Back to resultsPersonalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Personalized Treatment
Chlorhexidine and Remineralization
Control
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring caries, prevention, personalized medicine
Eligibility Criteria
Inclusion Criteria:
- High caries risk patients
- 18-25 years
- Males or Females
- Patients approving to participate in the study -
Exclusion Criteria:
- Patients with systemic conditions
- Current periodontitis (sites of probing pocket depth ≥ 5 mm)
- Allergy to any of the ingredients of the study products
- Evidence of parafunctional habits
- Dysfunction of temporomandibular joint
- Use of antibiotics in the previous 30 days
- Patients with developmental dental anomalies
- Patients with removable prosthesis
- Patients with Orthodontic appliance
- Periapical Abscess or Fistula and exposed pulps.
Sites / Locations
- Cairo University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Personalized Treatment
Chlorhexidine and Rremineralization
Control
Arm Description
Intervention by (standard preventive measures + targeting individual caries risk factors)
Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)
standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)
Outcomes
Primary Outcome Measures
incidence of new caries lesions
incidence of new caries lesions
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03731780
Brief Title
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults
Official Title
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Basic standard of care emphasis only tooth brushing and flossing without addressing individual pathological factors. For this reason, randomized controlled clinical trials on personalized caries management are needed to be able to compare the effectiveness of personalized caries management to basic standard of care. This is especially true in high caries risk populations and more so for young adults who stand to benefit the most from working towards a caries free adulthood.
Detailed Description
Aim of the study: is to conduct an RCT to compare the effectiveness of a new personalized caries-control treatment protocol with standard caries treatment protocol for reducing caries incidence in high caries risk patients
Hypothesis: This project will be designed to test the null hypothesis that there is no significant difference between the new personalized caries-control treatment protocol and existing standard caries treatment protocol, and to test the alternative hypothesis that the new personalized treatment protocol will be superior to the standard preventive measures
Primary objective: is to measure the incidence of new caries lesions
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
caries, prevention, personalized medicine
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The recruiter will be blinded. The operator cannot be blinded because of the different in the procedures of caries prevention applied in each group. However, the assessors will be kept unaware of the treatment assigned to the patient.
Allocation
Randomized
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Personalized Treatment
Arm Type
Experimental
Arm Description
Intervention by (standard preventive measures + targeting individual caries risk factors)
Arm Title
Chlorhexidine and Rremineralization
Arm Type
Experimental
Arm Description
Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)
Intervention Type
Other
Intervention Name(s)
Personalized Treatment
Intervention Description
Targeting individual caries risk factors
Intervention Type
Other
Intervention Name(s)
Chlorhexidine and Remineralization
Intervention Description
chlorhexidine mouth wash and remineralizing agent
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)
Primary Outcome Measure Information:
Title
incidence of new caries lesions
Description
incidence of new caries lesions
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
High caries risk patients
18-25 years
Males or Females
Patients approving to participate in the study -
Exclusion Criteria:
Patients with systemic conditions
Current periodontitis (sites of probing pocket depth ≥ 5 mm)
Allergy to any of the ingredients of the study products
Evidence of parafunctional habits
Dysfunction of temporomandibular joint
Use of antibiotics in the previous 30 days
Patients with developmental dental anomalies
Patients with removable prosthesis
Patients with Orthodontic appliance
Periapical Abscess or Fistula and exposed pulps.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sherif khadr, Msc
Phone
+201007777939
Email
sherifkhadr@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fawzi, PhD
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Cairo University
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be made available after publication upon request
IPD Sharing Time Frame
12 month after publication , data will be available upon request
IPD Sharing Access Criteria
principal investigator to be contacted by email for data access
Learn more about this trial
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults
We'll reach out to this number within 24 hrs