Biodentine Pulpotomy vs Metapex Pulpectomy in Primary Molars: Clinical & Radiographic Comparison of Outcomes in Irreversible Pulpitis Cases

Clinical and Radiographic Evaluation of Calcium Silicate Cement (Biodentine) Used As A Pulpotomy Agent In Primary Molars With Irreversible Pulpitis Versus Pulpectomy Using Calcium Hydroxide Iodoform Paste (Metapex)

Irreversible pulpitis is defined as a clinical diagnostic based on subjective and objective findings suggesting that the vital inflamed pulp is incapable of healing in the American Association of Endodontists (AAE) Consensus Conference Recommended Diagnostic Terminology. Other characteristics include persistent heat discomfort, transferred pain, spontaneous pain, or no clinical symptoms but caries-induced inflammation, caries excavation, and trauma.".

Dental caries is one of the most frequently occurring diseases affecting human beings that becomes a challenge for dentists as the disease progresses. The ultimate goal of operative and endodontic treatment is to preserve and maintain the vitality of pulp to allow continued development of odontogenic apparatus.

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: dental pulpectomy using metapex; Procedure: dental pulpotomy using biodentine

Detailed Description

Pulp interventions combine a medication with a pulp treatment technique. Preserving the health of the tooth and its supporting tissues is the aim of these procedures. Three pulp therapy options are available, depending on the severity of the disease: pulpectomy, pulpotomy, and direct pulp capping. Direct pulp capping includes applying a medicinal material directly to the exposed pulp; pulpotomy and pulpectomy require removing parts of the pulp or the entire pulp in the pulp chamber and root canal of the tooth. In these procedures, the caries and part of pulp tissue are removed, and then medications are applied. This method aids in preserving the tooth's transient integrity.

When more advanced caries lesions approach the pulp-dentin complex and produce pulp necrosis, endodontic therapy is one way to save primary teeth until exfoliation. Maintaining the child's primary teeth in their oral cavity while getting rid of any symptoms or indicators is the ultimate goal of endodontic therapy in pediatric dentistry (Afroz et al., 2019).

zinc oxide eugenol (ZOE) was Introduced in 1930 and has been the conventional and widely approved root canal filling material for primary teeth. With over 90% of cases successfully reported, studies using ZOE paste have shown moderate to high success rates. But it has some drawbacks as well, such as the slower rate of resorption than the root, the possibility of the developing successor teeth becoming misaligned, particularly in overfilled cases, and worries about the material's potential for reduced antibacterial activity after the material is set in place.

Because zinc oxide eugenol has some disadvantages, biodentine-which may be utilized in direct contact with pulpal tissue-has strong mechanical properties, a good capacity to seal with dentine, and a biocompatibility that is comparable to that of MTA. It fulfilled every requirement of the perfect restorative material, including patient acceptance, good mechanical and physical properties, technical elements from the dentist's perspective, and other clinical characteristics that enhanced the material's efficacy. If only a portion of the odontoblastic layer is damaged, biodentine may accelerate pulp repair and regeneration.

For primary teeth pulpectomy, Metapex (Metapex, Meta Dental, New York, USA) is an easy-to-apply option that combines iodoform and calcium hydroxide. According to studies, this material has a good rate of resorption, less void formation, and excellent clinical and radiographic results.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• • Patient and parent showing cooperation and compliance.

  • Children 4-9 years old
  • Vital deeply carious primary(s) with complete root formation
  • Asymptomatic teeth or without clinical symptoms of spontaneous pain
  • No clinical evidence of pulp degeneration like the history of spontaneous or nocturnal pain, tenderness to percussion, pathologic tooth mobility, swelling, or fistulous tract.
  • Both genders will be included.
  • No radiographic evidence of pulp degeneration such as internal root resorption, external root resorption, or furcal radiolucency.
  • Presence of 2/3rd of root
  • Teeth that can be restored
  • Children with prior parental consent.

Exclusion Criteria:

• • soft tissue inflammation.

  • tooth mobility.
  • sinus tract.
  • Any radiographic sign of periapical pathologies or pulp necrosis (periapical radiolucency, internal or external root resorption)
  • History of any systemic disease
  • Teeth showing clinical or radiographic evidence of pulp degeneration
  • Hemostasis not achieved within 5 minutes of pulp amputation, by direct contact with a wet cotton pellet before the material placement
  • The remaining radicular tissue was non-vital (with suppuration or purulence necrosis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Metapex; Partial pulpectomy using Calcium Hydroxide with Iodoform (Metapex ) in carious primary molars with irreversible pulpitis	Procedure: dental pulpectomy using metapex; Metapex: A dental pulpectomy treats tooth with irreversible pulpitis in primary and teeth by removing infected pulp tissue using files and irrigation in the radicular part. The procedure involves anesthesia, decay removal, pulp chamber access, filing and irrigation till we reach cleaned dried canals and applying a medicament like Metapex . The tooth is then restored with a filling, often a stainless steel crown. The loss of pulp tissue weakens the tooth's structure and increases the risk of fracture and infection.
Experimental: Biodentine; Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis	Procedure: dental pulpotomy using biodentine; Biodentine: A dental pulpotomy treats tooth decay or trauma in primary and young permanent teeth by removing infected pulp tissue in the crown while preserving healthy root pulp. The procedure involves anesthesia, decay removal, pulp chamber access, hemostasis, and applying a medicament like MTA or Biodentine. The tooth is then restored with a filling, often a stainless steel crown. Pulpotomies preserve tooth structure, relieve pain, and are less invasive than full root canals, but require regular follow-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic	Radiographic Furcation involvement: Furcation involvement will be assessed radiographically using DIGORA software, with visual interpretation assigning scores based on radiolucency levels: 0 for no radiolucency; 1 for radiolucency affecting up to ¼ of the furcation area extending towards the periapical region; 2 for radiolucency involving between ¼ and ½ of the furcation area extending towards the periapical region; and 3 for radiolucency affecting more than ½ of the furcation area extending towards the periapical region.	Twelve Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical	The presence of postoperative pain:The Wong-Baker FACES Pain Rating Scale, a self-report tool for acute pain, will be used to assess spontaneous pain and pain on biting. This scale ranges from 0 to 10, with six illustrated faces representing pain levels from "no hurt" to "hurts worst."	Twelve Months

Collaborators and Investigators

• Sponsor: Mohamed Ahmed Hamdi Abo El Yamin
• Investigators: Study Chair: Marwa Salamoon, Ph.D, Lecturer of Pediatric Dentistry and Dental Public Health MSA University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Actual): September 1, 2025
• Study Completion (Actual): September 15, 2025

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 20, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: 2024-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No