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

NCT06524921 | Completed

• 1 other identifier: 2024-1
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical

  Twelve Months

Study Arms (2)

Metapex

ACTIVE COMPARATOR

Partial pulpectomy using Calcium Hydroxide with Iodoform (Metapex ) in carious primary molars with irreversible pulpitis

Procedure: dental pulpectomy using metapex

Biodentine

EXPERIMENTAL

Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis

Procedure: dental pulpotomy using biodentine

Interventions

dental pulpotomy using biodentine PROCEDURE

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.

Biodentine

dental pulpectomy using metapex PROCEDURE

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.

Metapex

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mohamed Ahmed Hamdi Abo El Yamin: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Marwa Salamoon, Ph.D

  Lecturer of Pediatric Dentistry and Dental Public Health MSA University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: PICO: Population: Children with vital deeply carious primary molars with irreversible pulpitis Intervention: Pulpotomy using Biodentine in carious primary molars with irreversible pulpitis. Comparator/Control: Parial pulpectomy using Calcium Hydroxide with Iodoform ( Metapex ) in carious primary molars with irreversible pulpitis. Outcomes: Primary outcome, The presence of any adverse radiographic findings (Periodontal membrane space widening, periapical radiolucency, bone resorption, or other pathological changes)

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: July 29, 2024
• Study Start: October 1, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 15, 2025
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

EG (1)