The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .

NCT ID: NCT03298165

Last Updated: 2018-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2018-06-30

Brief Summary

This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.

Detailed Description

each patient should have at least two deep carious lesions The first clinical step in all teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the lateral walls of the cavity and at the enamel-dentin junction was completely removed with excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic biomasses and superficial part of the necrotic and demineralized dentin were removed. then excavation continued until the pulp exposure would occur with further excavation; thus, a layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.

A dentine samples will be then collected from the base of the cavity using sterile spoon excavator from the both groups for baseline bacteriological assessment and another sample will be taken after disinfection with diode laser in the intervention group .

In the two groups The remaining innermost layer of carious dentin are covered with calcium hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer) after a 6 month period. This time was considered adequate for calcium hydroxide to exert its effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were followed up every month and the integrity of the temporary restoration checked. After this interval of 6 months. After the rubber dam application, the temporary filling is removed samples are collected and the teeth are finally restored

Conditions

Antibacterial Effect of Diode Laser

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

disinfection the cavity with diode laser

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

Group Type: EXPERIMENTAL

diode laser

Intervention Type: DEVICE

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

no cavity disinfection

placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .

Group Type: PLACEBO_COMPARATOR

diode laser

Intervention Type: DEVICE

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

Interventions

diode laser

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Patients with at least two deep occlusal carious lesion .

2. 18 - 25years.

3. Males or Females.

4. Good oral hygiene.

5. Co-operative patients approving the trial and willing to sign a written consent.

Exclusion Criteria

1. Pregnancy.

2. Systemic disease or severe medical complications.

3. Heavy smoking.

4. Xerostomia.

5. Lack of compliance.

6. Evidence of temporomandibular joint disorders.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

shahenda gamal tawfik hamdy

internal resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

cebc-cu-2017-09-25

Identifier Type: -

Identifier Source: org_study_id