Periodontal DiseasesNCT06316505
Oral Photographs of Patients on Oral Hygiene Motivation
A study testing Oral hygiene motivation with individual oral photograps in people with Periodontal Diseases and Motivation, run by Didem OZKAL EMINOGLU at 1 site in Turkey (Türkiye).
Trial summary
Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Motivation, Hygiene
- What is being tested?
- Oral hygiene motivation with individual oral photograps
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 1 Mar 2024
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ranging from 18-60 years;
- a minimum of 12 teeth;
- and being available for the follow-up assessment
- participants were wanted to be right-handers when toothbrushing to standardization.
Who cannot join
- Patients with systemic illnesses or conditions,
- smokers and individuals taking any medication that may affect periodontal health were not included in the study.
- Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Oral Photographs of Patients on Oral Hygiene Motivation Promotes Periodontal Health: a Prospective Randomized Controlled Trial
Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.
Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.
Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters.
Read the detailed description
Maintaining oral health requires a motivated patient. The adherence to a lifelong oral hygiene regimen is significantly influenced by an individual's motivation and manual dexterity. The physician's responsibility in this context is to provide guidance to the patient regarding the appropriate and efficient oral hygiene routine, as well as to motivate their adherence to it. The definition of motivation is to stimulate action or effort towards a particular goal or objective. Motivation is a condition that can be altered in response to external influences and time, rather than being a characteristic. The primary objective of motivation is to enhance persons' knowledge of this matter by highlighting oral health, introducing oral hygiene, and offering information on efficacious mechanical cleaning procedures for eliminating factors that contribute to the deterioration of oral hygiene.
Participants were divided into 2 groups using https://www.randomizer.org/ website:
Control group (CG) (n=28): Conventional oral hygiene education (COHE) [22]
Intervention group (IG) (n=28): In addition to COHE, the following steps were followed:
- Session 1: A photograph was taken before (F1) and after (F2) full-mouth scaling root planing (fmSRP). Then the patient was shown the difference.
- 2nd session: A photograph was taken (F3) and the patient is shown the difference between F1 and F3.
- 3rd session: A photograph was taken (F4) and the patient is shown the difference between F1 - F3 - F4.
- Conditions
- Periodontal Diseases, Motivation, Hygiene
- Being tested
- Oral hygiene motivation with individual oral photograps
- Keywords
- oral hygiene, periodontal health, periodontal indices, motivation, Modified Bass Technique
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral hygiene motivation with individual oral photograpsBehavioural
Oral photograps was taken at control sessions.
| Study group | Role | What they receive |
|---|---|---|
| Control group (CG) | No intervention | Conventional oral hygiene education (COHE) |
| Intervention group (IG) | Experimental | In addition to COHE, oral hygiene motivation with individual oral photographs Receives: Behavioral: Oral hygiene motivation with individual oral photograps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical periodontal parameters / plaque index (PI)
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
Measured: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
Clinical periodontal parameters / gingival index (GI)
The presence and extent of gingival inflammation and bleeding were graded according to the gingival index system. Higher scores mean a worse outcome.
Measured: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
Clinical periodontal parameters / probing pocket depth (PPD).
PPD was measured as the distance between the deepest point of the sulcus and the gingival margin. Higher scores mean a worse outcome.
Measured: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
Clinical periodontal parameters / bleeding on probing (BOP)
The presence of bleeding on probing is considered an objective sign of periodontal inflammation. Higher scores mean a worse outcome.
Measured: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Dec 2023
- Primary completion1 Mar 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem OZKAL EMINOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- DİDEM ÖZKAL EMİNOĞLU, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06316505
- Sponsor's protocol ID
- 11/2023-58
- Status last verified
- Mar 2024
- First submitted
- 12 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ozkal Eminoglu D, Sahin BN, Bicer D, Dal G, Huseynli I, Dadashov A, Betul Dogan D, Kasali K. Using patients' oral photographs for oral hygiene motivation promotes periodontal health: a prospective randomized controlled trial. BMC Oral Health. 2024 Jul 13;24(1):786. doi: 10.1186/s12903-024-04553-7.
PubMed 38997684
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Photographs of Patients on Oral Hygiene Motivation Promotes Periodontal Health: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06316505
- Acronym / sponsor ID
- 11/2023-58
- Conditions
- Periodontal Diseases, Motivation, Hygiene
- Keywords
- oral hygiene, periodontal health, periodontal indices, motivation, Modified Bass Technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Didem OZKAL EMINOGLUUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 18 Mar 2024 (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.
Based on these considerations, this randomized controlled trial aimed to determine the effectiveness of a personalized visual oral health education program in addition to conventional education on oral hygiene by comparing changes in clinical periodontal parameters.
Participants will get conventional oral hygiene education (COHE) with/without visual motivation using self oral photographs of patients.
Researchers will compare Intervention group and control groups on oral hygiene by comparing changes in clinical periodontal parameters.
Detailed description
Maintaining oral health requires a motivated patient. The adherence to a lifelong oral hygiene regimen is significantly influenced by an individual's motivation and manual dexterity. The physician's responsibility in this context is to provide guidance to the patient regarding the appropriate and efficient oral hygiene routine, as well as to motivate their adherence to it. The definition of motivation is to stimulate action or effort towards a particular goal or objective. Motivation is a condition that can be altered in response to external influences and time, rather than being a characteristic. The primary objective of motivation is to enhance persons' knowledge of this matter by highlighting oral health, introducing oral hygiene, and offering information on efficacious mechanical cleaning procedures for eliminating factors that contribute to the deterioration of oral hygiene.
Participants were divided into 2 groups using https://www.randomizer.org/ website:
Control group (CG) (n=28): Conventional oral hygiene education (COHE) [22]
Intervention group (IG) (n=28): In addition to COHE, the following steps were followed:
- Session 1: A photograph was taken before (F1) and after (F2) full-mouth scaling root planing (fmSRP). Then the patient was shown the difference.
- 2nd session: A photograph was taken (F3) and the patient is shown the difference between F1 and F3.
- 3rd session: A photograph was taken (F4) and the patient is shown the difference between F1 - F3 - F4.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group (CG) | No intervention | –Conventional oral hygiene education (COHE) |
| Intervention group (IG) | Experimental | Behavioral: Oral hygiene motivation with individual oral photograpsIn addition to COHE, oral hygiene motivation with individual oral photographs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age ranging from 18-60 years;
- a minimum of 12 teeth;
- and being available for the follow-up assessment
- participants were wanted to be right-handers when toothbrushing to standardization.
Key exclusion criteria (3 listed)
- Patients with systemic illnesses or conditions,
- smokers and individuals taking any medication that may affect periodontal health were not included in the study.
- Individuals who had previously been treated for periodontal disease in the past 6 months were also excluded.
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 |
|---|---|---|
| Oral hygiene motivation with individual oral photograpsOral photograps was taken at control sessions. | Behavioural | Intervention group (IG) |
Primary outcome
Clinical periodontal parameters / plaque index (PI)
Time frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system. Higher scores mean a worse outcome.
Clinical periodontal parameters / gingival index (GI)
Time frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
The presence and extent of gingival inflammation and bleeding were graded according to the gingival index system. Higher scores mean a worse outcome.
Clinical periodontal parameters / probing pocket depth (PPD).
Time frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
PPD was measured as the distance between the deepest point of the sulcus and the gingival margin. Higher scores mean a worse outcome.
Clinical periodontal parameters / bleeding on probing (BOP)
Time frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline
The presence of bleeding on probing is considered an objective sign of periodontal inflammation. Higher scores mean a worse outcome.
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 21 Mar 2024.
- Derived from this study: PubMed 38997684Ozkal Eminoglu D, Sahin BN, Bicer D, Dal G, Huseynli I, Dadashov A, Betul Dogan D, Kasali K. Using patients' oral photographs for oral hygiene motivation promotes periodontal health: a prospective randomized controlled trial. BMC Oral Health. 2024 Jul 13;24(1):786. doi: 10.1186/s12903-024-04553-7.
- Individual participant dataSharing planned: No
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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.
DİDEM ÖZKAL EMİNOĞLU study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral hygiene motivation with individual oral photograps in people with Periodontal Diseases and Motivation, run by Didem OZKAL EMINOGLU at 1 site in Turkey (Türkiye).
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 4 inclusion and 3 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 21 Mar 2024. 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 Turkey (Türkiye). 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?
Clinical periodontal parameters / plaque index (PI) (time frame: T0: baseline, T1: 1 month after baseline, T2: 3 months after baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06316505, which also lists 1 linked publication.
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 21 Mar 2024.