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

NCT ID: NCT06683833

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-20
• Study Completion Date: 2025-09-20

Brief Summary

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

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

Conditions

Deep Caries; Indirect Pulp Capping; Mineral Trioxide Aggregate (MTA); Calcium Hydroxide; Biodentine; Patient Reported Outcome Measures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Egyptian MTA

Intervention Type: DRUG

• 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.

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.

Group Type: EXPERIMENTAL

Biodentine

Intervention Type: DRUG

• 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.

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.

Group Type: ACTIVE_COMPARATOR

Calcium Hydroxide (Ca(OH)2)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Talaat Mostafa Elsorogy

Dentist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Alaa T Elsorogy, Master's candidate

Role: CONTACT

alaa.elsorogy@dentistry.cu.edu.eg

0020201010009938

Rawda H AbdElAziz

Role: CONTACT

rawda.hesham@dentistry.cu.edu.eg

0020201001097200

Other Identifiers

operative 2

Identifier Type: -

Identifier Source: org_study_id