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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04136639
Other study ID # REC17-082
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2019
Est. completion date October 1, 2019

Study information

Verified date October 2019
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Prevention of dental caries has taken a great importance in the last decade. The use of herbal and natural products became mandatory to avoid the side effects of commercially available medications. Aim of the study; the aim was to investigate the anti-cariogenic effect of miswak and grape seed extract (GSE).


Description:

Patients used Miswak sticks, grape seed extract mouth wash and fluoride mouthwash twice daily for three month. Saliva samples were collected at base line and after one month and three month. Assessment of bacterial count and saliva buffering capacity were performed at base line and after one and three month.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 1, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients with high caries risk

- Males or females

- Medically free patients

- Patients approving to participate in the study

Exclusion Criteria:

- Patients who were on antibiotic therapy or corticosteroid therapy for 30 days before the examination

- Patients had history of professional cleaning in the last 15 days

- Patients with exposed pulp

- Evidence of parafunctional habits

- Patients with developmental dental anomalies

- Patients undergoing or will start orthodontic treatment

- Patients with removable prosthesis

- Periapical Abscess or Fistula

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Miswak
sticks
Grape Seed Extract Mouthwash
Mouthwash
fluoride
mouthwash

Locations

Country Name City State
Egypt Al Azhar University Cairo Nasr City

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary quantitative measure of the change in salivary streptococcus mutans Count from baseline to one month and three months. the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline,after one month and after three months. Every time samples were incubated with Mitiis Salivaris with Bacitricin and 20% sucrose for streptococcus mutans count. Baseline, one month, three months.
Secondary quantitative measure of the change in saliva buffering capacity from baseline to one month and three months. the patients used the treatments twice daily for three months. unstimulated saliva samples were collected from the patients at baseline, after one month and after three months. each time, saliva buffering capacity was measured using Hand Held pH meter and 0.1 mol/l hydrochloric acid that was titrated to the tested saliva. baseline, one month , three months
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