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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03731780

Enrollment

Registered

2018-11-06

Start date

2018-12-31

Completion date

2020-07-31

Last updated

2018-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

caries, prevention, personalized medicine

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

Interventions

OTHERPersonalized Treatment

Targeting individual caries risk factors

OTHERChlorhexidine and Remineralization

chlorhexidine mouth wash and remineralizing agent

OTHERControl

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
incidence of new caries lesions	12 month	incidence of new caries lesions

Countries

Egypt

Contacts

Primary Contactsherif khadr, Msc

sherifkhadr@hotmail.com+201007777939

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026