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Clinical Evaluation and Microbiological Assessment of Diode Laser and Chemical Disinfection in Comparison to Selective Caries Removal

NCT03955341 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-09-13

No results posted yet for this study

Summary

Objectives: To evaluate the clinical and antimicrobial effect of Diode laser and chemical disinfection in comparison to selective caries removal in management of deep carious lesions.

Methods: This study will be carried on 30 patients with an age range of 18 -50 years. The patients will be selected from the outpatient clinics in Faculty of Oral and Dental Medicine, Misr International University. All patients will be randomly divided into 3 equal groups; Control group, Diode laser application with an output power of 0.5 watt group, and Chemical disinfection group. Preoperative clinical assessment and radiographs will be performed before intervention and then the patients will receive their treatment and final restorations. Follow-up with clinical assessments will be performed after 3 and 6 months. Cone beam computed tomography will be performed at the day of intervention and after 6 months. Clinical, Microbiological and Radiographic data will be collected, tabulated and statistically analyzed to compare between the success rates of diode laser, chemical disinfection and conventional selective caries removal.

Conditions

  • Patients With Deep Carious Lesions

Interventions

DEVICE

Diode laser disinfection

After collecting the first sample of dentin as described above, the cavity will be disinfected using Diode laser (EPIC™, BIOLASE) with 940 nm and an output power of 0.5 watt (24). A 400 µm noninitiated tip will be used for cavity irradiation, in a noncontact mode (2mm distance), 5 sec/mm2 in sweeping motion. A 2nd dentinal sample will be collected after diode laser disinfection.

OTHER

Chemical disinfection using 2% Chlorhexidine

After collecting the first sample of dentin, the cavity will be disinfected using 2% Chlorhexidine (Consepsis®, Ultradent) for 20 seconds (32). Then a 2nd dentinal sample will be collected after chemical disinfection.

Sponsors & Collaborators

  • Misr International University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-20
Primary Completion
2021-04-15
Completion
2021-06-25

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03955341 on ClinicalTrials.gov