- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07706049
Video vs. Model-Based Oral Hygiene Instruction in Gingivitis Patients
Comparison of Video-Based Versus Model-Based Oral Hygiene Instruction on Clinical Outcomes and the Predictive Role of Self-Efficacy in Gingivitis Patients: A Single-Blind Randomized Clinical Trial
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Background and Rationale Gingivitis is a reversible inflammatory condition of the gingival tissues caused by the accumulation of dental plaque. The gold standard for its prevention and treatment is professional mechanical plaque removal (Phase 1 periodontal therapy) combined with effective, daily supragingival plaque control by the patient. However, maintaining long-term patient compliance and motivation remains a significant clinical challenge. Traditionally, oral hygiene instruction (OHI) involves verbal guidance and practical demonstration of brushing and interdental cleaning techniques on 3D dental models. With the integration of digital health technologies, video-based educational tools have emerged as a viable alternative. Video instructions offer standardized content and optimize the clinician's chair-time, which is highly valuable in busy clinical settings. While clinical indices objectively measure disease severity, contemporary periodontal care increasingly recognizes the crucial role of psychological and behavioral factors in treatment success. Oral hygiene-related self-efficacy (OHSE)-a patient's belief in their ability to maintain oral care habits even under taxing situations-is a key cognitive determinant of behavior change. Therefore, evaluating clinical outcomes in conjunction with OHSE and Patient-Reported Outcome Measures (PROMs) provides a more comprehensive understanding of periodontal healing dynamics.
Study Objectives The primary objective of this study is to compare the short-term clinical efficacy of video-based versus model-based OHI delivered as an adjunct to Phase 1 periodontal treatment in patients with gingivitis. The secondary objective is to evaluate whether patients' baseline OHSE scores predict the amount of clinical improvement (reductions in Plaque Index and Bleeding on Probing) and to assess changes in self-reported gingival symptoms using a Visual Analogue Scale (VAS).
Methodology and Study Design This study is designed as a prospective, randomized, single-blind, parallel-group clinical trial conducted at Ankara University Faculty of Dentistry. The trial enrolls 80 eligible patients diagnosed with plaque-induced gingivitis, characterized by a whole-mouth average Gingival Index (GI) > 2.0 and no probing depths > 4 mm. Patients with a history of systemic diseases affecting periodontal tissues, current smokers, and those who received antibiotic therapy within the last 3 months are excluded.
Clinical and Behavioral Assessments Prior to any intervention (Baseline - T0), a blinded examiner assesses the periodontal health of the participants using the Plaque Index (PI), Gingival Index (GI), Probing Depth (PD), and Bleeding on Probing (BOP) at six sites per tooth. Following the clinical examination, patients complete a validated Oral Hygiene-Related Self-Efficacy (OHSE) questionnaire, which evaluates their confidence in performing toothbrushing, interdental cleaning, and regular dental visits under various psychological barriers. Additionally, patients rate their subjective gingival symptoms (e.g., bleeding, swelling, bad breath) using a 10-point VAS. Intervention Following baseline assessments, all patients receive standard Phase 1 periodontal treatment, consisting of full-mouth supragingival and subgingival scaling and polishing using ultrasonic instruments and hand curettes. Immediately after the mechanical therapy, patients are randomly allocated to one of two groups (1:1 ratio): Video Group: Patients receive a digital link to a standardized instructional video demonstrating proper toothbrushing and interdental cleaning techniques. Model Group: Patients receive one-on-one practical oral hygiene instruction demonstrated by a clinician on a 3D dental model.
Follow-up and Statistical Analysis Patients are recalled at 3 month (T1) post-intervention. The same blinded examiner repeats all clinical measurements (PI, GI, PD, BOP) and patients re-evaluate their subjective gingival symptoms (VAS). Statistical analyses will be performed to assess within-group and between-group variations. The comparison of clinical improvement amounts (Δ T0 - T1) between the Video and Model groups will be conducted using Independent Samples t-tests and Analysis of Covariance (ANCOVA), adjusting for baseline clinical values and initial OHSE scores. Correlation analyses will be employed to examine the predictive relationship between baseline OHSE subsets (particularly interdental cleaning self-efficacy) and objective reductions in periodontal inflammation.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Ankara, Turchia (Türkiye)
- Ankara University Faculty of Dentistry
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion Criteria:
- Patients officially diagnosed with plaque-induced gingivitis.
- Patients having an average whole-mouth Gingival Index (GI) score strictly above 2.0 at baseline.
- Patients aged between 18 and 65 years.
- Patients who have provided written informed consent to participate in the study.
Exclusion Criteria:
- Individuals with an average whole-mouth Gingival Index (GI) score of 2.0 or below.
- Individuals presenting with periodontal pockets deeper than 4 mm in any single area of the mouth.
- Individuals who possess fixed prosthetic restorations on any tooth.
- Individuals who have received any form of professional periodontal treatment within the last 6 months.
- Individuals who currently smoke or use similar tobacco products.
- Individuals who have used systemic antibiotics for any medical or dental reason within the last 3 months.
- Individuals who are physically or cognitively unable to perform adequate daily oral hygiene practices.
- Individuals who have lost 5 or more natural teeth (excluding third molars/wisdom teeth).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Video-Based Instruction
Following standard Phase 1 periodontal treatment (full-mouth supragingival and subgingival scaling and polishing), patients assigned to this arm receive their oral hygiene instruction via a digital video platform.
|
Patients are provided with a digital link to a standardized, audio-visual instructional video.
The video comprehensively demonstrates proper toothbrushing and interdental cleaning techniques.
Patients are instructed to watch the video and use it as a reference to reinforce their daily oral home care routine.
|
|
Comparatore attivo: Model-based Instruction
Following standard Phase 1 periodontal treatment (full-mouth supragingival and subgingival scaling and polishing), patients assigned to this arm receive conventional oral hygiene instruction demonstrated directly by a clinician.
|
A clinician provides a one-on-one, hands-on practical demonstration of proper toothbrushing and interdental cleaning techniques.
This instruction is delivered interactively using a 3-dimensional physical dental model to guide and educate the patient on their daily oral home care routine.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Plaque Index (PI)
Lasso di tempo: Baseline (T0) and 3-Months Follow-up (T1)
|
The Plaque Index evaluates the level of dental plaque accumulation.
Measurements are taken by a blinded examiner at six sites per tooth (mesio-facial, mid-facial, disto-facial, mesio-oral, mid-oral, and disto-oral).
The whole-mouth average score is calculated for each patient.
A decrease in the score represents an improvement in oral hygiene and plaque control.
|
Baseline (T0) and 3-Months Follow-up (T1)
|
|
Change in Gingival Index (GI)
Lasso di tempo: Baseline (T0) and 3-Months Follow-up (T1)
|
The Gingival Index assesses the severity of gingival inflammation.
Measurements are recorded by a blinded examiner at six sites per tooth.
The whole-mouth average score is calculated.
A decrease in the score indicates a reduction in gingival inflammation and clinical improvement.
|
Baseline (T0) and 3-Months Follow-up (T1)
|
|
Change in Bleeding on Probing (BOP) Percentage
Lasso di tempo: Baseline (T0) and 3-Months Follow-up (T1)
|
Bleeding on Probing assesses the presence or absence of gingival bleeding stimulated by a periodontal probe.
It is evaluated at six sites per tooth.
The outcome is calculated as the percentage of bleeding sites relative to the total number of sites evaluated.
A decrease in the percentage indicates reduced inflammation and clinical healing.
|
Baseline (T0) and 3-Months Follow-up (T1)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Baseline Oral Hygiene-Related Self-Efficacy (OHSE) Score
Lasso di tempo: Baseline (T0)
|
The validated OHSE questionnaire evaluates a patient's internal confidence in performing oral hygiene tasks (toothbrushing, interdental cleaning, and attending dental visits) under taxing situations.
It consists of 19 items rated on a 4-point Likert scale (1 = "completely confident not to", 4 = "completely confident").
The total score ranges from 19 to 76. Higher scores indicate greater psychological resilience and self-efficacy.
This is measured prior to intervention to serve as an independent predictive variable for clinical healing.
|
Baseline (T0)
|
|
Change in Patient-Reported Subjective Gingival Health (VAS)
Lasso di tempo: Baseline (T0) and 3-Months Follow-up (T1)
|
Patients evaluate their subjective perception of their own gingival health and symptoms (such as bleeding, swelling, or bad breath) using a 10-point Visual Analogue Scale (VAS).
The scores range from 1 to 10, where 1 indicates "very poor" and 10 indicates "excellent".
An increase in the score represents an improvement in the patient's subjective perception of their gingival health.
|
Baseline (T0) and 3-Months Follow-up (T1)
|
Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- Woelber JP, Bienas H, Fabry G, Silbernagel W, Giesler M, Tennert C, Stampf S, Ratka-Kruger P, Hellwig E. Oral hygiene-related self-efficacy as a predictor of oral hygiene behaviour: a prospective cohort study. J Clin Periodontol. 2015 Feb;42(2):142-9. doi: 10.1111/jcpe.12348. Epub 2015 Jan 21.
- Syrjala AM, Kneckt MC, Knuuttila ML. Dental self-efficacy as a determinant to oral health behaviour, oral hygiene and HbA1c level among diabetic patients. J Clin Periodontol. 1999 Sep;26(9):616-21. doi: 10.1034/j.1600-051x.1999.260909.x.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2024-08
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .