Antibacterial Effect of Nano Silver Fluoride vs Chlorhexidine on Occlusal Carious Molars Treated With Partial Caries Removal Technique
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 3

Summary: 
      -  The teeth of the patients that meet inclusion criteria will be anesthetized, isolated
           with a rubber dam.

        -  Cavity opened using conventional high-speed rotary instruments.

        -  The central cariogenic biomass and the superficial parts of the necrotic dentine will be
           removed with round burs.

        -  Caries lesion will be completely removed in the enamel/dentin junction.

        -  The excavation procedure will be terminated as soon as the soft and wet dentine was
           removed and the remaining tissue was leathery but not hard on exploring.

        -  A dentinal sample will then be collected from the base of the cavity using sterile spoon
           excavator as a baseline for bacteriological assessment.

        -  Then, application of either intervention or control agent, another dentinal sample will
           be collected using a sterile excavator and transferred into sterile tubes and
           transferred to the laboratory for microbiological analysis.

        -  Filling of the cavity with resin composite restoration.

        -  All clinical procedures will be carried out at the same visit.
    

Detailed description: 
      I.1. Study setting This clinical study will be held in the Clinic of Conservative Dentistry
      Department, Faculty of Dentistry, Cairo University, Egypt. The researcher will bear ultimate
      responsibility for all activities associated with the conduct of a research project including
      recruitment of patients, explaining and performing the procedures to them.

      II.4.a Excavation protocol:

      The teeth of the patients that meet inclusion criteria will be anesthetized, isolated with a
      rubber dam. Cavity opened using conventional high-speed rotary instruments. The central
      cariogenic biomass and the superficial parts of the necrotic dentine will be removed with
      round burs. Caries lesion will be completely removed in the enamel/dentin junction. The
      excavation procedure will be terminated as soon as the soft and wet dentine was removed and
      the remaining tissue was leathery but not hard on exploring. A dentinal sample will then be
      collected from the base of the cavity using sterile spoon excavator as a baseline for
      bacteriological assessment. Then, application of either intervention or control agent,
      another dentinal sample will be collected using a sterile excavator and transferred into
      sterile tubes and transferred to the laboratory for microbiological analysis.

      II.4.b Assessment of Outcome:

      Samples of carious dentine will be collected with sterile excavator before and after
      application of intervention/control agent. The dentine samples will be transferred to sterile
      container containing a 1mL thioglycollate medium used as a carrier, then this sterile
      container will be kept in an ice box and taken to the microbiology laboratory for processing,
      within an hour, by another examiner who is blinded to the type of agent applied after partial
      caries removal. Samples will be vortexed for two minutes, decimally diluted and 0.1 ml will
      be plated on Mitis Salivarius Bacitracin agar plates, these plates will be incubated
      anaerobically for 48 hour at 37ºC then aerobically for 24 hour at room temperature. The
      number of colonies will be expressed as colony-forming units (CFU/ml) compared before and
      after application of the antibacterial agent.

      II.5. Participant timeline:

      All clinical procedures will be carried out at the same visit.

      II.6. Sample size calculation:

      The aim of this study is to evaluate the antibacterial action Nano Silver Fluoride solution
      application in comparison to Chlorhexidine solution after partial caries removal in class I
      carious permanent molar. Based on a previous study by Mohan et al. 20165, the expected
      difference between two interventions is expected to be 2.1±2.2CFU/mL × 103. Using power 80%
      and 5% significance level we will need to study 18 in each group to be able to reject the
      null hypothesis that the population means of the experimental and control groups are equal.
      This number is to be increased to 22 patients in each group to compensate for possible losses
      during follow up. The sample size was calculated by PS program.

      II.7. Recruitment:

      Patients will be recruited from outpatient clinic of Conservative Dentistry Department in
      Faculty of Dentistry, Cairo University; after explaining the benefits/risks from the
      application of the interventions, then eligible patients will be recruited to fulfil the
      eligibility criteria according to participant timeline.

      II.8.a. Recruitment Strategy:

      The patients will be subjected to full examination and diagnosis using dental charts. Once
      the patients that are potentially eligible for this study are identified, they will be
      contacted by the researcher who will explain the study and ascertains the patient's interest.
      If interested, more detailed evaluations and preparations are made.

      II.9. Randomization and assignment of interventions:

      II.9.a. Allocation sequence generation:

      The allocation sequence will be generated using (www.randomization.com).

      II.9.b. Allocation concealment mechanism:

      The randomization unit was the tooth, and the randomization procedure will be performed as
      follows. A number corresponding to each treatment group will be printed on pieces of paper
      and kept in dark containers. A paper will be selected from the container by a person other
      than the operator, and the treatment indicated will be performed (intervention/control).
      Blinding of the operator is not possible, because the color of intervention and control
      solution is different. The operator is blinded until randomization into groups, to avoid
      biases with regard to the application of antibacterial agent. Also, the examiner who will
      carry the microbiological analysis of dentin samples will be blinded to the type of agent
      applied during treatment. Finally, the treatment results will be assessed blindly by a
      statistician.

      II.9.c. Implementation:

      Dr. Mai Mamdouh (co-supervisor) will perform the allocation sequence and assign the
      participants to the intervention/Control treatment group.

      II.9.d. Blinding:

      The side to which interventions or control is assigned to will be recorded and all records of
      all patients will be kept with the main supervisor. Blinding of the operator is not possible,
      because the color of intervention and control solution is different. The operator is blinded
      until randomization into groups, to avoid biases with regard to the application of
      antibacterial agent. Also, the examiner who will carry the microbiological analysis of dentin
      samples will be blinded to the type of agent applied during treatment. Finally, the treatment
      results will be assessed blindly by a statistician.

      II.10. Data collection methods:

      *Baseline data collection: For every patient medical history, dental history and examination
      charts will be filled by the operator. The report will be anonymous where patients identified
      by their serial numbers (the first letter of the first and last name and date of birth) only
      will be registered. Full detailed personal data of the patient will be written in separate
      sheet having the patient's serial number for further contact with patient.

      *Outcome data collection: The results will be converted into a table to facilitate the
      description of the results. The microbiological analysis will be performed blindly in
      relation to the type of solution applied after partial caries removal.

      II.11.Data management:

      The data will be entered and stored on a personal computer. Double data entry will be saved
      on an external hard disc to prevent loss of data.

      II.12. Statistical methods:

      Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social
      Sciences), version 21 (SPSS Inc., Chicago, IL). Numerical data will be described as mean and
      standard deviation or median and range. Categorical data will be explored for normality using
      Kolmogrov-Smirnov test and Shapiro-Wilk test. Comparisons between two groups for normally
      distributed numeric variables will be done using the Student's t-test while for non normally
      distributed numeric variables will be done by Mann-Whitney test. Comparisons between
      categorical variables will be performed using the chi square test. A p-value less than or
      equal to 0.05 will be considered statistically significant. All tests will be two tailed.

      II.13. Monitoring:

      II.13.a. Data monitoring:

      The main supervisor will monitor this study. His role is to monitor any risk of bias could be
      done from participants, operator or assessors. Also to monitor blinding of the assessors and
      patient safety, outstanding benefits or harms.

      II.13.b. Harms:

      The main supervisor should inform participants about the possible harms, if present.
      Participants are allowed to contact the operator at moment through telephone. In case of
      accidental pulp exposure during excavation , emergency access cavity and pulp extirpation
      will be done by the operator and then the patient will be referred to Endodontic Department
      clinic to complete the rool canal treatment.

      II.13.c. Auditing:

      In the present trial, auditing will be done by the main and co-supervisors to assure quality
      of the research frequency procedures.

      II.14. Ethics and dissemination

      II.14.a. Research ethics approval:

      Application forms for carrying out the clinical trial, checklist and informed consent of
      Research Ethics Committee (REC) Faculty of Dentistry, Cairo University will be retrieved and
      filled, then will be delivered for (REC) committee for approval. This is done to prevent any
      ethical problems during the study or any harm for any of the participants.

      II.14.b. Protocol amendments:

      If a new protocol will be used a protocol amendment will be submitted; containing a new copy
      of the new protocol and brief explanation about the differences between it and the previous
      protocols. If there is a change in the existing protocol that affects safety of subjects,
      investigation scope or scientific quality of the trial, an amendment containing a brief
      explanation about the change will be submitted. If a new author will be added to accomplish
      the study, an amendment including the investigator's data and qualifications to conduct the
      investigation will be submitted to prevent ghost authorship.

      II.14.c. Consent:

      The operator (Ali Mostafa Shamaa) is responsible for admitting and signing the written
      consents during the enrolment day.

      II.15. Confidentiality:

      Name, personal data and pictures of the participants will not appear on the protocol form and
      will be maintained secured for 10 years after the trial. This is done for protection of
      participants' privacy and civil rights.

      II.16. Declaration of interests:

      There is no conflict of interest, no funding or material supplying from any parties.

      Access to final data will be allowed to the operator ,the main and co-supervisors of the
      study who are not involved in assessment of the outcome.

      II.18. Ancillary and post-trial care:

      Patients will be followed up after the application after 3, 6 months.

      II.19. Dissemination policy:

      Full protocol will be published online in www.clinicaltrials.gov to avoid repetition and to
      keep the integrity of the research work. Thesis will be discussed in front of judgment
      committee. The study will be published to report the results of this clinical trial.
    

Intervention name(s): Nano silver fluoride solution; Cavity Cleanser
Intervention type(s): Drug; Drug
Intervention description(s): Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.; Moistens dentin surface after cavity preparation using a micro brush.
Other intervention name(s): NSF; Chlorhexidine digluconate 2 % solution
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Pharmaceutical Solutions; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment