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

NCT03955341 | Completed DMC

• 1 other identifier: MIU-IRB -1819-074
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Maintaining pulp vitality

  measuring device 1.Cold pulp test Binary (Success/failure) If it is +ve considered success. If it is -ve, considered failure

  ''through study completion, an average of 6 months"

Secondary Outcomes (2)

• Remaining dentin density

  "6 months"

• Reducing microbiological count

  "up to 1 week"

Study Arms (3)

conventional selective caries removal without disinfection

NO INTERVENTION

After collecting the first sample of dentin, the cavity will be restored

Diode laser disinfection

OTHER

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.

Device: Diode laser disinfection

Chemical disinfection using 2% Chlorhexidine

OTHER

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.

Other: Chemical disinfection using 2% Chlorhexidine

Interventions

Diode laser disinfection DEVICE

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.

Diode laser disinfection

Chemical disinfection using 2% Chlorhexidine OTHER

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.

Chemical disinfection using 2% Chlorhexidine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patient-related criteria:
• Between 18-50 years old.
• Gender: both male and female.
• Patients consulting in the MIU outpatient clinic.
• Able to tolerate necessary restorative procedures (anesthesia, cavity preparation, and restorative material placement).
• Provide informed consent.
• Accepts the 6 months follow-up period.
• Tooth related criteria:
• Permanent posterior teeth with primary deep carious lesions involving 2/3 of the entire dentin thickness with no continuity between the carious cavity and the pulp chamber, as assessed by conventional periapical radiographs.
• Teeth are vital according to pulp-sensitivity tests.

You may not qualify if:

• Patient-related criteria:
• Medically compromised patients.
• Pregnant women.
• Allergy to any of the restorative materials, including anesthetics.
• Uncooperative patients.
• Tooth-related criteria:
• Deciduous teeth.
• Teeth with previous restorations.
• Spontaneous pain or prolonged pain (more than 2 minutes) after sensitivity tests (cold and electrical tests).
• Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion before signing the consent form.
• Teeth presenting external or internal resorption, with adverse pulpal reactions.
• Teeth with cervical caries.
• Teeth showing signs of periodontitis following AAP 2017 criteria.
• Patient-related:
• Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.

Sponsors & Collaborators

• Misr International University: lead

Study Sites (1)

Misr International university

Cairo, 11218, Egypt

Location

MeSH Terms

Interventions

Chlorhexidine

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blinded as Outcome assessors will be blinded. Both, the participants and principal investigator cannot be blinded owing to the use of two obviously different methods, laser and chemical disinfection, or no disinfection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: evaluate the clinical outcome (in terms of maintaining pulp vitality, assessed by cold pulp testing, absence of spontaneous pain, sensitivity to percussion, inspection for sinus or fistula or swelling, and radiographically using cone beam computed tomography) and the antimicrobial effect of Diode laser and chemical disinfection in comparison to conventional selective caries removal without disinfection in management of deep carious lesions in permanent posterior teeth.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 20, 2019
• Study Start: October 20, 2019
• Primary Completion: April 15, 2021
• Study Completion: June 25, 2021
• Last Updated: September 13, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)