NCT03841825

Brief Summary

This study will compare the use of text message reminders versus multiple in-person sessions of oral hygiene instructions and motivation on improving oral hygiene measurements.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
Last Updated

September 10, 2020

Status Verified

September 1, 2020

Enrollment Period

1.1 years

First QC Date

February 12, 2019

Last Update Submit

September 8, 2020

Conditions

Oral HygieneWhite Spot LesionGingivitis

Outcome Measures

Primary Outcomes (3)

  • Change in 3-item Bleeding Index (BI)

    Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding

    Initial visit to 4 - 6 weeks

  • Change in 3-item Bleeding Index (BI)

    Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding

    4 - 6 weeks to 8 - 12 weeks

  • Change in 3-item Bleeding Index (BI)

    Dental examiner observation of gum bleeding during exam after wires have been removed and participant has brushed teeth. Ratings are 0=absence of bleeding after 30 seconds, 1=bleeding observed after 30 seconds, 2=immediate bleeding

    8 - 12 weeks to 12 - 18 weeks

Secondary Outcomes (6)

  • Change in 5-item Modified Gingival Index (MGI)

    Initial visit to 4 - 6 weeks

  • Change in 5-item Modified Gingival Index (MGI)

    4 - 6 weeks to 8 - 12 weeks

  • Change in 5-item Modified Gingival Index (MGI)

    8 - 12 weeks to 12 - 18 weeks

  • Change in 6 item Plaque index (PI)

    Initial visit to 4 - 6 weeks

  • Change in 6 item Plaque index (PI)

    4 - 6 weeks to 8 - 12 weeks

  • +1 more secondary outcomes

Study Arms (4)

Control

NO INTERVENTION

No messages or oral hygiene instructions

Text message reminders

EXPERIMENTAL

Standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays

Behavioral: Oral hygiene instructions

In-person oral hygiene instructions

ACTIVE COMPARATOR

Oral hygiene instructions and motivation during visit

Behavioral: Oral hygiene instructions

Text messages and in-person instructions

EXPERIMENTAL

standardized text reminding patients to brush their teeth will be sent at 5:15 PM on Thursdays and oral hygiene instructions and motivation during visit

Behavioral: Oral hygiene instructions

Interventions

Oral hygiene instructionsBEHAVIORAL

Oral hygiene instructions and motivation

In-person oral hygiene instructionsText message remindersText messages and in-person instructions

Eligibility Criteria

Age11 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Age 11-20 that have their own mobile device
  • Patients have cellular plan that allows them to receive text messages at no extra cost
  • Patients that will undergo treatment with full fixed appliances

You may not qualify if:

  • patients with significant medical or dental history, including patients with bleeding disorders that would require antibiotic prophylaxis
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Shroff Bhavna, DDS

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2019

First Posted

February 15, 2019

Study Start

February 1, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

September 10, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)