NCT06865625

Brief Summary

This study aimed to compare changes in gingival index (GI), plaque index (PI), and gingival bleeding index (GBI) values in fixed orthodontic patients. Participants were classified into two groups based on their oral hygiene: those using the Dentabuddy app for oral hygiene improvement and those receiving assistant-led toothbrushing training. Will the use of the Dentabuddy application lead to differences in oral hygiene levels? Can adolescents effectively utilize the program? Participants will compare the effectiveness of the smartphone application with a group receiving traditional oral hygiene motivation. Participants: Will use the program according to the designated time intervals. Will attend their appointments regularly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2023

Shorter than P25 for all trials

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

August 3, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

March 6, 2025

Last Update Submit

March 7, 2025

Conditions

Keywords

mobile application

Outcome Measures

Primary Outcomes (1)

  • Oral hygiene in patients undergoing fixed orthodontic treatment

    Participants whose oral hygiene scores are monitored through the use of the Dentabuddy application. The Gingival Index (GI) and Plaque Index (PI) are assessed on four surfaces of each tooth (mesial, distal, buccal/labial, and lingual) using a scale from 0 to 3. The total score from all evaluated sites is summed and divided by the total number of teeth to obtain the mean GI and PI values. A reduction in values will indicate a positive outcome of the study.

    From August to November 2023

Study Arms (6)

Dentabuddy Group with good oral hygiene

Individuals with good oral hygiene receiving oral hygiene education through the Dentabuddy application.

Behavioral: mobile application

Dentabuddy Group with fair oral hygiene

Individuals with fair oral hygiene receiving oral hygiene education through the Dentabuddy application.

Behavioral: mobile application

Dentabuddy Group with poor oral hygiene

Individuals with poor oral hygiene receiving oral hygiene education through the Dentabuddy application.

Behavioral: mobile application

Assistant based trainning with good oral hygiene Group

Individuals with good oral hygiene receiving oral hygiene education through traditional methods.

Behavioral: traditional oral hygiene motivation

Assistant based trainning with fair oral hygiene Group

Individuals with fair oral hygiene receiving oral hygiene education through traditional methods.

Behavioral: traditional oral hygiene motivation

Assistant based trainning with poor oral hygiene Group

Individuals with poor oral hygiene receiving oral hygiene education through traditional methods.

Behavioral: traditional oral hygiene motivation

Interventions

In this study, unlike similar studies in the literature, participants were grouped based on their oral hygiene status.

Dentabuddy Group with fair oral hygieneDentabuddy Group with good oral hygieneDentabuddy Group with poor oral hygiene

The group demonstrating the brushing technique on a braces model

Assistant based trainning with fair oral hygiene GroupAssistant based trainning with good oral hygiene GroupAssistant based trainning with poor oral hygiene Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Faculty of Dentistry

You may qualify if:

  • no missing teeth,
  • no systemic diseases or medications,
  • complete permanent dentition,
  • ability to maintain personal oral hygiene

You may not qualify if:

  • dental treatment affecting oral hygiene

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

Location

Related Publications (1)

  • Zotti F, Dalessandri D, Salgarello S, Piancino M, Bonetti S, Visconti L, Paganelli C. Usefulness of an app in improving oral hygiene compliance in adolescent orthodontic patients. Angle Orthod. 2016 Jan;86(1):101-7. doi: 10.2319/010915-19.1. Epub 2015 Mar 23.

Study Officials

  • Seda Sağoğlu, Research Assistant

    Konya Necmettin Erbaka University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator / Research Assistant

Study Record Dates

First Submitted

March 6, 2025

First Posted

March 10, 2025

Study Start

August 3, 2023

Primary Completion

September 3, 2023

Study Completion

November 3, 2023

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations