Efficacy of Dental Hygiene Aids in Reducing Gingival Blee... | NCT06554938

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

NCT06554938

Sponsor

Ajman University

Status

Completed

Last Update Posted

Aug 15, 2024Actual

Enrollment

102Actual

Phase

Not Applicable

Conditions

Gingival Bleeding
Dental Plaque

Interventions

water pik
Super floss

Countries

United Arab Emirates

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 10, 2023Actual

Primary Completion Date

Jan 10, 2024Actual

Completion Date

Feb 10, 2024Actual

First Submitted Date

Aug 9, 2024

First Submission Date that Met QC Criteria

Aug 12, 2024

First Posted Date

Aug 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2024

Last Update Posted Date

Aug 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

In order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. The available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation.

Aim: This research aimed to determine whether Waterpik or Superfloss was more effective in lowering the gingival bleeding score and plaque.

Methods: 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
water pik	Device	One side of the mouth was flossed with Super Floss® (Oral-B) and the other with Waterpik®.	water pik

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ajman University		Ajman			United Arab Emirates

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

study protocol, Data and statistical analysis

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)

Time Frame

The data will be shared when requested

Access Criteria

The data can be shared by Email

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005884	Gingival Hemorrhage
D003773	Dental Plaque

Ancestor Terms

ID	Term
D006472	Oral Hemorrhage
D009059	Mouth Diseases
D009057	Stomatognathic Diseases
D005882	Gingival Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003742	Dental Devices, Home Care

Ancestor Terms

ID	Term
D003748	Dental Equipment
D003813	Dentistry
D009910	Oral Hygiene
D011313	Preventive Dentistry

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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.