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NCT03731780 Clinical Trial

Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults

Dental Caries Clinical Trial

Official title:
Personalized Caries Management Versus Standard of Care for Preventing Incidence of Caries in Young Egyptian Adults: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT03731780
Other study ID # 2018cons1
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 2018
Est. completion date July 2020

Study information
Verified date November 2018
Source Cairo University
Contact sherif khadr, Msc
Phone +201007777939
Email sherifkhadr@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 81
Est. completion date July 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility Inclusion Criteria:

1. High caries risk patients

2. 18-25 years

3. Males or Females

4. 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Personalized Treatment
Targeting individual caries risk factors
• Chlorhexidine and Remineralization
chlorhexidine mouth wash and remineralizing agent
• Control
Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)

Locations
Country Name City State
Egypt Cairo University Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of new caries lesions incidence of new caries lesions 12 month
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