- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07618533
Motivational Interviewing and Subgingival Instrumentation Outcomes in Periodontitis
Effect of Motivational Interviewing on the Outcomes of Subgingival Instrumentation in Patients With Periodontitis
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Akanksha Mahajan
- Numero di telefono: +916284480549
- Email: akankshamahajan81198@gmail.com
Backup dei contatti dello studio
- Nome: Dr. Rajinder Kumar Sharma, MDS
- Numero di telefono: +919416358222
- Email: rksharmamds@yahoo.in
Luoghi di studio
-
-
Haryana
-
Rohtak, Haryana, India, 124001
- Post graduate institute of dental sciences, Rohtak
-
Contatto:
- Dr. Rajinder Kumar Sharma, MDS
- Numero di telefono: +919416358222
- Email: rksharmamds@yahoo.in
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
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: Motivation Interviewing
Participants will receive a single session of motivational interviewing
|
A single individual motivational interviewing session will be delivered to each patient at baseline and 1 month
|
|
Comparatore attivo: Oral hygiene Instructions
General oral hygiene instructions will be given to all the patients in control group at baseline and at 1 month
|
Oral hygiene instructions will be provided to each patient at baseline and at 1 month.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
The Dental Treatment Motivation Scale (DTMS)
Lasso di tempo: Baseline, 3 month, 6 month
|
The Dental Treatment Motivation Scale (DTMS)19 questionnaire will be used to measure each participant's level of motivation.
|
Baseline, 3 month, 6 month
|
|
Patient related outcome Measure
Lasso di tempo: 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).
|
Baseline, 3 month, 6 month
|
|
Evaluation of Patient's Self Efficacy
Lasso di tempo: Baseline, 3 month, 6 month
|
The Oral Hygiene Related Self Efficacy Scale (OHSE) questionnaire will be used for assessing self-efficacy
|
Baseline, 3 month, 6 month
|
Collaboratori e investigatori
Investigatori
- Direttore dello studio: Dr. Rajinder Kumar Sharma, MDS, Post graduate institute of dental sciences, Rohtak
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
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
- Malattie parodontali
- Malattie della bocca
- Malattie stomatognatiche
- Comportamento
- Comportamento sanitario
- Parodontite
- Aderenza e conformità al trattamento
- Servizi sanitari
- Force di lavoro e servizi per le strutture sanitarie
- Discipline e attività comportamentali
- Consulenza direttiva
- Consulenza
- Servizi di salute mentale
- Intervista motivazionale
Altri numeri di identificazione dello studio
- Akanksha Mahajan Perio 26/57
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .