Clinical trial NCT04566120: Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients
Official title: Detection of Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients Using Cinnamon Extract or Chlorohexidine Mouthwashes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Streptococcus Mutans
High Caries Risk Patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-09-28
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In patients with high caries risk, will the use of cinnamon extract or chlorohexidine based mouthwashes have an effect on the percentage of recovery and cariogenicity of Streptococcus mutans (SM) detected by real-time Polymerase Chain Reaction (PCR) over one month follow up

Detailed description: This clinical study will be held in the clinic of conservative dentistry department, Faculty of Dentistry, Cairo University. The operator in charge will be Mostafa Mahmoud El-Ghazali. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explaned to the selected patients, written informed consent will be obtained from the patients for participation in the study. In the first visit, ADA caries risk assessment model will be done. Participants will be divided into two groups according to the tested mouthwashes.

All patients will be instructed not to have 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 containers held near the mouth. The containers will be properly labeled. The study will be carried over a period of one month, the saliva samples for each patient will be collected on the ﬁrst dental visit. These samples will be then sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and they will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking permitted for a minimum of 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 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 the laboratory for microbiological assessment. After treatment continuity for another 2 weeks, patients will come for the last visit to collect the salivary samples which will be sent to the laboratory for microbiological assessment.

Eligibility criteria: Inclusion Criteria:

* Adults will be recruited in this study, all the volunteers participated in this experiment will be healthy looking with free medical history.
* Age range 20-50 years
* High caries risk patients 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).

Exclusion Criteria:

* Patients with a compromised medical history.
* Participants with low caries risk.
* Patients with severe or active periodontal disease.
* Participants with a history of allergy to any of the drugs or chemicals used in the study.
* Patients on any antibiotics during the past month
* Smoking patients.
* Patients with abnormal salivary rate.
* Pregnant female patients

Primary outcomes:
measure: Total bacterial count
timeFrame: 1 month
Secondary outcomes:
measure: Bacterial Identification
timeFrame: 1 month
measure: Glycosyltransferase B & D gene expression.
timeFrame: 1 month
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Uniuversity
Study officials:
affiliation: Assistant Lecturer
name: Mostafa El-Ghazali
role: PRINCIPAL_INVESTIGATOR
References: