Oral HygieneNCT06010797
Effect of Pre-treatment Photographs on Oral Hygiene Maintenance in Orthodontic Patients
A study testing Showing Pre-treatment photographs of the patient in people with Oral Hygiene and Photographs, run by Rehmat Memorial Post Graduate Dental Teaching Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Photographs
- What is being tested?
- Showing Pre-treatment photographs of the patient
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2020to 4 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients of both genders
- Between age 13-25 years
Who cannot join
- Patients with previous orthodontic treatment
- Handicapped patients
- Patients with any systemic disease
- Generalized periodontal disease
- Congenital malformations
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehmat Memorial Dental Postgraduate Teaching Hospital
Abbottabad, Khyber Pakhtaunkha, 22010
About this study
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.
Read the 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:
- 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.
- Conditions
- Oral Hygiene, Photographs
- Being tested
- Showing Pre-treatment photographs of the patient
- Keywords
- Oral hygiene, Photographs, Dental, Orthodontics, Periodontitis, Gingivitis, Index
- Medical subject headings
- Periodontitis, Gingivitis, Erythema Multiforme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Showing Pre-treatment photographs of the patientDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Good oral hygiene measured by plaque index
Plaque scores at T0 and T1 were compared to assess improvement in oral hygiene
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start10 Aug 2020
- Primary completion4 Jul 2021
- Study completion4 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rehmat Memorial Post Graduate Dental Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eizza Niaz, Rehmat Memorial Post Graduate Dental Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010797
- Sponsor's protocol ID
- RehmatMPGDTH
- Status last verified
- Aug 2023
- First submitted
- 20 Aug 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pre-treatment Photographs on Oral Hygiene Maintenance in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT06010797
- Acronym / sponsor ID
- RehmatMPGDTH
- Conditions
- Oral Hygiene, Photographs
- Keywords
- Oral hygiene, Photographs, Dental, Orthodontics, Periodontitis, Gingivitis, Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rehmat Memorial Post Graduate Dental Teaching HospitalUniversity, hospital or other
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 4 Jul 2021 (actual)
- Study completion
- 4 Jul 2021 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthodontic patients who are shown pre-treatment photographs | Experimental | Device: Showing Pre-treatment photographs of the patientGroup A included 30 patients who were shown their pre-treatment extra-oral and intra-oral photographs. |
| 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. |
Who may qualify
- Ages
- 13 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients of both genders
- Between age 13-25 years
Key exclusion criteria (5 listed)
- Patients with previous orthodontic treatment
- Handicapped patients
- Patients with any systemic disease
- Generalized periodontal disease
- Congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Showing Pre-treatment photographs of the patientExtra-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. | Device | Orthodontic patients who are shown pre-treatment photographs |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Oral Hygiene
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Not yet recruiting
Game-based Oral Health Promotion
Oral Hygiene
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Showing Pre-treatment photographs of the patient in people with Oral Hygiene and Photographs, run by Rehmat Memorial Post Graduate Dental Teaching Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Good oral hygiene measured by plaque index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2023.