NCT04485312

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2021

Completed
Last Updated

August 13, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

July 18, 2020

Last Update Submit

August 11, 2021

Conditions

Disabilities Multiple

Outcome Measures

Primary Outcomes (1)

  • chance to avoid new caries

    % of the green sector in the cariogram

    10 months

Study Arms (2)

caries preventive protocol

ACTIVE COMPARATOR

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

Behavioral: preventive protocol

chlorhexidine varnish added to the caries preventive protocol

OTHER

chlorhexidine varnish preventive caries protocol for special needs

Behavioral: chlorhexidine added to the preventive protocol

Interventions

preventive protocolBEHAVIORAL

preventive protocol

caries preventive protocol
chlorhexidine added to the preventive protocolBEHAVIORAL

chlorhexidine varnish added to the preventive protocol

chlorhexidine varnish added to the caries preventive protocol

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School

Giza, Egypt

Location

Study Officials

  • katreen tawfik, master

    cairo U

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 18, 2020

First Posted

July 24, 2020

Study Start

July 15, 2020

Primary Completion

July 15, 2021

Study Completion

July 15, 2021

Last Updated

August 13, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

publications in journal

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
1 year
Access Criteria
online access

Locations

EG(1)