- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07618533
Motivational Interviewing and Subgingival Instrumentation Outcomes in Periodontitis
Effect of Motivational Interviewing on the Outcomes of Subgingival Instrumentation in Patients With Periodontitis
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus. Periodontal disease can cause physical discomfort and contribute to functional limitations, which in turn affect psychological well-being and self-esteem. Periodontitis poses a significant public health challenge due to its high prevalence and potential to cause tooth loss, disability, and impairments in chewing function and aesthetics. Sustaining periodontal health demands patient led interventions, including self-care practices and attention to lifestyle factors. Interventions based on health behaviour change models to target improvements in patient self-efficacy, enhances treatment adherence and increases the frequency of brushing and flossing. Behavioural determinants related to impaired periodontal health includes inadequate plaque control measures, smoking habits, sedentary living, excess alcohol, stress and detrimental eating behaviours. Although subject to modification, these lifestyle factors still generate substantial disease prevalence and economic demands globally.Motivational interviewing (MI) for periodontology is recommended by 1st European workshop on periodontal education, to enhance patient's intrinsic motivation. MI has been found to be effective in treating a broad range of health-related lifestyle problems, such as substance abuse, obesity, diabetes management, tobacco cessation, and poor adherence to medication regimens.
MI was first described in 1983, by Psychologist William R Miller. It was initially developed as a short term approach for problem drinking. Motivational Interviewing is a person centered counselling approach for eliciting behaviour change by helping clients to explore and resolve ambivalence. MI works by activating patients' own motivation for change and adherence to treatment.
The effective implementation of Motivational Interviewing (MI) depends on the practitioner's expertise in essential micro skills (OARS) i.e, Open-ended questions which promotes conversation between the clinician and patient encouraging patient to speak and the clinician listens; Affirmations that recognize the challenges in behaviour change while promoting patient self-efficacy by validation of their strengths; Reflective listening accounts for understanding patient's expressed thoughts and emotions and Summarization that illustrates the clinician's active listening to the patient and offers a brief outline of the discussion, while also aiding in addressing ambivalence. These OARS skills are used within "RULE" framework i.e- Resisting the righting reflex by suppressing the urge to correct or direct the patients as arguing for change evokes counter arguments from patients. Understanding patient's own motivation by exploring patients' perceptions about their current situations and their own reasons for change rather than clinician imposing their own. Listening to patient with empathy over informing to grasp the patient's perspective and help resolve ambivalence about change. Empowering the patient to support their autonomy and self-efficacy enabling them to envision and pursue solutions.
Given the importance of Patient's education and awareness about their periodontal health, this study seeks to investigate the impact of MI on the outcomes of subgingival instrumentation in patients with periodontitis. It also evaluates MI's effects on patient-reported outcomes, motivation, and self-efficacy. By addressing these gaps, the study aims to offer evidence based insights for enhancing periodontal therapy.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Akanksha Mahajan
- Telefonní číslo: +916284480549
- E-mail: akankshamahajan81198@gmail.com
Studijní záloha kontaktů
- Jméno: Dr. Rajinder Kumar Sharma, MDS
- Telefonní číslo: +919416358222
- E-mail: rksharmamds@yahoo.in
Studijní místa
-
-
Haryana
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Rohtak, Haryana, Indie, 124001
- Post Graduate Institute of Dental Sciences, Rohtak
-
Kontakt:
- Dr. Rajinder Kumar Sharma, MDS
- Telefonní číslo: +919416358222
- E-mail: rksharmamds@yahoo.in
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
• Systemically healthy Patients with age group 30-50 years diagnosed with (Stage I-III) periodontitis.
Exclusion Criteria:
- Systemic diseases that may affect periodontal disease progression or outcome of treatment
- Patients on long term antibiotics
- Pregnant and lactating women
- Female patients with history of menopause
- Current orthodontic treatment or planning to undergo orthodontic treatment during study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Motivation Interviewing
Participants will receive a single session of motivational interviewing
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A single individual motivational interviewing session will be delivered to each patient at baseline and 1 month
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Aktivní komparátor: Oral hygiene Instructions
General oral hygiene instructions will be given to all the patients in control group at baseline and at 1 month
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Oral hygiene instructions will be provided to each patient at baseline and at 1 month.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
The Dental Treatment Motivation Scale (DTMS)
Časové okno: Baseline, 3 month, 6 month
|
The Dental Treatment Motivation Scale (DTMS)19 questionnaire will be used to measure each participant's level of motivation. .
The scale has a total of 15 items, which assess intrinsic (seven questions) and extrinsic motivation (eight questions).
Answers provided on a scale are from 1 to 5, where 1 = "strongly disagree" and 5 = "strongly agree."
Patients will complete the questionnaire at the 3, 6 month follow-up appointment after periodontal treatment.
Higher score indicates higher level of patient motivation towards dental treatment.
|
Baseline, 3 month, 6 month
|
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Patient related outcome Measure
Časové okno: Baseline, 3 month, 6 month
|
The Oral Health Impact Profile-14 (OHIP-14) questionnaire will be used to measure each participant's Oral Health related quality of life (OHRQoL).
It evaluates 14 questions under seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap.
Each item is scored on a 5-point Likert scale (1=never to 5=very often) with total scores ranging from 0-56 (higher scores indicate worse Oral health quality of life).
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Baseline, 3 month, 6 month
|
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Evaluation of Patient's Self Efficacy
Časové okno: Baseline, 3 month, 6 month
|
The Oral Hygiene Related Self Efficacy Scale (OHSE) questionnaire will be used for assessing self-efficacy.
It includes 19 items rated on 4 point Likert scale from (1) Completely confident not to (4) Completely confident.
Higher scores indicate stronger belief in one's ability to maintain oral health, correlating with better hygiene practices and treatment outcomes.
|
Baseline, 3 month, 6 month
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Dr. Rajinder Kumar Sharma, MDS, Post Graduate Institute of Dental Sciences, Rohtak
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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