Efficacy of Dental Hygiene Aids in Reducing Gingival Bleeding and Plaque Among Orthodontic Patients.

NCT06554938 | Completed DMC

• 1 other identifier: D-F-H-31-Oct-ii
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. Both the Waterpik® and the Super-Floss® water flossers are manufactured by Oral-B.

Conditions

Gingival Bleeding; Dental Plaque

Keywords

Dental plaque; Gingival Bleeding; Oral irrigator; waterpik; super floss

Outcome Measures

Primary Outcomes (2)

• Gingival bleeding

  Gingival bleeding scores will be evaluted

  24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention

• Dental plaque

  Dental plaque scores will be evaluated

  24 to 72 hours; 24 hours means at baseline and 72 hours is post intervention

Study Arms (2)

water pik

ACTIVE COMPARATOR

One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.

Device: water pik

Super floss

ACTIVE COMPARATOR

One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.

Device: Super floss

Interventions

water pik DEVICE

One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.

Also known as: oral irrigator

water pik

Super floss DEVICE

One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.

Also known as: Dental floss

Super floss

Eligibility Criteria

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

You may qualify if:

• Participants aged 18-35 years undergoing orthodontic treatment and
• systemically healthy without habits

You may not qualify if:

• Participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent
• missing teeth and
• treated previously for periodontal conditions

Sponsors & Collaborators

• Ajman University: lead

Study Sites (1)

Ajman University

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Gingival Hemorrhage; Dental Plaque

Interventions

Dental Devices, Home Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Randomized trial by lots
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: The study comprised 18-35-year-old girls and boys planning orthodontic treatment. Participants had upper right tooth to lower left molar braces, a pocket depth of 3 mm, and had not flossed in 24 hours. Smoking, periodontal disease, missing teeth, voids between teeth in the arch, and systemic disorders disqualified participants.

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: November 10, 2023
• Primary Completion: January 10, 2024
• Study Completion: February 10, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The data will be shared when requested
• Access Criteria: The data can be shared by Email

Locations

AE (1)