Effect of Dental Waterjet on Oral Hygiene for Patients Wi... | NCT03119441

Studies
Effect of Dental Waterjet on Oral Hygiene for Patients With Braces

NCT03119441

Sponsor

Riyadh Colleges of Dentistry and Pharmacy

Status

Unknown status

Last Update Posted

Dec 31, 2018Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Oral Hygiene

Interventions

Dental Water Jet
Dental Floss

Countries

Saudi Arabia

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

Dec 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 13, 2017Actual

Primary Completion Date

Jun 2019Estimated

Completion Date

Oct 2019Estimated

First Submitted Date

Apr 13, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 18, 2017Actual

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

Dec 27, 2018

Last Update Posted Date

Dec 31, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Omar Alkadhi, Assistant professor, Riyadh Colleges of Dentistry and PharmacyPrincipal Investigator

Lead Sponsor

Riyadh Colleges of Dentistry and PharmacyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of this study is to assess the efficacy of dental water jet in plaque removal and gingival health during orthodontic treatment with fixed appliances.

Detailed Description

Subjects will be randomized into two groups. The first group will receive a dental water jet and the second group will receive dental floss. Plaque accumulation using plaque index and gingival health using gingival index will be measured at baseline and after four weeks for each group and then, results will be compared.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dental water jet	Experimental	Dental water jet (Jetpik JP210)	Device: Dental Water Jet
Dental floss	Active Comparator	Dental floss	Device: Dental Floss

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dental Water Jet	Device	Dental Water Jet will be used by subjects to clean their teeth in the interproximal areas.	Dental water jet

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in plaque index	Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque.	At baseline and after 4 weeks.
Change in gingival index	Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding.	At baseline and after 4 weeks.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects having orthodontic fixed appliance.
Subjects aged 12 years old and above who own mobile phones and no mental or physical disabilities.
Subjects willing to comply with given oral hygiene instructions.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Omar H AlKadhi, BDS, MS	Contact	966505154754		omar.alkadhi@riyadh.edu.sa
Osamah M ALMugeiren, BDS, MS	Contact	+966543177777		o.almugeiren@riyadh.edu.sa

Overall Officials

Name	Affiliation	Role
Omar AlKadhi, BDS, MS	Riyadh Colleges of Dentistry and Pharmacy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Riyadh Colleges of Dentistry and Pharmacy	Recruiting	Riyadh	ArRiyadh	11681	Saudi Arabia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

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