Streptococcus Mutans Cariogenicity by Real-time PCR in High Caries Risk Patients

NCT04566120 | Completed DMC

• 1 other identifier: oper131
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Conditions

Streptococcus Mutans; High Caries Risk Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bacterial Identification

  1 month

• Glycosyltransferase B & D gene expression.

  1 month

Study Arms (2)

Cinnamon extract mouthwash

EXPERIMENTAL

Participants will be exposed to cinnamon extract mouthwash and will be instructed to use 10 ml of cinnamon extract mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month.

Drug: cinnamon extract mouthwash

Chlorohexidine based mouthwash

ACTIVE COMPARATOR

Participants will be exposed to chlorohexidine based mouthwash. and will be instructed to use 10 ml of 0.12% chlorhexidine based mouthwash 2 times per day for 1 minute; such a regimen will be continued for one month.

Drug: chlorohexidine based mouthwash

Interventions

cinnamon extract mouthwash DRUG

cinnamon extract mouthwash

Also known as: Natural Product Mouthwash

Cinnamon extract mouthwash

chlorohexidine based mouthwash DRUG

chlorohexidine based mouthwash

Also known as: Synthetic Mouthwash

Chlorohexidine based mouthwash

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo Uniuversity

Giza, Egypt

Location

Study Officials

• Mostafa El-Ghazali

  Assistant Lecturer

  PRINCIPAL INVESTIGATOR

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 28, 2020
• Study Start: January 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: December 13, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Expecting to have all the data by October 2022
• Access Criteria: IPD through contacting the main author mostafa.elghazali@dentistrt.cu.edu.eg

Locations

EG (1)