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

Not Applicable

• Conditions: Dental Caries
• Interventions: Other: Personalized Treatment; Other: Control; Other: Chlorhexidine and Remineralization

• Registration Number: NCT03731780
• Lead Sponsor: Cairo University

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

Study Timeline

• Study First Submitted: 2018-10-31
• Status Verified: 2018-11
• Study First Submitted QC: 2018-11-05
• Last Update Submitted: 2018-11-05
• Study First Posted: 2018-11-06
• Last Update Posted: 2018-11-07
• Study Start: 2018-12
• Primary Completion: 2020-03
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

1. High caries risk patients
2. 18-25 years
3. Males or Females
4. Patients approving to participate in the study -

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personalized Treatment	Personalized Treatment	Intervention by (standard preventive measures + targeting individual caries risk factors)
Control	Control	standard preventative measures (tooth brushing, fluoride tooth paste, interdental cleaning)
Chlorhexidine and Rremineralization	Chlorhexidine and Remineralization	Intervention is (chlorhexidine + Remineralizing agent + standard preventive measures)

Primary Outcome Measures

Name	Time	Method
incidence of new caries lesions	12 month	incidence of new caries lesions

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt