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

NCT04565912 | Unknown DMC

• 1 other identifier: 20788
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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

Conditions

Streptococcus Mutans

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bacterial identification

  1 month

• Total protein profile

  1 month

Study Arms (2)

Sage extract mouthwash

EXPERIMENTAL

Natural product mouthwash

Drug: Sage extract mouthwash

Chlorohexidine mouthwash

ACTIVE COMPARATOR

Synthetic mouthwash

Drug: Chlorohexidine based mouthwash

Interventions

Sage extract mouthwash 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.

Also known as: Natural product mouthwash

Sage extract mouthwash

Chlorohexidine based mouthwash 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

Also known as: Synthetic mouthwash

Chlorohexidine mouthwash

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: September 25, 2020
• Study Start: July 6, 2021
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2022
• Last Updated: January 26, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Expecting to have all the data by October 2022