Plaque-Induced GingivitisNCT07479706
Impact of Oral Hygiene Instruction in Gingivitis Patients
A study testing video-based oral hygiene instruction and Model-based oral hygiene instruction in people with Plaque-Induced Gingivitis, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to comparatively evaluate the effectiveness of two different oral hygiene instruction methods given in addition to Phase 1 periodontal treatment in patients diagnosed with gingivitis, on periodontal clinical parameters and patient awareness scores, and to examine the relationship between the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plaque-Induced Gingivitis
- What is being tested?
- video-based oral hygiene instruction and Model-based oral hygiene instruction
- 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
- 0 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2024to 1 Feb 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having an average whole-mouth gingival index (GI) score above 2.0
Who cannot join
- Individuals with an average gingival index below 2.0,
- Individuals with periodontal pockets deeper than 4 mm in one or more areas,
- Individuals with fixed prosthetic restorations in any tooth,
- Individuals who have received periodontal treatment within the last 6 months,
- Individuals who smoke or use similar tobacco products,
- Individuals who have used antibiotics for any reason within the last 3 months,
Show all 9Show fewer
- Individuals who are unable to perform adequate oral hygiene practices,
- Individuals who have lost 5 or more teeth other than wisdom teeth,
- Individuals under 18 or over 65 years of age were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Denstistry Department of Periodontology
Ankara, 06560
About this study
Official title: Impact of Video-Based Versus Model-Based Oral Hygiene Instruction on Clinical Parameters and Disease Awareness in Gingivitis Patients: A Randomized Clinical Trial
The aim of this study is to comparatively evaluate the effectiveness of two different oral hygiene instruction methods given in addition to Phase 1 periodontal treatment in patients diagnosed with gingivitis, on periodontal clinical parameters and patient awareness scores, and to examine the relationship between the change in awareness score and clinical improvement. The main question it aims to answer is:
Is video-based visual oral hygiene training as memorable and motivating as hands-on training using a model?
Read more
A total of 80 patients who were diagnosed with gingivitis were included in the study. The oral health of the patients was assessed by a researcher using periodontal indices, and patients were asked to complete a 10-question questionnaire to assess their own periodontal health and oral hygiene status (T0). Following baseline measurements, all patients received standard Phase 1 periodontal treatment by another clinician. At the end of treatment, patients were randomly assigned to two different oral hygiene instruction (OHI) groups of 40 each:
Group 1 (Video Group): Oral hygiene instruction in this group was provided through standard video content; Group 2 (Model Group): Oral hygiene instruction was given through practical demonstration using three-dimensional dental models.
Patients were called for a follow-up appointment one month after the Phase 1 periodontal treatment (T1). All initial clinical indices were measured and recorded, and patients were asked to complete the same awareness questionnaire again.
Read the detailed description
The periodontal indices to be evaluated at time points T0 and T1 in the study was determined as follows:
- Plaque index (Löe \& Silness) to evaluate the individual oral hygiene performance of the patient. Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
- Gingival index (Sillness \& Löe) evaluates the inflammatory response of the gingiva due to plaque accumulation. In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
- Pocket depth measurement on probing to assess the amount of destruction caused by periodontal disease at the base of the gingival groove. It is a measurement that gives a numerical value in millimeters, and as the measured number increases, it indicates greater tissue destruction caused by periodontal disease and a deeper periodontal pocket.
- Bleeding on probing is used to determine whether periodontal disease is in an active destructive phase at the base of the gingival groove. The bleeding on probing index is used to detect and record bleeding that may occur upon contact of the probe with the base of the periodontal pocket, and is scored as "present" or "absent".
The numerical value recorded as the awareness score is obtained from the patients' answers to 10 questions in the survey. Each question is answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum. As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
Periodontal measurements and patient awareness questionnaire scores from both time points were recorded, and pairwise comparisons, analysis of covariance, and correlation analyses were conducted to analyze the observed change and evaluate the response of the two groups to treatment.
- Conditions
- Plaque-Induced Gingivitis
- Being tested
- video-based oral hygiene instruction, Model-based oral hygiene instruction
- Keywords
- Gingivitis, Dental plaque, Oral hygiene instruction, Disease awareness
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
video-based oral hygiene instructionBehavioural
Following standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received standardized oral hygiene instruction via a video presentation. The video demonstrated proper tooth brushing and interdental cleaning techniques. A link to the video was also provided to the patients for at-home reinforcement.
Model-based oral hygiene instructionBehavioural
Following standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received practical oral hygiene instruction demonstrated on a 3D dental model by the researcher. The demonstration included proper tooth brushing and interdental cleaning techniques.
| Study group | Role | What they receive |
|---|---|---|
| video group | Experimental | Phase 1 periodontal therapy + Video-based oral hygiene instruction Receives: Behavioral: video-based oral hygiene instruction |
| model group | Experimental | Phase 1 periodontal therapy + model-based oral hygiene instruction Receives: Behavioral: Model-based oral hygiene instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plaque index
Plaque index (Silness \& Löe) to evaluate the individual oral hygiene performance of the patient. Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
Measured: Baseline (T0) and 1 month (T1)
Change in gingival index
Gingival index (Löe\&Silness) evaluates the inflammatory response of the gingiva due to plaque accumulation. In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
Measured: Baseline (T0) and 1 month (T1)
Change in awareness score
The numerical value recorded as the awareness score was obtained from the patients' answers to 10 questions in the survey. Each question was answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum. As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
Measured: Baseline (T0) and 1 Month (T1)
Secondary outcomes (2)
Change in probing depth
Pocket depth measurement on probing to assess the amount of destruction caused by periodontal disease at the base of the gingival groove. It is a measurement that gives a numerical value in millimeters, and as the measured number increases, it indicates greater tissue destruction caused by periodontal disease and a deeper periodontal pocket.
Measured: Baseline (T0) and 1 Month (T1)
Change in bleeding on probing
Bleeding on probing is used to determine whether periodontal disease is in an active destructive phase at the base of the gingival groove. The bleeding on probing index is used to detect and record bleeding that may occur upon contact of the probe with the base of the periodontal pocket, and is scored as "present" or "absent".
Measured: Baseline (T0) and 1 Month (T1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start1 Jun 2024
- Primary completion31 Jul 2024
- Study completion1 Feb 2025
Why it stopped: The study record is withdrawn due to administrative errors in the questionnaire methodology section. A new, corrected protocol will be registered.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Plaque-Induced GingivitisStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, İlkim Karadağ, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479706
- Sponsor's protocol ID
- 2024-08/17
- Other IDs
- 1919B012324619
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the trial will be shared
Publications
Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.
PubMed 39887898Lees A, Rock WP. A comparison between written, verbal, and videotape oral hygiene instruction for patients with fixed appliances. J Orthod. 2000 Dec;27(4):323-8. doi: 10.1093/ortho/27.4.323.
PubMed 11099571Lee PL, Othman SA, Fauzi NAA, Hussin MZ. Effectiveness of Video-Based Oral Hygiene Education Reinforcement During Fixed Orthodontic Treatment in Adults: A Randomised Clinical Trial. Int J Dent Hyg. 2026 May;24(2):226-236. doi: 10.1111/idh.70008. Epub 2025 Nov 23.
PubMed 41276919Almotairy N, Aleid AA, Almutairi AS. Effect of consequence-based visual education on oral hygiene outcomes: Randomized controlled clinical trial. J Am Dent Assoc. 2026 Jun;157(6):619-628.e2. doi: 10.1016/j.adaj.2025.11.006. Epub 2026 Jan 9.
PubMed 41511431Ghaffari M, Rakhshanderou S, Ramezankhani A, Noroozi M, Armoon B. Oral Health Education and Promotion Programmes: Meta-Analysis of 17-Year Intervention. Int J Dent Hyg. 2018 Feb;16(1):59-67. doi: 10.1111/idh.12304. Epub 2017 Aug 24.
PubMed 28836347
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Video-Based Versus Model-Based Oral Hygiene Instruction on Clinical Parameters and Disease Awareness in Gingivitis Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07479706
- Acronym / sponsor ID
- 2024-08/17
- Conditions
- Plaque-Induced Gingivitis
- Keywords
- Gingivitis, Dental plaque, Oral hygiene instruction, Disease awareness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study record is withdrawn due to administrative errors in the questionnaire methodology section. A new, corrected protocol will be registered.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 18 Mar 2026 (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.
The aim of this study is to comparatively evaluate the effectiveness of two different oral hygiene instruction methods given in addition to Phase 1 periodontal treatment in patients diagnosed with gingivitis, on periodontal clinical parameters and patient awareness scores, and to examine the relationship between the change in awareness score and clinical improvement. The main question it aims to answer is:
Is video-based visual oral hygiene training as memorable and motivating as hands-on training using a model?
A total of 80 patients who were diagnosed with gingivitis were included in the study. The oral health of the patients was assessed by a researcher using periodontal indices, and patients were asked to complete a 10-question questionnaire to assess their own periodontal health and oral hygiene status (T0). Following baseline measurements, all patients received standard Phase 1 periodontal treatment by another clinician. At the end of treatment, patients were randomly assigned to two different oral hygiene instruction (OHI) groups of 40 each:
Group 1 (Video Group): Oral hygiene instruction in this group was provided through standard video content; Group 2 (Model Group): Oral hygiene instruction was given through practical demonstration using three-dimensional dental models.
Patients were called for a follow-up appointment one month after the Phase 1 periodontal treatment (T1). All initial clinical indices were measured and recorded, and patients were asked to complete the same awareness questionnaire again.
Detailed description
The periodontal indices to be evaluated at time points T0 and T1 in the study was determined as follows:
- Plaque index (Löe \& Silness) to evaluate the individual oral hygiene performance of the patient. Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
- Gingival index (Sillness \& Löe) evaluates the inflammatory response of the gingiva due to plaque accumulation. In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
- Pocket depth measurement on probing to assess the amount of destruction caused by periodontal disease at the base of the gingival groove. It is a measurement that gives a numerical value in millimeters, and as the measured number increases, it indicates greater tissue destruction caused by periodontal disease and a deeper periodontal pocket.
- Bleeding on probing is used to determine whether periodontal disease is in an active destructive phase at the base of the gingival groove. The bleeding on probing index is used to detect and record bleeding that may occur upon contact of the probe with the base of the periodontal pocket, and is scored as "present" or "absent".
The numerical value recorded as the awareness score is obtained from the patients' answers to 10 questions in the survey. Each question is answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum. As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
Periodontal measurements and patient awareness questionnaire scores from both time points were recorded, and pairwise comparisons, analysis of covariance, and correlation analyses were conducted to analyze the observed change and evaluate the response of the two groups to treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| video group | Experimental | Behavioral: video-based oral hygiene instructionPhase 1 periodontal therapy + Video-based oral hygiene instruction |
| model group | Experimental | Behavioral: Model-based oral hygiene instructionPhase 1 periodontal therapy + model-based oral hygiene instruction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Having an average whole-mouth gingival index (GI) score above 2.0
Key exclusion criteria (9 listed)
- Individuals with an average gingival index below 2.0,
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 |
|---|---|---|
| video-based oral hygiene instructionFollowing standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received standardized oral hygiene instruction via a video presentation. The video demonstrated proper tooth brushing and interdental cleaning techniques. A link to the video was also provided to the patients for at-home reinforcement. | Behavioural | video group |
| Model-based oral hygiene instructionFollowing standard Phase 1 periodontal therapy (scaling and root planing), patients in this group received practical oral hygiene instruction demonstrated on a 3D dental model by the researcher. The demonstration included proper tooth brushing and interdental cleaning techniques. | Behavioural | model group |
Primary outcome
Change in plaque index
Time frame: Baseline (T0) and 1 month (T1)
Plaque index (Silness \& Löe) to evaluate the individual oral hygiene performance of the patient. Plaque index measurements are given on a scale of 0 (no plaque) to 3 (presence of plaque or tartar buildup), and higher scores indicate less success in individual oral hygiene practices for the patient.
Change in gingival index
Time frame: Baseline (T0) and 1 month (T1)
Gingival index (Löe\&Silness) evaluates the inflammatory response of the gingiva due to plaque accumulation. In this measurement, the inflammation of the gums is evaluated using a numerical value between 0 (no edema, healthy gums) and 3 (red, bleeding, and swollen gums), and the higher the score, the greater the severity of gum disease.
Change in awareness score
Time frame: Baseline (T0) and 1 Month (T1)
The numerical value recorded as the awareness score was obtained from the patients' answers to 10 questions in the survey. Each question was answered with a value between "0" (disagree) and "4" (strongly agree), and the total value obtained from the answers to the 10 questions represents the sum. As the score approaches the minimum value of 0, it indicates that the individual has fewer complaints related to gum disease, while a total score close to the maximum value of 40 indicates that the individual suffers more from the discomfort caused by gum disease.
2 secondary outcomes
Change in probing depth
Time frame: Baseline (T0) and 1 Month (T1)
Change in bleeding on probing
Time frame: Baseline (T0) and 1 Month (T1)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 39887898Demirel A, Guclu HS, Guclu M, Bagis N. Evaluation of Effects of Verbal and Video-Based Instructions on the Improvement of Oral Hygiene Status in Children: A Randomised Clinical Trial. Int J Dent Hyg. 2025 Aug;23(3):575-583. doi: 10.1111/idh.12898. Epub 2025 Jan 29.
- Background: PubMed 11099571Lees A, Rock WP. A comparison between written, verbal, and videotape oral hygiene instruction for patients with fixed appliances. J Orthod. 2000 Dec;27(4):323-8. doi: 10.1093/ortho/27.4.323.
- Background: PubMed 41276919Lee PL, Othman SA, Fauzi NAA, Hussin MZ. Effectiveness of Video-Based Oral Hygiene Education Reinforcement During Fixed Orthodontic Treatment in Adults: A Randomised Clinical Trial. Int J Dent Hyg. 2026 May;24(2):226-236. doi: 10.1111/idh.70008. Epub 2025 Nov 23.
- Background: PubMed 41511431Almotairy N, Aleid AA, Almutairi AS. Effect of consequence-based visual education on oral hygiene outcomes: Randomized controlled clinical trial. J Am Dent Assoc. 2026 Jun;157(6):619-628.e2. doi: 10.1016/j.adaj.2025.11.006. Epub 2026 Jan 9.
- Background: PubMed 28836347Ghaffari M, Rakhshanderou S, Ramezankhani A, Noroozi M, Armoon B. Oral Health Education and Promotion Programmes: Meta-Analysis of 17-Year Intervention. Int J Dent Hyg. 2018 Feb;16(1):59-67. doi: 10.1111/idh.12304. Epub 2017 Aug 24.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the trial will be shared
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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.
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 video-based oral hygiene instruction and Model-based oral hygiene instruction in people with Plaque-Induced Gingivitis, run by Ankara University 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 1 inclusion and 9 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: withdrawn, as of the sponsor's last update on 10 Sep 2026. 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 was withdrawn before enrolling participants, so there are no results.
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?
Change in plaque index (time frame: Baseline (T0) and 1 month (T1)). The study lists 3 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 NCT07479706, which also lists 5 linked publications.
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 10 Sep 2026.