EFFECTIVENESS of WATER FLOSS in PLAQUE REMOVAL and PREVENTION of WHITE SPOT LESIONS in ORTHODONTIC PATIENTS: a RANDOMISED CONTROLLED CLINICAL TRIAL
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Malaya
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- White spot lesion
Study Overview
Brief Summary
This clinical trial aims to learn if water floss is as efficient as other interdental cleaning tools and can prevent plaque accumulation and white spot lesions (WSLs) in orthodontic patients. It will also assess the impact of water floss on gingival health. The main questions it aims to answer are:
- Which interdental cleaning tools reduce plaque accumulation and improve gingival health in orthodontic patients?
- Which interdental cleaning tools lower the incidence of white spot lesions compared to conventional oral hygiene practices? Researchers will compare the oral health of Orthodontic patients' using different interdental cleaning tools to evaluate their effectiveness in improving oral health outcomes.
Participants will:
-
Be assigned to one of two groups:
-
Intervention group: instructed to use water flossing in their oral hygiene routine.
-
Control group: instructed to use dental floss and interdental brush in their oral hygiene routine.
-
Participate for 8 months, with clinical assessments for plaque and gingival health and photographic documentation for WSLs at baseline (T0), and at 2-month intervals (T1, T2, T3, and T4).
Detailed Description
This clinical trial aims to learn if water floss is as efficient as other interdental cleaning tools and can prevent plaque accumulation and white spot lesions (WSLs) in orthodontic patients. It will also assess the impact of water floss on gingival health. The main questions it aims to answer are:
- Which interdental cleaning tools reduce plaque accumulation and improve gingival health in orthodontic patients?
- Which interdental cleaning tools lower the incidence of white spot lesions compared to conventional oral hygiene practices? Researchers will compare the oral health of Orthodontic patients' using different interdental cleaning tools to evaluate their effectiveness in improving oral health outcomes.
Participants will:
-
Be assigned to one of two groups:
-
Intervention group: instructed to use water flossing in their oral hygiene routine.
-
Control group: instructed to use dental floss and interdental brush in their oral hygiene routine.
-
Participate for 8 months, with clinical assessments for plaque and gingival health and photographic documentation for WSLs at baseline (T0), and at 2-month intervals (T1, T2, T3, and T4).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Mild to moderate crowding upper and lower arch 18 years old and above Patients with BPE score 0/1 Stay in areas with the same concentration of water fluoridation No history of orthodontic treatment before Able to read and understand in English or Bahasa Melayu Fit and healthy Patients with upper and lower fixed appliance
Exclusion Criteria
- •Severe crowding Less than 18 years old Patients with BPE score more than 2 Patients with systemic disease and syndromic Syndromic patients (eg; Cleft lip and palate) Unable to read and understand in English or Bahasa Melayu Clinically missing teeth (impacted/congenitally missing) Patients with segmental fixed appliances in single or both arches.
Arms & Interventions
Groups of orthodontic patients with experimental interdental cleaning tools ( Water Flosser )
Groups of orthodontic patients with Water Flosser
Intervention: water flosser (Device)
Groups of orthodontic patients with controlled interdental cleaning tools
Groups of orthodontic patients with controlled interdental cleaning tools ( dental floss and interdental brush)
Outcomes
Primary Outcomes
White spot lesion
Time Frame: From enrollment to the end of study at 8 months
White spot lesion assessment using the Enamel Decalcification Index (EDI) by observing the clinical photos
Dental plaque
Time Frame: From enrollment to the end of study at 8 months
Dental plaque using the Orthodontic Plaque Index (OPI)
Gingival health
Time Frame: From enrollment to the end of study at 8 months
Gingival health assessment using the gingival index
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr Afif Shafie bin Abd Samad
DR
University of Malaya