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

November 5, 2018 updated by: Sherif Khadr, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

81

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Personalized Treatment
Intervention by (standard preventive measures + targeting individual caries risk factors)
Other: Personalized Treatment
Targeting individual caries risk factors
EXPERIMENTAL: Chlorhexidine and Rremineralization
Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)
Other: Chlorhexidine and Remineralization
chlorhexidine mouth wash and remineralizing agent
ACTIVE_COMPARATOR: Control
standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)
Other: Control
Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of new caries lesions
Time Frame: 12 month
incidence of new caries lesions
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Fawzi, PhD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2018

Primary Completion (ANTICIPATED)

March 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

October 31, 2018

First Submitted That Met QC Criteria

November 5, 2018

First Posted (ACTUAL)

November 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 7, 2018

Last Update Submitted That Met QC Criteria

November 5, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018cons1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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