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

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ClinicalTrials.gov Identifier: NCT03955341
Recruitment Status : Not yet recruiting
First Posted : May 20, 2019
Last Update Posted : August 16, 2019
Sponsor:
Information provided by (Responsible Party):
Misr International University

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.


Condition or disease Intervention/treatment Phase
Patients With Deep Carious Lesions Device: Diode laser disinfection Other: Chemical disinfection using 2% Chlorhexidine Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Clinical Evaluation and Microbiological Assessment of Diode Laser and Chemical Disinfection in Comparison to Selective Caries Removal in Management of Patients With Deep Carious Lesions: A Clinical Pilot Study
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
No Intervention: conventional selective caries removal without disinfection
After collecting the first sample of dentin, the cavity will be restored
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.
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.

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.
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.




Primary Outcome Measures :
  1. Maintaining pulp vitality [ Time Frame: ''through study completion, an average of 6 months" ]

    measuring device

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



Secondary Outcome Measures :
  1. Remaining dentin density [ Time Frame: "6 months" ]
    Cone Beam Computed Tomography

  2. Reducing microbiological count [ Time Frame: "up to 1 week" ]
    Colony counter



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patient-related criteria:

    1. Medically compromised patients.
    2. Pregnant women.
    3. Allergy to any of the restorative materials, including anesthetics.
    4. Uncooperative patients.

Tooth-related criteria:

  1. Deciduous teeth.
  2. Teeth with previous restorations.
  3. Spontaneous pain or prolonged pain (more than 2 minutes) after sensitivity tests (cold and electrical tests).
  4. Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion before signing the consent form.
  5. Teeth presenting external or internal resorption, with adverse pulpal reactions.
  6. Teeth with cervical caries.
  7. Teeth showing signs of periodontitis following AAP 2017 criteria.

3. Justification of Exclusions:

Patient-related:

  1. Medically compromised patients, as they will not be able to attend multiple appointments or may require special management.
  2. Pregnant women; as radiographs cannot be taken for them.
  3. Allergy to any of the restorative materials, including anesthetics.
  4. Uncooperative patients will not abide by the instructions or attend the appointments.

Tooth-related:

  1. Deciduous teeth; as the study is targeting only permanent teeth.
  2. Teeth with previous restorations, which may add another variable to the study (type of old restorative material, extent of recurrent caries).
  3. Spontaneous pain or prolonged pain after sensitivity tests (cold and electrical tests), which would indicate irreversible pulpal damage.
  4. Negative sensitivity tests, periapical radiolucencies and sensitivity to axial or lateral percussion, which would indicate pulp necrosis before signing the consent form.
  5. Teeth presenting external or internal resorption, with adverse pulpal reactions, which may affect the outcome of the study.
  6. Teeth with cervical caries; which can't be evaluated on periapical radiographs.
  7. Teeth showing signs of periodontitis following AAP 2017 criteria, which may affect the outcome of the study.

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Responsible Party: Misr International University
ClinicalTrials.gov Identifier: NCT03955341     History of Changes
Other Study ID Numbers: MIU-IRB -1819-074
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: August 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The original data will be entered in secured database and data will be printed and saved in a secure locker to be shared with supervisors for reviewing and then to the biostatistian for statistical analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents