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

NCT ID: NCT07240428

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2025-03-30

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.

Detailed Description

• Study design This is a randomized controlled single blinded clinical trial, with split mouth design.
• Sample size Forty seven subjects with fixed orthodontic appliance were recruited from patients attending dental teaching clinics at Jordan University of Science and Technology. The age range was between 18 and 35 years. They were randomly assigned to use interdental brush on one side of the mouth, and water floss on the other side in a split mouth design.

The study lasted for 3 months.

1. Inclusion criteria:

1. Patients with fixed orthodontic appliance in the upper and lower arches. 2. Patients with healthy gingiva with no periodontal disease. 3. Patient's orthodontic plan doesn't require extraction of any teeth during the study period. .

4. Patients should have at least 26 teeth. 5. Patients are motivated and able to clean their teeth. 6. Patients should not have caries, overhang restorations, crowns, bridges or implants 7. Adults 18-35 years old.

2. Exclusion criteria:

1. Smokers 2. Medically compromised patients 3. Pregnant woman.

• Ethical considerations The study was approved by the Institutional Review Board (IRB) of Jordan University of Science and Technology (51/166/2024). All participating patients were informed of the study's purpose, objectives, and methods. They all provided a written informed consent before data collection.
• Data collection:

1. Patients randomly used water floss on one side of the mouth , and the interdental brush on the other side.

2. Randomization was used to assign the intervention to either the left or right side of the mouth.

The following will be assessed

1- Plaque score using Rustogi modified navy plaque index for buccal and lingual surfaces, where the tooth was divided into multiple zones as the following :

The divided zones are:

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 Intraoral photos using professional camera were taken for all teeth and all surfaces to record the plaque score.

2. gingival inflammation was recorded using gingival index at six sites per tooth (distobuccal, midbuccal, mesiobuccal, distolingual/palatal, midlingual/palatal, mesiolingual/palatal) as follows : 0= Normal gingiva.

1. Mild inflammation - slight change in colour and slight edema but no bleeding on probing.

2. Moderate inflammation - redness, edema and glazing, bleeding on probing.

3. Severe inflammation - marked redness and edema, ulceration with tendency for spontaneous bleeding.

3.Visual Analog Scale (VAS) visual analog scale from 0 - 10 (0 - unsatisfied, uncomfortable, or difficult to use, 10 -very satisfied, comfortable, and easy to use) in each visit was taken.

Randomization and Blinding Independent of the clinical assessment, a third-party dentist used a computer-generated random number sequence to determine which side of each patient's mouth will be cleaned by interdental brush and which side will be cleaned by the oral irrigator. While participants were aware of which device they were using on each side, the examiner who performed the clinical examinations was blinded.

• Adverse events monitoring: Participants were monitored for adverse events during the study period such as gingival trauma, sensitivity, recession, tooth or restoration damage.

Conditions

Dental Plaque; Gingival Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Interdental brush

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

Group Type: EXPERIMENTAL

Interdental brush

Intervention Type: 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).

Water Flosser

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

Group Type: EXPERIMENTAL

Water floss

Intervention Type: 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).

Interventions

Interdental brush

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).

Intervention Type: DEVICE

Water floss

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Abdullah University Hospital

OTHER

Sponsor Role: lead

Jordan University of Science and Technology

OTHER

Sponsor Role: collaborator

Responsible Party

Lana Bader

Dr, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lana Bader, DClinDent

Role: STUDY_DIRECTOR

Jordan University of Science and Technology

Reem Sami Abed Alhafez, DClinDent Perio

Role: STUDY_DIRECTOR

Jordan University of Science and Technology

Ahmad shawqi, MClinDent Perio

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Jordan University of Science and Technology, Faculty of Dentistry

Irbid, Irbid Governorate, Jordan

Countries

Jordan

Other Identifiers

51/166/2024

Identifier Type: OTHER

Identifier Source: secondary_id

775/2023

Identifier Type: -

Identifier Source: org_study_id