NCT07066410

Brief Summary

This randomized controlled clinical trial aims to evaluate the effect of two calcium silicate cements-Biodentine and EndoCem-on post-operative pain and treatment success in vital pulp therapy (VPT) for mature permanent mandibular molars diagnosed with irreversible pulpitis. A total of 50 patients will be randomly assigned into two groups to receive pulpotomy using either Biodentine or EndoCem. The trial is triple-blinded, self-funded, and conducted at the Endodontic Department, Faculty of Dentistry, The British University in Egypt.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

2 years

First QC Date

June 30, 2025

Last Update Submit

July 17, 2025

Conditions

Irreversible Pulpitis

Keywords

Vital pulp therapyBiodentineEndocemIrreversible pulpitisMTA PulpotomyPulpotomy in mature teeth

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    Pain intensity measured using the Visual Analogue Scale (VAS), a 100 mm scale ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate worse pain

    Time Frame: at 6 hours, 24 hours, 48 hours, and 72 hours after treatment

Secondary Outcomes (1)

  • Success Rate

    follow up at 3 and 6 months

Study Arms (2)

arm 1 Endocem group

EXPERIMENTAL

Biological/Vaccine: Patients will undergo pulpotomy using EndoCem (Maruchi, Korea) after achieving hemostasis. Same standardized clinical procedure as the Biodentine group, but with EndoCem material used for pulp capping and final restoration placement.

Biological: intervention 1: endocem

arm 2: Biodentine

ACTIVE COMPARATOR

Patients will undergo pulpotomy using Biodentine (Septodont, France) after achieving hemostasis. Standardized clinical procedure including anesthesia, rubber dam isolation, access cavity preparation, coronal pulp removal, and placement of Biodentine followed

Biological: Intervention 1: biodentine

Interventions

intervention 1: endocemBIOLOGICAL

EndoCem, a premixed calcium silicate-based cement (Maruchi, Korea), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, EndoCem is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of EndoCem, followed by immediate restoration with FUJI II ensure a coronal seal.

arm 1 Endocem group
Intervention 1: biodentineBIOLOGICAL

Biodentine, a tricalcium silicate-based cement (Septodont, France), is used as the pulp capping material in vital pulp therapy (VPT). After achieving hemostasis with sterile saline-soaked cotton pellets, Biodentine is applied directly over the exposed radicular pulp tissue. The standardized clinical procedure includes local anesthesia, rubber dam isolation, caries removal, access cavity preparation, coronal pulp removal, and placement of Biodentine, followed by immediate restoration with FUJI II to ensure a coronal seal.

arm 2: Biodentine

Eligibility Criteria

Age12 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patient's age ranges from 12-40 years old.
  • Two Rooted Mandibular Molar teeth diagnosed with symptomatic irreversible pulpitis
  • The teeth are restorable
  • Informed consent granted
  • Teeth are periodontally free, with no mobility and negative to percussion and palpation test.

You may not qualify if:

  • Teeth with immature roots
  • Non restorable teeth
  • Bleeding could not be controlled after pulpotomy in 10 minutes
  • Medically compromised patients with systemic complication that would alter the treatment.
  • Necrotic teeth
  • Inability to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Clinic at the British University in Egypt Hospital

Cairo, Cairo Governorate, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Yasmeen El-shaarawi, BDS, MSc Candidate, Principal Investigator

Study Record Dates

First Submitted

June 30, 2025

First Posted

July 15, 2025

Study Start

October 1, 2023

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

July 22, 2025

Record last verified: 2025-07

Locations

EG(1)