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

Cairo University (CU)

Status: Unknown

Conditions: Dental Caries

Treatments: Other: Control; Other: Personalized Treatment; Other: Chlorhexidine and Remineralization

Study type: Interventional

Funder types: Other

Identifiers

NCT03731780

2018cons1

Details and patient eligibility

About

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.

Full 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

Enrollment: 81 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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81 participants in 3 patient groups

Personalized Treatment

Experimental group

Description:

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

Treatment:

Other: Personalized Treatment

Chlorhexidine and Rremineralization

Experimental group

Description:

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

Treatment:

Other: Chlorhexidine and Remineralization

Control

Active Comparator group

Description:

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

Treatment:

Other: Control