Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Teeth

Comparative Analysis of Egyptian MTA, Biodentine, and Calcium Hydroxide as Indirect Pulp Capping Materials in Permanent Teeth. (A 6m Randomized Clinical Trial)

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

Study Overview

• Status: Recruiting
• Conditions: Deep Caries; Patient Reported Outcome Measures; Indirect Pulp Capping; Calcium Hydroxide; Biodentine; Mineral Trioxide Aggregate (MTA)
• Intervention / Treatment: Drug: Egyptian MTA; Drug: Biodentine; Drug: Calcium Hydroxide (Ca(OH)2)

Detailed Description

Vital pulp treatments (VPTs) represent a group of minimally invasive treatments intended to preserve the health of all or part of the dental pulp. These treatments include a spectrum of modalities including indirect pulp capping as first option, direct pulp capping and pulpotomy (partial or complete).

Indirect pulp capping (IPC) has been proposed as a conservative pulp therapy for several decades. It is a technique for deep caries management without any features of pulp degeneration.This stimulates tertiary dentin formation, avoiding pulp exposure and maintaining pulp vitality. Cases of indirect pulp capping in deep cavities are those where the residual dentin thickness is equal or less than 0.5 mm, the number and size of the "open" dentinal tubules are such that communication with the pulp parenchyma is comparable to that of a true exposure.

Ideal pulp capping material should maintain pulpal vitality and stimulate reparative dentin formation. These materials should possess certain properties such as biocompatibility, bioactivity, radiopacity, insolubility, dimensional stability, and adequate adhesive ability to both the dentin and to the restorative materials. It should also release remineralizing ions, provide bacterial seal, prevent secondary caries, should have bactericidal or bacteriostatic activity against the causative pathogens, and promote the formation of mineralized tissue

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Alaa T Elsorogy, Master's candidate; Phone Number: 0020201010009938; Email: alaa.elsorogy@dentistry.cu.edu.eg
• Study Contact Backup: Name: Rawda H AbdElAziz; Phone Number: 0020201001097200; Email: rawda.hesham@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • El Monira General Hospital
    • Contact: El Monira General Hospital; Phone Number: 0020223947206

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Egyptian MTA; 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; 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.
Experimental: Biodentine; 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; 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.
Active Comparator: Calcium Hydroxide; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical assessment of pain	Patient reported outcome measures by visual analogue scale visual analogue scale is used to describe the pain by patients themselves in scores as ( 0: no pain ) & (7-10 : Severe pain)	T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months
Patient satisfaction with the treatment	Patient reported outcome measure by 4- point likert scale 4- point likert scale used to describe patient satisfaction with the treatment as " (a) yes, very satisfied" & " (d) not all satisfied"	T( time) T0= 1 week after, T1= 3 months , T2= 6 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2025
• Primary Completion (Estimated): May 3, 2026
• Study Completion (Estimated): July 3, 2026

Study Registration Dates

• First Submitted: November 8, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Randomized clinical trial; Calcium hydroxide; Biodentine; Deep caries; Indirect pulp capping; Mineral trioxide aggregate (MTA); Patient reported outcomes measures (PROMS)
• Additional Relevant MeSH Terms: Inorganic Chemicals; Anions; Ions; Electrolytes; Hydroxides; Alkalies; Calcium Compounds; Calcium Hydroxide; tricalcium silicate
• Other Study ID Numbers: operative 2

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.: Yes