NCT06683833

Brief Summary

Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth

Trial Health

77
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at below P25 for phase_4

Timeline
2mo left

Started Sep 2025

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
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 Progress81%
Sep 2025Jul 2026

First Submitted

Initial submission to the registry

November 8, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 12, 2024

Completed
10 months until next milestone

Study Start

First participant enrolled

September 3, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

November 8, 2024

Last Update Submit

March 17, 2026

Conditions

Indirect Pulp CappingMineral Trioxide Aggregate (MTA)Calcium HydroxideBiodentinePatient Reported Outcome MeasuresDeep Caries

Keywords

Deep cariesIndirect pulp cappingMineral trioxide aggregate (MTA)Calcium hydroxideBiodentinePatient reported outcomes measures (PROMS)Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

  • Clinical assessment of treatment success

    Pulp response to different stimuli by thermal and electrical pulp tests. When tooth normally responds to thermal and electrical pulp tests = success When tooth doesn't respond to thermal and electrical pulp tests = failure

    T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months

Secondary Outcomes (2)

  • Clinical assessment of pain

    T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months

  • Patient satisfaction with the treatment

    T( time) T0= 1 week after, T1= 3 months , T2= 6 months

Study Arms (3)

Egyptian MTA

EXPERIMENTAL

* Complete caries removal from the cavity. * The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions. * The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Drug: Egyptian MTA

Biodentine

EXPERIMENTAL

* Complete caries removal from the cavity. * Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Drug: Biodentine

Calcium Hydroxide

ACTIVE COMPARATOR

* Complete caries removal from the cavity. * According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Drug: Calcium Hydroxide (Ca(OH)2)

Interventions

Egyptian MTADRUG

* Complete caries removal from the cavity. * The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions. * The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Egyptian MTA
BiodentineDRUG

* Complete caries removal from the cavity. * Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Biodentine
Calcium Hydroxide (Ca(OH)2)DRUG

* Complete caries removal from the cavity. * According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Calcium Hydroxide

Eligibility Criteria

Age22 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult patients aged 22: 45 years old.
  • Males or females.
  • Patients with vital teeth with deep carious lesions.
  • Patients in good general health.
  • Good oral hygiene.
  • Co-operative patients who show interest to participate in the study.

You may not qualify if:

  • Patients with systemic diseases.
  • Patients with known allergic or adverse reaction to the tested materials.
  • Patients with bad oral hygiene.
  • Patient who frequently use analgesic or any drugs that could mask the pain.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El Monira General Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

tricalcium silicateCalcium Hydroxide

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Central Study Contacts

Alaa T Elsorogy, Master's candidate

CONTACT

0020201010009938alaa.elsorogy@dentistry.cu.edu.eg

Rawda H AbdElAziz

CONTACT

0020201001097200rawda.hesham@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
* Outcome assessors and analyst will be blinded to the intervention group assigned to the patients. * Participants will be blinded from knowing the material used.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

November 8, 2024

First Posted

November 12, 2024

Study Start

September 3, 2025

Primary Completion

May 3, 2026

Study Completion (Estimated)

July 3, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

EG(1)