Dental Caries Clinical Trial
Official title:
The Anticariogenic Effect of Miswak (Silvadora Persica) and Grape Seed Extract
| 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 |
| Verified date | October 2019 |
| Source | Al-Azhar University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Egypt | Al Azhar University | Cairo | Nasr City |
| Lead Sponsor | Collaborator |
|---|---|
| Al-Azhar University |
Egypt,
| 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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