NCT07200063

Brief Summary

This study aims to evaluate and compare the children's acceptance of mouthwash containing silver nanoparticles versus Chlorhexidine.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Jan 2026Jun 2026

First Submitted

Initial submission to the registry

September 9, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 30, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

September 30, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

September 9, 2025

Last Update Submit

September 28, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • children acceptance and compliance

    it will be measured by likert scale (1-5) 1 (strongly disagree) 5 (strongly agree)

    15 days

Secondary Outcomes (3)

  • Gingival health

    15 days

  • plaque thickness at gingival margin

    15 days

  • color stability of composite restoration of anterior teeth

    15 days

Study Arms (3)

use AgNP mouthwash as experimental group

EXPERIMENTAL

nano cure mouthwash

Other: nano silver mouthwash

use hexitol mouthwash (CHX) as experimental group

EXPERIMENTAL
Other: Chlorhexidine mouthwash (0.12%)

orovex mouthwash (CHX) as a comparator group

ACTIVE COMPARATOR
Other: Chlorhexidine mouthwash (0.2%)

Interventions

nano silver mouthwash will reduce the side effect of chlorhexidine and increase acceptance of the mouthwash to patients

use AgNP mouthwash as experimental group

the concentration of chlorhexidine

use hexitol mouthwash (CHX) as experimental group

chlorhexidine mouthwash 0.2% (orovex )

Also known as: orovex
orovex mouthwash (CHX) as a comparator group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged from 6 to 12 in good general health and medically free
  • Cooperative patient who will care about attending the follow-up visit
  • Acceptance of the parents to sign the informed consent

You may not qualify if:

  • Children who are unable to attend the follow-up visit
  • Medically compromised patient
  • Handi-capped patient
  • Parents refuse to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized clinical trail on three groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's student (Dentist)

Study Record Dates

First Submitted

September 9, 2025

First Posted

September 30, 2025

Study Start

January 1, 2026

Primary Completion

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 30, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

cause it a private data and it's mentioned in the informed consent that the data of the participants will be private and not published