NCT07469839

Brief Summary

The goal of this Randomized Clinical Trial is to compare the effectiveness of water flossing versus regular flossing in reducing dental plaque in children aged 10-15 years. The main question is the water flossing equal or more effective than regular flossing. Each participant will use both interdental cleaning methods, water flossing and regular flossing, in two separate visits and the plaque Index (PI) will be recorded. Regular Dental Floss Group: Unflavored, unwaxed regular dental floss (Oral-B, USA), or Water Flosser: Water flosser (Waterpik Cordless Plus Water Flosser, USA)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

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

November 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 26, 2026

Last Update Submit

March 16, 2026

Conditions

Keywords

Water flossingpediatric dentistryrandomized clinical trialdental plaqueoral hygieneregular flossing

Outcome Measures

Primary Outcomes (1)

  • Plaque Index (PI)

    to assess the Plaque Index (PI) using the criteria of Silness and Löe (1964).

    16 days, 1st visit followed by 14 days washout period then 2nd visit

Study Arms (2)

Regular Dental Floss

EXPERIMENTAL

Unflavored, unwaxed regular dental floss (Oral-B, USA)

Device: Unflavored, unwaxed regular dental floss (Oral-B, USA)Device: Water flosser (Waterpik Cordless Plus Water Flosser, USA)

Water Flosser

EXPERIMENTAL

Water flosser (Cordless Plus Water Flosser, USA)

Device: Unflavored, unwaxed regular dental floss (Oral-B, USA)Device: Water flosser (Waterpik Cordless Plus Water Flosser, USA)

Interventions

Plaque removal

Also known as: Group A
Regular Dental FlossWater Flosser

Plaque removal

Regular Dental FlossWater Flosser

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Children with fewer than four posterior proximal contacts were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz University- Peditaric dentistry clinics

Jeddah, Saudi Arabia

Location

Related Publications (1)

  • Abdellatif H, Alnaeimi N, Alruwais H, Aldajan R, Hebbal MI. Comparison between water flosser and regular floss in the efficacy of plaque removal in patients after single use. Saudi Dent J. 2021 Jul;33(5):256-259. doi: 10.1016/j.sdentj.2021.03.005. Epub 2021 Mar 31.

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assisstant Professor

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 13, 2026

Study Start

November 1, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Due to privacy

Locations