An interventional study of 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 Reversible Pulpitis, Dental Caries and Primary Molar Pulpotomy, sponsored by Reem Mohamed Gaber. Not yet recruiting at 1 site in Egypt. Open to participants aged 4 Years to 6 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Reem Mohamed Gaber · Not applicable, Interventional, and Treatment
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.
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.
1,137 studies on the registry are indexed under Dental Caries; 201 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 936 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Applied to pulpal tissue for 3 minutes to achieve hemostasis prior to TheraCal PT placement during primary molar pulpotomy.
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.
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
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%)
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
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.
Time frame: Assessed at 3, 6, 9, and 12 months postoperatively.
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)
Time frame: 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
Time frame: Assessed at baseline, 6, and 12 months postoperatively.
Plan to share: 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.
Start is estimated for Jan 2027; primary completion for Jul 2027, 6 months later.
Of 458 non-industry interventional studies with no phase under Dental Caries, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's planned 6 months is below that.
Counting every sponsor, half of 486 studies reached it within 15 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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