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

NCT03731780 | Unknown

• 1 other identifier: 2018cons1
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

caries, prevention, personalized medicine

Outcome Measures

Primary Outcomes (1)

• incidence of new caries lesions

  incidence of new caries lesions

  12 month

Study Arms (3)

Personalized Treatment

EXPERIMENTAL

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

Other: Personalized Treatment

Chlorhexidine and Rremineralization

EXPERIMENTAL

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

Other: Chlorhexidine and Remineralization

Control

ACTIVE COMPARATOR

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

Other: Control

Interventions

Personalized Treatment OTHER

Targeting individual caries risk factors

Personalized Treatment

Chlorhexidine and Remineralization OTHER

chlorhexidine mouth wash and remineralizing agent

Chlorhexidine and Rremineralization

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• High caries risk patients
• years
• Males or Females
• Patients approving to participate in the study -

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Fawzi, PhD

  Cairo University

  STUDY CHAIR

Central Study Contacts

sherif khadr, Msc

CONTACT

+201007777939; sherifkhadr@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 6, 2018
• Study Start: December 1, 2018
• Primary Completion: March 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 7, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12 month after publication , data will be available upon request
• Access Criteria: principal investigator to be contacted by email for data access

Locations

EG (1)