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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03731780

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Other: Personalized Treatment Other: Chlorhexidine and Remineralization Other: Control	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

81 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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.

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Dec 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

incidence of new caries lesions [12 month]
incidence of new caries lesions

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

High caries risk patients
18-25 years
Males or Females
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Study Chair: Fawzi, PhD, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sherif Khadr, Doctoral Candidate, Cairo University

ClinicalTrials.gov Identifier:

NCT03731780

Other Study ID Numbers:

2018cons1

First Posted:

Nov 6, 2018

Last Update Posted:

Nov 7, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sherif Khadr, Doctoral Candidate, Cairo University

caries, prevention, personalized medicine

Additional relevant MeSH terms:

Dental Caries

Chlorhexidine

Study Results

No Results Posted as of Nov 7, 2018