Clinical trial NCT06683833: Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Teeth
Official title: Comparative Analysis of Egyptian MTA, Biodentine, and Calcium Hydroxide as Indirect Pulp Capping Materials in Permanent Teeth. (A 6m Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Deep Caries
Indirect Pulp Capping
Mineral Trioxide Aggregate (MTA)
Calcium Hydroxide
Biodentine
Patient Reported Outcome Measures
Keywords: Deep caries
Indirect pulp capping
Mineral trioxide aggregate (MTA)
Calcium hydroxide
Biodentine
Patient reported outcomes measures (PROMS)
Randomized clinical trial
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 35
Sex: ALL
Minimum age (years): 22
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: Clinical assessment of treatment success
timeFrame: T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months
Secondary outcomes:
measure: Clinical assessment of pain
timeFrame: T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months
measure: Patient satisfaction with the treatment
timeFrame: T( time) T0= 1 week after, T1= 3 months , T2= 6 months
Other outcomes:
Locations:
Study officials:
References: