NCT06010797

Brief Summary

Dental photography is an essential component of orthodontic treatment. Photographs enable the clinician to keep record of different stages of treatment. Other uses are for treatment planning, communicating with the patients and other specialists, comparison of pre-treatment and post-treatment changes, for research purpose and also for patient's motivation. Images captured before, during and after treatment provide legal protection when necessary. In the orthodontic discipline, at least three extra-oral and five intra-oral photographs are recommended. Extra-oral photographs should correctly reflect patient's appearance and intra-oral photographs should show complete dentition and occlusion. Oral hygiene is controlled by the patient during orthodontic treatment which requires proper motivation. Motivational methods are classified as chair-side education, message reminders, behavioral modification and Hawthorne effect. Patients' motivation plays an important role in maintaining favorable oral hygiene. A number of studies have shown the effect of motivational methods on oral hygiene improvement. In one of these studies, 80 patients who needed orthodontic treatment were selected and randomly distributed into two equal groups as control group and study group. The study group patients were included in a Whatsapp where they shared their own photographs (selfies) and received text messages, while the control group patients were not included in any Whatsapp group. Baseline PI scoring was 0.48(0.34) in control group and 0.41(0.32) in study group, After 3 months PI scoring was 1.72(0.33) in control group and 1.68(0.40) in study group. Results showed that sharing of selfies improves oral hygiene compliance in Orthodontic patients. The purpose of this study was to determine probable effect of pre-treatment photographs on oral hygiene maintenance in orthodontic patients. To our knowledge no such study has been done previously. This would help us in making patients understand the importance of oral hygiene maintenance. The results will also be used by other practitioners.

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 not_applicable

Timeline
Completed

Started Aug 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 10, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 25, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 20, 2023

Last Update Submit

August 29, 2023

Conditions

Keywords

Oral hygienePhotographsDentalOrthodonticsPeriodontitisGingivitisIndex

Outcome Measures

Primary Outcomes (1)

  • Good oral hygiene measured by plaque index

    Plaque scores at T0 and T1 were compared to assess improvement in oral hygiene

    3 months

Study Arms (2)

Orthodontic patients who are shown pre-treatment photographs

EXPERIMENTAL

Group A included 30 patients who were shown their pre-treatment extra-oral and intra-oral photographs.

Device: Showing Pre-treatment photographs of the patient

Orthodontic patients who were not shown pre-treatment photographs

NO INTERVENTION

Group B included 30 patients who were not shown their pre-treatment extra-oral and intra-oral photographs.

Interventions

Extra-oral and intra-oral dental photographs of patients were taken before starting Orthodontic treatment. Experimental group were shown their photographs while control group were not shown their photographs.

Orthodontic patients who are shown pre-treatment photographs

Eligibility Criteria

Age13 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients of both genders
  • Between age 13-25 years

You may not qualify if:

  • Patients with previous orthodontic treatment
  • Handicapped patients
  • Patients with any systemic disease
  • Generalized periodontal disease
  • Congenital malformations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehmat Memorial Dental Postgraduate Teaching Hospital

Abbottabad, Khyber Pakhtaunkha, 22010, Pakistan

Location

MeSH Terms

Conditions

PeriodontitisGingivitisErythema Multiforme

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesErythemaSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Vesiculobullous

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
It was a double blinded randomized controlled trial. Patients and the investigator recording indices were blinded.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 20, 2023

First Posted

August 25, 2023

Study Start

August 10, 2020

Primary Completion

July 4, 2021

Study Completion

July 4, 2021

Last Updated

September 5, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations