- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06010797
Effect of Pre-treatment Photographs on Oral Hygiene Maintenance in Orthodontic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Randomized Controlled Trial Design:
Participants:
Orthodontic patients.
Intervention:
Patients' own pre-treatment dental photographs.
Study group:
Orthodontic patients who are shown dental photographs.
Comparison group:
Orthodontic patients who are not shown dental photographs.
Outcome:
Good oral hygiene measured by plaque index.
Block randomization:
To decrease selection or accidental bias patients were assigned group A or B using block randomization technique. Blocks were created, size of each block was 4 with 2 'A's and 2 'B's. For 2 groups there were 6 possible blocks. From random number table a random sequence of blocks was generated. Patients were then assigned groups according to blocks.
- Subjects:
I. Group 1:
Included 30 patients and these patients were shown full extra-oral and intra-oral photographs.
II. Group 2:
Included 30 patients and these patients were not shown any photographs. All subjects received similar oral hygiene instructions. Those in group A were shown their photographs while those in B were not shown any photographs.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Khyber Pakhtaunkha
-
Abbottabad, Khyber Pakhtaunkha, Pakistan, 22010
- Rehmat Memorial Dental Postgraduate Teaching Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients of both genders
- Between age 13-25 years
Exclusion Criteria:
- Patients with previous orthodontic treatment
- Handicapped patients
- Patients with any systemic disease
- Generalized periodontal disease
- Congenital malformations
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Orthodontic patients who are shown pre-treatment photographs
Group A included 30 patients who were shown their pre-treatment extra-oral and intra-oral photographs.
|
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.
|
|
No Intervention: Orthodontic patients who were not shown pre-treatment photographs
Group B included 30 patients who were not shown their pre-treatment extra-oral and intra-oral photographs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Good oral hygiene measured by plaque index
Time Frame: 3 months
|
Plaque scores at T0 and T1 were compared to assess improvement in oral hygiene
|
3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RehmatMPGDTH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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