Adjunctive Oral Hygiene Aids in Reducing Oral Hygiene Parameters Among Orthodontic Patients

NCT06779279 | Not Yet Recruiting DMC

• 1 other identifier: D-F-H-17-Dec
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Bleeding; Dental Plaque Accumulation

Keywords

waterflosser; superfloss; gingival bleeding; Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Gingival Bleeding

  Gingival bleeding scores will be evaluted 0-no gingival bleeding 1. mild gingival bleeding 2. moderate gingival bleeding 3. spontaneous gingival bleeding

  Through study completion, an average of 1 month

Secondary Outcomes (1)

• Number of Participants with Dental Plaque

  Through study completion, an average of 1 month

Study Arms (2)

water flosser and super flosser

ACTIVE COMPARATOR

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

Device: Water flosser and super flosser

Orthodontic brushes

ACTIVE COMPARATOR

One side of the mouth will be brushed with Orthodontic brushes

Device: Orthodontic brush

Interventions

Water flosser and super flosser DEVICE

Participant will use in one area superfloss and the other area waterfloss

water flosser and super flosser

Orthodontic brush DEVICE

Participant will use orthodontic brush to brush in the upper/lower quadrant

Orthodontic brushes

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

• sudhir rama varma: lead

Study Sites (1)

Ajman university

Ajman, United Arab Emirates

Location

MeSH Terms

Conditions

Gingival Hemorrhage; Dental Plaque

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

Study Officials

• sudhir Rama Varma, MDS

  Ajman University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sudhir Rama Varma, MDS

CONTACT

971506595075; s.varma@ajman.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking done
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR 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: January 10, 2025
• First Posted: January 16, 2025
• Study Start: February 10, 2025
• Primary Completion: March 20, 2025
• Study Completion: March 26, 2025
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Will be available from start of the study till 12 months
• Access Criteria: The data will be shared upon request

Locations

AE (1)