The Effects of Using Water Flosser Versus Interdental Brush on Gingival Health in Patients With Mandibular Bonded Retainer

NCT07054203 | Completed DMC

• 1 other identifier: 2023-8799-26054
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aimed to investigate and compare the effects of employing a water flosser versus an interdental brush on the gingival health of individuals with mandibular bonded retainers. The study recognized the significance of oral hygiene for individuals with such retainers, as they can pose challenges in maintaining optimal gum health due to their intricate structure. Participants were randomly allocated to either the water flosser group or the interdental brush group, and their gingival health was monitored over the course of the trial. By evaluating key indicators of gingival health, such as plaque accumulation, bleeding, and inflammation, this study sought to shed light on the relative effectiveness of these two oral hygiene methods. The project's findings are anticipated to provide crucial insights into the most suitable and efficacious approach for individuals with mandibular bonded retainers, ultimately contributing to improved oral health outcomes and enhanced patient care. This research not only addresses a practical concern in dental care but also contributes to the broader understanding of oral hygiene strategies for patients with specialized orthodontic devices.

Conditions

Gingival Health

Keywords

fixed orthodontic treatment; gingival health; mandibular bonded retainer; water flosser; interdental brushes

Outcome Measures

Primary Outcomes (1)

• Mean plaque scores

  A randomized controlled trial will be carried out to compare the effects of water flosser versus interdental brush in improving gingival health in patients with mandibular permanent retainers by detecting differences in debris accumulation, plaque and calculus formation, and signs of gingival inflammation such as gingival bleeding. For this we will divide our study participants into two groups, they will be randomly allocated in Group 1: Water flosser or Group 2: Interdental brush. Both groups will undergo retention procedure as per standard protocol by bonding of retainer on lingual surfaces of lower teeth. Plaque scores will be measured thrice, once immediately after debonding followed by three months and six months after debonding using periodontal probe.

  6 months

Study Arms (2)

Water Flosser

EXPERIMENTAL

This arm assigns participants to a powered Water Flosser (e.g., Waterpik Aquarius) because hydrodynamic shear forces can penetrate subgingival niches. Each participant receives standardized instruction plus a live demonstration; they then perform once-daily full-mouth irrigation for six months in addition to conventional tooth-brushing.

Device: Interdental Brush

Interdental Brush

ACTIVE COMPARATOR

Participants allocated to this arm receive Interdental Brushes matched to embrasure size. They are instructed to perform once-daily mechanical cleaning of every interproximal space for six months, again paired with twice-daily manual tooth-brushing

Device: Water Flosser

Interventions

Water Flosser DEVICE

Participants in this Arm used a powered oral irrigator delivering a pulsed water stream at 50-90 psi. The intervention consisted of once-daily full-mouth irrigation, added to routine tooth brushing, for a duration of six months.

Interdental Brush

Interdental Brush DEVICE

Participants in this Arm used cylindrical, color-coded interdental brushes matched to individual embrasure sizes. The intervention involved once-daily cleaning of all interproximal spaces for six months, in addition to routine twice-daily tooth brushing.

Water Flosser

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing fixed orthodontic treatment requiring bonded retention
• All patients who will sign the informed consent form

You may not qualify if:

• Patients with systemic diseases or multiple co-morbid such as diabetes, blood dyscrasias, etc.
• Patients with any previous history of periodontal surgery
• Patients with uncontrolled periodontal disease
• Pregnant women or lactating mothers

Sponsors & Collaborators

• Aga Khan University: lead

Study Sites (1)

Aga Khan University Hospital

Karachi, Sindh, 74800, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 8, 2025
• Study Start: July 14, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 10, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)