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

NCT ID: NCT04565912

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-06
• Study Completion Date: 2022-10-01

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

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.

Conditions

Streptococcus Mutans

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Sage extract mouthwash

Natural product mouthwash

Group Type: EXPERIMENTAL

Sage extract mouthwash

Intervention Type: DRUG

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.

Chlorohexidine mouthwash

Synthetic mouthwash

Group Type: ACTIVE_COMPARATOR

Chlorohexidine based mouthwash

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Natural product mouthwash; Synthetic mouthwash

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Dina Fayez Shebl Diab

Principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20788

Identifier Type: -

Identifier Source: org_study_id