High Caries Risk Patients Clinical Trial
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
Verified date | December 2023 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 37 |
Est. completion date | February 1, 2023 |
Est. primary completion date | December 1, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 50 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo Uniuversity | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total bacterial count | quantitative plating (standard plate count or SPC)n 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 living organisms, not dead ones. | 1 month | |
Secondary | 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 separations. The aqueous phase containing DNA will be transferred to clean eppendorf.
PCR Polymerase chain reaction: The PCR will be performed in 25µl reaction volume containing: DNA template, enzymes, primer and nuclease-free water. The tubes containing the PCR mixture will be transferred to the thermal cycler apparatus. The PCR products will be analyzed in agarose gel by electrophoresis, photographed and analyzed. |
1 month | |
Secondary | Glycosyltransferase B & D gene expression. | The real time PCR for relative quantification of target bacterial genes will be performed in a total volume of 20 µL using 10 µL SYBR® Premix Ex TaqTM master mix, 0.4 µL of each forward and reverse primer, 0.08 µL diluted ROX, and 2 µL of DNA template | 1 month |
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