Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04565912
Collaborator
(none)
37
2
14.9

Study Details

Study Description

Brief Summary

In patients with high caries risk, will the use of sage extract or chlorohexidine based mouthwashes have an effect on the percentage recovery of Streptococcus Mutans (SM) and its pathogenicity detected by Real-Time Polymerase Chain Reaction (PCR) over one month follow up

Condition or Disease Intervention/Treatment Phase
  • Drug: Sage extract mouthwash
  • Drug: Chlorohexidine based mouthwash
N/A

Detailed Description

The clinical study will be held in the clinic of conservative department, Faculty of Dentistry, Cairo University. The operator in charge will be Dina Fayez Diab. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explained to the selected patients for participation in the study. In the first visit , ADA caries risk assessment model will be done. Participants will be divided in to two groups according to the tested mouthwashes.

All patients will be instructed not to have a breakfast and to refrain any oral hygiene measures on the day of sample collection to avoid the influence of food consumption and contamination on the composition of saliva. The patient will sit in an erect position on the dental chair and will be given paraffin block to chew. The stimulated saliva will be collected after 2 minutes of paraffin chewing in sterile container held near the mouth. The containers will be properly labelled.

This study will be carried over one month , the saliva samples for each patients will be collected on the first dental visit. These samples will be sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking allowed for at least 30 minutes post rinsing. Each patient will be given the same instructions with respect to oral hygiene measures. They will be advised to continue on the same diet and will be instructed not to change their dietary habits.

Patients will come after 2 weeks for salivary samples collection and samples will be sent to laboratory for microbiological assessment. After completing the treatment for another 2 weeks , patients will come for the last dental visit to collect salivary samples which will be sent to laboratory for microbiological assessment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
37 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Sage Extract or Chlorohexidine Mouthwashes on Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients : A Randomized Clinical Trial
Anticipated Study Start Date :
Jul 6, 2021
Anticipated Primary Completion Date :
Oct 1, 2021
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sage extract mouthwash

Natural product mouthwash

Drug: Sage extract mouthwash
Patients will be exposed to sage extract mouthwash and will be instructed to use 10 ml of sage extract mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month.
Other Names:
  • Natural product mouthwash
  • Active Comparator: Chlorohexidine mouthwash

    Synthetic mouthwash

    Drug: Chlorohexidine based mouthwash
    Patients will be exposed to Chlorohexidine based mouthwash , and will be instructed to use 10 ml of 0.12% chlorohexidine based mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month
    Other Names:
  • Synthetic mouthwash
  • Outcome Measures

    Primary Outcome Measures

    1. Total bacterial count [1 month]

      Quantitative plating ( standard plate count or SPC) will be used to determine the number of bacteria in a culture sample. SPC reveals information on viable organisms only, bacteria colonies that are seen in the plates after incubation represent only the living organisms, not dead ones

    Secondary Outcome Measures

    1. Bacterial identification [1 month]

      Total extraction of DNA: Total plasmid DNA will be prepared. The solution will be centrifuged and then left at room temperature for few minutes for the phase separation. The aqueous phase containing DNA will be transferred to clean eppendorf Real-Time Polymerase Chain Reaction: the PCR will be done in 20 ul reaction volume containing : DNA template, enzymes primer and nuclease- free water. The tubes containing the PCR mixture will be transferred to the cycler apparatus. The PCR products will be analyzed in agarose gel by electrophoresis, photographed and analyzed

    2. Total protein profile [1 month]

      Proteins can be separated according to their molecular weight by Sodium dodecyl sulphate poly acrylamide gel electrophoresis (SDS-PAGE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • patients will be recruited in this study, all volunteers participated will be medically free Age range 20-50

    • Patients with high caries risk assessment according to ADA caries risk assessment model High plaque index (>score 2 )

    • Non smoking patients

    • Patients with normal salivary rate ( 0.3-0.4 ml/min)

    • Not under antibiotic therapy either time of the study or up to the last month before the begging of the study

    • Male or female patients.

    Exclusion Criteria:
    • patients with a compromised medical history.

    • Patients with low caries risk assessment according to ADA caries risk assessment model.

    • Patients with sever or active periodontal disease.

    • Patients with a history of allergy to any of drugs or chemicals used in this study.

    • Smoking patients

    • Patients with abnormal salivary rate

    • Pregnant female patients.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dina Fayez Shebl Diab, Principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04565912
    Other Study ID Numbers:
    • 20788
    First Posted:
    Sep 25, 2020
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jan 26, 2021