Comparison Between Interdental Brush and Water Floss on Plaque Accumulation and Gingival Inflammation in Patients Undergoing Fixed Orthodontic Treatment.

NCT07240428 | Completed

• 2 other identifiers: 775/202351/166/2024
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to test the ability of water flosser to remove plaque and reduce gingival inflammation in patients undergoing fixed orthodontic treatment. The main questions it aims to answer are: Does water flosser remove plaque effectively in orthodontic patients? Does water flosser reduce gum inflammation in orthodontic patients? Researchers compared water flosser to interdental brush to see if there is a difference in plaque and inflammation reduction. Participants used interdental brush to clean between their teeth and around brackets in one side of their mouth, and they used water flosser to clean between the teeth and around brackets in the other side. The study lasted for 3 months.

Conditions

Dental Plaque; Gingival Bleeding

Keywords

Interdental cleaning; Interdental brush; Water flosser; Oral hygiene; Orthodontic patients; Gingival inflammation; Plaque index; Oral irrigator

Outcome Measures

Primary Outcomes (1)

• Plaque Index

  Plaque accumulation assessed using the Rustogi Modified Navy Plaque Index (RMNPI) on designated tooth surfaces in the sides assigned to interdental brush and water flosser. The tooth was divided into multiple zones as the following : Whole mouth: areas A,B,C,D,E,F,G and H. Marginal (gum line): areas A,B and C. Interproximal: areas D and F 0 score was given the area where there is no plaque. 1 score was given in the area where there is plaque The minimum plaque score per surface (buccal or lingual) is zero, and the maximum plaque score per surface is 8 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.

  Baseline, 2 weeks, 4 weeks, 2 month and 3 months

Secondary Outcomes (2)

• Gingival Index

  Baseline, 2 weeks, 4 weeks, 2 months ,and 3 months

• Visual Analog Scale (VAS)

  2 Weeks, 4 weeks, 2months, and 3months

Study Arms (2)

Interdental brush

EXPERIMENTAL

Participants used an interdental brush twice daily for interdental cleaning on the assigned side

Device: Interdental brush

Water Flosser

EXPERIMENTAL

Participants used a water flosser twice daily for interdental cleaning on the other assigned side

Device: Water floss

Interventions

Interdental brush DEVICE

Participants used an interdental brush twice daily after toothbrushing on the assigned side. This method was compared to the use of water floss in the contralateral side (split-mouth design).

Interdental brush

Water floss DEVICE

Participants used a water flosser twice daily after toothbrushing on the assigned side. Standard pressure setting and specialized tip were used. This method was compared to the use of an interdental brush in the contralateral quadrants (split-mouth design).

Water Flosser

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with fixed orthodontic appliance upper and lower arches.
• Patients with healthy gingiva with no periodontal disease.
• Patient's orthodontic plan doesn't require extraction of any teeth during the study period.
• Patients should have at least 26 teeth.
• Patients are motivated and able to clean their teeth.
• Patients should not have caries, overhang restorations, crowns, bridges or implants.
• Adults 18-35 years old.

You may not qualify if:

• Smokers.
• Medically compromised patients.
• Pregnant woman.
• Using mouth wash or antibiotic in last 3 months.

Sponsors & Collaborators

• King Abdullah University Hospital: lead
• Jordan University of Science and Technology: collaborator

Study Sites (1)

Jordan University of Science and Technology, Faculty of Dentistry

Irbid, Irbid Governorate, 22110, Jordan

Location

MeSH Terms

Conditions

Dental Plaque; Gingival Hemorrhage; Gingivitis

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Oral Hemorrhage; Mouth Diseases; Gingival Diseases; Periodontal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Lana Bader, DClinDent

  Jordan University of Science and Technology

  STUDY DIRECTOR

• Reem Sami Abed Alhafez, DClinDent Perio

  Jordan University of Science and Technology

  STUDY DIRECTOR

• Ahmad shawqi, MClinDent Perio

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patients know what they're using, but examiner measuring plaque/gingival index is blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr, Assistant Professor

Model Details: Split-mouth randomized controlled clincal trial, where each participant receives one interdental cleaning method for the right side, and another one for the left side.

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: July 1, 2024
• Primary Completion: March 30, 2025
• Study Completion: March 30, 2025
• Last Updated: December 11, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: IPD and supporting documents will be available after publication of the main study results, for a period of one year.
• Access Criteria: Access will be granted to qualified researchers who request the data via email to the principal investigator. Researchers must sign a data use agreement ensuring ethical use, confidentiality, and prohibition of attempts to identify participants.

Locations

JO (1)