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

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

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

Study Overview

• Status: Unknown
• Conditions: Streptococcus Mutans
• Intervention / Treatment: Drug: Sage extract mouthwash; Drug: Chlorohexidine based mouthwash

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 Type: Interventional
• Enrollment (Anticipated): 37
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total bacterial count	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	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial identification	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	1 month
Total protein profile	Proteins can be separated according to their molecular weight by Sodium dodecyl sulphate poly acrylamide gel electrophoresis (SDS-PAGE)	1 month

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 6, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): January 26, 2021
• Last Update Submitted That Met QC Criteria: January 23, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20788

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Expecting to have all the data by October 2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No