Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04032184

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

66 Participants will be divided into three groups according to the tested regimen (A), where (A1) represents participants exposed to fluoride toothpaste, (A2) represents participants exposed to regimen including fluoride toothpaste and chlorhexidine mouthwash and (A3) represents participants exposed to regimen including fluoride toothpaste, chlorhexidine mouthwash and MI fluoride varnish. The study will be carried over a period of one year, assessment of cariogram will be done in two visits: first visit (baseline: T0) and second visit (after 3 months: T2). In addition assessment of DMF scores will be done in four visits: first visit (baseline: T0), second visit (after 3 months: T1), third visit (after 6 months: T2) and final visit (after 12 months: T3) to obtain the required data

Condition or Disease	Intervention/Treatment	Phase
Prevention of Dental Caries	Other: Fluoride toothpaste Other: fluoride toothpaste and chlorhexidine mouthwash Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Effectiveness of Different Preventive Regimens in Cariogram Parameters and DMF Scores of High Caries Risk Patients: A Randomized Control Trial

Anticipated Study Start Date :

Oct 1, 2019

Anticipated Primary Completion Date :

Oct 1, 2020

Anticipated Study Completion Date :

Nov 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Fluoride toothpaste	Other: Fluoride toothpaste regimen using fluoride toothpaste
Experimental: fluoride toothpaste and chlorhexidine mouthwash	Other: fluoride toothpaste and chlorhexidine mouthwash regimen using fluoride toothpaste and chlorhexidine mouthwash
Experimental: fluoride toothpaste, chlorhexidine mouthwash, MI varnish	Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Arm

Intervention/Treatment

Active Comparator: Fluoride toothpaste

Other: Fluoride toothpaste

regimen using fluoride toothpaste

Experimental: fluoride toothpaste and chlorhexidine mouthwash

Other: fluoride toothpaste and chlorhexidine mouthwash

regimen using fluoride toothpaste and chlorhexidine mouthwash

Experimental: fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Other: fluoride toothpaste, chlorhexidine mouthwash, MI varnish

regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish

Outcome Measures

Primary Outcome Measures

Caries Risk Assessment [an average 3 months]
will be evaluated by cariogram

Secondary Outcome Measures

DMF scores [an average of 12 months]
will be evaluated by ICDAS

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age range 20-50 years
High caries risk patients defined according to cariogram caries risk assessment model
On non-cariogenic diet
High plaque index
Systematically healthy
No orthodontic or prosthodontic appliance

Exclusion Criteria:

Age range less than 20 or more than 50 years
Low or moderate caries risk patients according to cariogram
Patients with a compromised medical history
Cariogenic diet patient
Participants with a history of allergy to any of the drugs or chemicals used in the study
Patients on any antibiotics during the past month

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Howaida Fakhry Fouad	Giza	Other	Egypt	8655

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Howaida Fakhry Fouad, Resident of conservative departement , Faculty of Oral and Dental Medicine, Cairo university 2012, Cairo University

ClinicalTrials.gov Identifier:

NCT04032184

Other Study ID Numbers:

1234567

First Posted:

Jul 25, 2019

Last Update Posted:

Jul 25, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

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

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

Additional relevant MeSH terms:

Dental Caries

Chlorhexidine

Chlorhexidine gluconate

Fluorides

Study Results

No Results Posted as of Jul 25, 2019