Grape Seeds Versus Standard Measures for Prevention of Caries Incidence
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The objective is to conduct an randomized controlled clinical trial to evaluate the effectiveness of grape seeds extract mouth wash in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients. This study will be designed to test the alternative hypothesis that using grape seed extract mouth wash in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2018
CompletedFirst Posted
Study publicly available on registry
October 30, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 2, 2018
October 1, 2018
1.1 years
October 28, 2018
October 31, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
caries incidence
visual inspection of new carious lesions
12 months
Study Arms (3)
standard preventive measures
SHAM COMPARATORthe participants will only follow standard preventive measure twice a day brushing with fluoride toothpaste and flossing once a day
antimicrobial and fluoride mouth wash
ACTIVE COMPARATORparticipants will use mouth wash contains both chlorhexidine and fluoride in addition to standard preventive measures
grape seeds extract mouth wash
EXPERIMENTALthe intervention is grape seeds extract mouth wash
Interventions
participants will use grape seeds extract mouth wash in addition to standard preventive measures
twice daily brushing with fluoride tooth pate and daily flossing
using chlorhexidine and fluoride containing mouth wash
Eligibility Criteria
You may qualify if:
- patients with High caries risk
- years
- Males or females
- Medically free patients
- Patients approving to participate in the study
You may not qualify if:
- Patients 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 28, 2018
First Posted
October 30, 2018
Study Start
January 1, 2019
Primary Completion
February 1, 2020
Study Completion
March 1, 2020
Last Updated
November 2, 2018
Record last verified: 2018-10
Data Sharing
- IPD Sharing
- Will not share