Evaluation of Conservative Management of Teeth With Deep Cavitated Carious Lesions

NCT06171776 | Unknown Phase 2 DMC

• 1 other identifier: 345
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare postoperative pain of calcium silicate cement and resin-based tricalcium silicate (TheraCal LC) versus chemically Cured Glass Ionomer cement (FujiXI) in conservative management of very deep carious lesions by selective caries removal

Conditions

Deep Caries; Pulp Exposure, Dental

Outcome Measures

Primary Outcomes (1)

• postoperative pain (binary)

  pain after restoration of teeth using cold test

  one week to 24 months

Secondary Outcomes (1)

• periapical pathosis detection using digital periapical radiograph

  one week to 24 months

Study Arms (3)

fuji XI

ACTIVE COMPARATOR

chemically cured glass ionomer

Drug: Fuji IX

RetroMTA

EXPERIMENTAL

cacium silicat cement

Drug: RetroMTA

Theracal LC

EXPERIMENTAL

resin based calcium silicate cement

Drug: TheraCal

Interventions

RetroMTA DRUG

calcium silicate lining material work as dentin substitute

Also known as: MTA

RetroMTA

TheraCal DRUG

calcium silicat material light cured

Also known as: resin based calcium silicat

Theracal LC

Fuji IX DRUG

filling material bonded chemically to the tooth structure

Also known as: chemically cured glass

fuji XI

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients male or female older than 18 y in good general health
• A minimum of 1 deep carious lesion penetrating three-quarters or more into the dentine as identified with the periapical (PA) radiograph; 3-Clinically according to International Caries Detection and Assessment System (ICDAS II) score 4 (Clinical symptoms of reversible pulpitis)
• \. Positive pulp response to thermal stimulation (cold test) 5. No PA changes viewed on PA radiograph

You may not qualify if:

• Clinical symptoms of irreversible pulpitis requiring endodontic treatment 2. Presence of fistulas or swelling 3. Mobile teeth or tenderness to percussion 4. Anterior teeth with aesthetic concerns 5. Pregnant women, in view of requirements for radiographs 6. Patients younger than 18 y 7. Patients unable to give consent

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Omnia Magdy

Cairo, 02, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Exposure

Interventions

mineral trioxide aggregate; Pemetrexed; TheraCal; fuji IX

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of esthetic and conservative dentistry, faculty of dentistry, Cairo University, Egypt

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 15, 2023
• Study Start: January 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: December 15, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)