Chance to Avoid New Caries by Adding Chlorhexidine to the Preventive Protocol in Adolescent Special Needs

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04485312

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Adolescent Special need individuals are most need of easy forms of antibacterial agents, so in this study, using chemotherapeutic agents like the newly introduced varnish containing chlorhexidine seems to be a quite promising tool for local delivery to patients with special needs . Chlorhexidine is a wide spectrum very effective bactericidal used for years against the oral flora while fluorides are well known with their antibacterial ability. This may be an excellent way to reduce the risk assessment in adolescent special needs patients.

Condition or Disease	Intervention/Treatment	Phase
Disabilities Multiple	Behavioral: preventive protocol Behavioral: chlorhexidine added to the preventive protocol	N/A

Detailed Description

Participants will be divided into two groups according to the tested regimen, where (A1) represents participants exposed to risk based conventional protocol, (A2) represents participants exposed to chlorhexidine containing varnish and risk based conventional preventive protocol. The study will be carried over a period of 10 months (one academic year), the study will be divided into three phases Phase I: Information of the Cariogram parameters (caries experience, diet content, diet frequency, plaque amount, mutans streptococci, fluoride program, saliva secretion and saliva buffer capacity) will be collected, which will be used to generate the individual caries profile, based on which the participants will be divided into 2 risks groups. Phase II: Risk based preventive program will be implemented including the restorative part. Phase III: At the end of 10 months, caries profile will be generated again

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Chance to Avoid New Caries by Adding Chlorhexidine Containing Chemotherapeutic Agent to the Conventional Preventive Protocol for Patients With Special Needs

Actual Study Start Date :

Jul 15, 2020

Actual Primary Completion Date :

Jul 15, 2021

Actual Study Completion Date :

Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: caries preventive protocol preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)	Behavioral: preventive protocol preventive protocol
Other: chlorhexidine varnish added to the caries preventive protocol chlorhexidine varnish preventive caries protocol for special needs	Behavioral: chlorhexidine added to the preventive protocol chlorhexidine varnish added to the preventive protocol

Arm

Intervention/Treatment

Active Comparator: caries preventive protocol

preventive protocol for special needs ( tooth brushing , topical fluoride and mouth wash)

Behavioral: preventive protocol

preventive protocol

Other: chlorhexidine varnish added to the caries preventive protocol

chlorhexidine varnish preventive caries protocol for special needs

Behavioral: chlorhexidine added to the preventive protocol

chlorhexidine varnish added to the preventive protocol

Outcome Measures

Primary Outcome Measures

chance to avoid new caries [10 months]
% of the green sector in the cariogram

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of disability like : autism and down syndrome.
Must be able to open his/her mouth for varnish application

Exclusion Criteria:

systemically unhealthy patients with fetal diseases
Age below 13 and above 18

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School	Giza		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: katreen tawfik, master, cairo U

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Katreen Tawfik, principal investigator, Cairo University

ClinicalTrials.gov Identifier:

NCT04485312

Other Study ID Numbers:

abcxyz

First Posted:

Jul 24, 2020

Last Update Posted:

Aug 13, 2021

Last Verified:

Aug 1, 2021

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:

Additional relevant MeSH terms:

Chlorhexidine

Study Results

No Results Posted as of Aug 13, 2021