clin Pediatr Dent. 2023 Mar;47(2):10-22. doi: 10.22514/jocpd.2023.004. Epub 2023 Mar 3.
- Results publicationMoselhy YH, Elghazawy RK, Wassel MO. Clinical and radiographic evaluation of indirect and direct pulp capping in primary molars using TheraCal (LC): a randomized clinical trial. Egyptian Dental Journal. 2022;68(4):3065-3076
- Results publicationGaber RM, Mhmoud SA, Nagi PN. Clinical and radiographic success rate of TheraCal PT versus MTA in pulpotomy of primary molars: a randomised clinical pilot study. Alexandria Dental Journal. 2024;49(1):162-169.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly in order to protect participant confidentiality and privacy, in accordance with the ethical approval guidelines and data protection procedures of the Faculty of Dentistry, Cairo University.
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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.
Reem Gaber Mohamed, Principal Investigator / PhD C contact
Manal Ahmed ElSayed Ahmed Study Director / Main Supervisor, Prof. Dr. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2.5% Sodium Hypochlorite applied to pulpal tissue/stumps for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy and 15% Ferric Sulfate (Astringedent™ 15.5%) in people with Reversible Pulpitis and Dental Caries, run by Reem Mohamed Gaber 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 7 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 15 Oct 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?
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 Reem Gaber Mohamed, Principal Investigator / PhD C (00201115578688 ext. 01115578688, reem.gaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Clinical Success Rate (time frame: Assessed at 3, 6, 9, and 12 months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07876934, which also lists 5 linked publications.
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 15 Oct 2026.