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

Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).

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.

Study Overview

• Status: Unknown
• Conditions: Antibacterial Effect of Diode Laser
• Intervention / Treatment: Device: diode laser

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

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: diode laser; diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation
Placebo Comparator: no cavity disinfection; placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .	Device: diode laser; diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bacteriological count	dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab	30 minute

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): March 15, 2018
• Study Completion (Anticipated): June 1, 2018

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 2, 2017

Study Record Updates

• Last Update Posted (Actual): January 25, 2018
• Last Update Submitted That Met QC Criteria: January 23, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: cebc-cu-2017-09-25

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No