Effect of Hemostatic Agents on TheraCal PT Pulpotomy Success in Primary Molars

NCT07876934 | Not Yet Recruiting

• 1 other identifier: CU-PEDO-THPT-001.REEMGABER1993
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Reversible Pulpitis; Dental Caries; Primary Molar Pulpotomy; Dental Pulp Exposure

Keywords

TheraCal PT; hemostatic agents; sodium hypochlorite; ferric sulfate; primary molars; vital pulp therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Assessed at 3, 6, 9, and 12 months postoperatively.

Secondary Outcomes (2)

• Overall Radiographic Success Rate

  Assessed at baseline, 6, and 12 months postoperatively.

• Pulp Canal Obliteration (PCO)

  Assessed at baseline, 6, and 12 months postoperatively.

Study Arms (3)

2.5% sodium hypochlorite

EXPERIMENTAL

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%)

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.

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

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%)

Interventions

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

15.5 % ferric sulfate; 2.5% sodium hypochlorite; TheraCal PT pulpotomy with saline (control)

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reem Mohamed Gaber: lead

Study Sites (1)

Postgraduate Outpatients Clinic, Pediatric Dentistry Department, Faculty of Dentistry, Cairo University

Cairo, Cairo Governorate, 11553, Egypt

Location

Related Publications (5)

• 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.

  RESULT

• 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.

  PMID: 32194986 RESULT

• Wassel 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.

  PMID: 36890738 RESULT

• Moselhy 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

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Dental Caries; Dental Pulp Exposure

Interventions

ferric sulfate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Dental Pulp Diseases

Central Study Contacts

Reem Gaber Mohamed, Principal Investigator / PhD C

CONTACT

00201115578688; reem.gaber@dentistry.cu.edu.eg

Manal Ahmed ElSayed Ahmed Study Director / Main Supervisor, Prof. Dr.

CONTACT

00201227332259; manal.elsayed.agha@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor, who performs the blinded clinical and radiographic examinations at follow-up, and the statistician are masked to group allocation. Group allocation is concealed in sequentially numbered, opaque, sealed envelopes prepared by an independent research assistant who is not involved in recruitment, treatment or assessment. The envelope is opened only after coronal pulp amputation, immediately before the hemostatic agent is applied. The operator cannot be masked because the hemostatic agents differ in appearance and application. Participants and their guardians are not formally masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD Candidate in pediatric Dentistry, Cairo University

Model Details: 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."

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)