EFFECTIVENESS of WATER FLOSS in PLAQUE REMOVAL and PREVENTION of WHITE SPOT LESIONS in ORTHODONTIC PATIENTS: a RANDOMISED CONTROLLED CLINICAL TRIAL

NCT06752291 | Active Not Recruiting

• 2 other identifiers: DF CD 2424/0060 (P)UMG052E-2024
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

White Spot Lesion of Tooth; Gingival Inflammation; Gingival Bleeding; Dental Plaque

Keywords

water flosser; white spot lesion

Outcome Measures

Primary Outcomes (3)

• White spot lesion

  White spot lesion assessment using the Enamel Decalcification Index (EDI) by observing the clinical photos

  From enrollment to the end of study at 8 months

• Dental plaque

  Dental plaque using the Orthodontic Plaque Index (OPI)

  From enrollment to the end of study at 8 months

• Gingival health

  Gingival health assessment using the gingival index

  From enrollment to the end of study at 8 months

Study Arms (2)

Groups of orthodontic patients with experimental interdental cleaning tools ( Water Flosser )

EXPERIMENTAL

Groups of orthodontic patients with Water Flosser

Device: water flosser

Groups of orthodontic patients with controlled interdental cleaning tools

NO INTERVENTION

Groups of orthodontic patients with controlled interdental cleaning tools ( dental floss and interdental brush)

Interventions

water flosser DEVICE

A water flosser will be provided for use throughout the study, with participants instructed to use it once daily, specifically at the end of the day before bedtime.

Groups of orthodontic patients with experimental interdental cleaning tools ( Water Flosser )

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, Universiti Malaya, Kuala Lumpur, Kuala Lumpur 50603

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (9)

• Patano A, Malcangi G, Sardano R, Mastrodonato A, Garofoli G, Mancini A, Inchingolo AD, Di Venere D, Inchingolo F, Dipalma G, Inchingolo AM. White Spots: Prevention in Orthodontics-Systematic Review of the Literature. Int J Environ Res Public Health. 2023 Apr 21;20(8):5608. doi: 10.3390/ijerph20085608.

  PMID: 37107890 BACKGROUND

• Quaranta A, Marchisio O, D'isidoro O, Genovesi AM, Covani U. Single-blind randomized clinical trial on the efficacy of an interdental cleaning device in orthodontic patients. Minerva Stomatol. 2018 Aug;67(4):141-147. doi: 10.23736/S0026-4970.18.04104-3. Epub 2018 Feb 13.

  PMID: 29495655 BACKGROUND

• Sarner B, Birkhed D, Andersson P, Lingstrom P. Recommendations by dental staff and use of toothpicks, dental floss and interdental brushes for approximal cleaning in an adult Swedish population. Oral Health Prev Dent. 2010;8(2):185-94.

  PMID: 20589254 BACKGROUND

• Sawan N, Ben Gassem A, Alkhayyal F, Albakri A, Al-Muhareb N, Alsagob E. Effectiveness of Super Floss and Water Flosser in Plaque Removal for Patients Undergoing Orthodontic Treatment: A Randomized Controlled Trial. Int J Dent. 2022 Aug 31;2022:1344258. doi: 10.1155/2022/1344258. eCollection 2022.

  PMID: 36090126 BACKGROUND

• Sharab L, Loss C, Jensen D, Kluemper GT, Alotaibi M, Nagaoka H. Prevalence of white spot lesions and gingival index during orthodontic treatment in an academic setting. Am J Orthod Dentofacial Orthop. 2023 Jun;163(6):835-842. doi: 10.1016/j.ajodo.2022.08.023. Epub 2023 Jan 29.

  PMID: 36720655 BACKGROUND

• Smith AJ, Moretti AJ, Brame J, Wilder RS. Knowledge, attitudes and behaviours of patients regarding interdental deplaquing devices: A mixed-methods study. Int J Dent Hyg. 2019 Nov;17(4):369-380. doi: 10.1111/idh.12410. Epub 2019 Jun 27.

  PMID: 31152632 BACKGROUND

• Sundararaj D, Venkatachalapathy S, Tandon A, Pereira A. Critical evaluation of incidence and prevalence of white spot lesions during fixed orthodontic appliance treatment: A meta-analysis. J Int Soc Prev Community Dent. 2015 Nov-Dec;5(6):433-9. doi: 10.4103/2231-0762.167719.

  PMID: 26759794 BACKGROUND

• Vivaldi-Rodrigues G, Demito CF, Bowman SJ, Ramos AL. The effectiveness of a fluoride varnish in preventing the development of white spot lesions. World J Orthod. 2006 Summer;7(2):138-44.

  PMID: 16779972 BACKGROUND

• Yazarloo S, Arab S, Mirhashemi AH, Gholamrezayi E. Systematic review of preventive and treatment measures regarding orthodontically induced white spot lesions. Dent Med Probl. 2023 Jul-Sep;60(3):527-535. doi: 10.17219/dmp/140964.

  PMID: 37815515 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Gingival Hemorrhage; Dental Plaque

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: December 30, 2024
• Study Start: April 1, 2024
• Primary Completion: October 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)