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

NCT ID: NCT03731780

Last Updated: 2018-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-31

Study Completion Date

2020-07-31

Brief Summary

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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

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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

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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Personalized Treatment

Intervention by (standard preventive measures + targeting individual caries risk factors)

Group Type EXPERIMENTAL

Personalized Treatment

Intervention Type OTHER

Targeting individual caries risk factors

Chlorhexidine and Rremineralization

Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)

Group Type EXPERIMENTAL

Chlorhexidine and Remineralization

Intervention Type OTHER

chlorhexidine mouth wash and remineralizing agent

Control

standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)

Interventions

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Personalized Treatment

Targeting individual caries risk factors

Intervention Type OTHER

Chlorhexidine and Remineralization

chlorhexidine mouth wash and remineralizing agent

Intervention Type OTHER

Control

Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sherif Khadr

Doctoral Candidate

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fawzi, PhD

Role: STUDY_CHAIR

Cairo University

Locations

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Cairo University

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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sherif khadr, Msc

Role: CONTACT

+201007777939

Other Identifiers

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2018cons1

Identifier Type: -

Identifier Source: org_study_id

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