- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07615153
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers
Impact of Distress Level, Sleep Quality and Occlusal Trauma on Periodontal Status Among Bruxers - a Cross Sectional Study
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
The periodontium in sleep bruxism patients suffers from excessive occlusal force for long periods of time during sleep, the function of the periodontium in such patients may differ from that in patients without sleep bruxism.
Bruxism is associated with tooth wear, chipping, cracking, and fracture, tooth mobility, gingival recession, pain, and sensitivity. Tooth mobility can be a serious consequence of bruxism. Tooth mobility has been described as one of the common clinical signs of occlusal trauma. Progressive mobility may be suggestive of ongoing occlusal trauma, but assessments at different time points are necessary to make this determination.
Bruxism has multifactorial etiologies involving central nervous system regulation, psychosocial factors such as stress, and peripheral influences such as occlusal interferences. Psychological stress and poor sleep quality are commonly reported in individuals with sleep bruxism. Sleep disturbances have been linked to elevated muscle activity and increased parafunctional events, potentially contributing to adverse oral health outcomes. Additionally, poor sleep quality has been associated with diminished overall health and may exacerbate inflammatory responses, which are central to periodontal disease progression. These may contribute to adverse oral health outcomes by preventing the "rest and repair" cycle necessary for tissue health. Stress levels and poor sleep quality negatively affect systemic health. These effects are mediated through direct mechanisms such as systemic inflammation, oxidative stress, and immune system impairment, as well as indirect mechanisms involving associated compensatory behaviors. Given that inflammation and oxidative stress are key components in the pathogenesis of periodontitis. Previous epidemiological studies have identified high perceived stress and poor sleep quality as modifiable risk indicators for periodontitis. When stress levels remain chronically elevated and recovery is insufficient due to poor sleep quality, chronic allostatic load responses and dysregulated immune and inflammatory processes are further activated. Therefore, it can be hypothesized that the combined presence of high stress and poor sleep quality may have a more pronounced detrimental effect on the periodontium than either factor alone.
However, inconsistent and conflicting findings have been reported between relationship of stress, sleep quality, and bruxism as a result, highlighting the need for integrated evaluation of these factors within dental research.
In the context of bruxism, occlusal trauma is significant because the repetitive nature of occlusal loading may potentiate periodontal tissue destruction beyond the effects of microbial plaque alone.
Given the multifactorial nature of bruxism and periodontal disease, understanding how psychological (stress), psychological and behavioral (sleep quality), and mechanical (occlusal trauma) factors influence periodontal health in bruxers could enhance diagnostic precision and therapeutic strategies. This study aims to evaluate these relationships to clarify their impact on periodontal status.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Shubham Singh Kaur, BDS
- Puhelinnumero: +91 8168143428
- Sähköposti: kaurqismat1511@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Rajinder Kumar Sharma, MDS
- Puhelinnumero: +91 9416358222
- Sähköposti: rksharmamds@yahoo.in
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
Inclusion Criteria:
Test Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
Control Group:
- Adults aged 30-45 years
- Patients diagnosed with periodontitis according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.
- Patients who are not probable bruxers according to BRUXSCREEN-Q
- Minimum of 20 natural teeth
Exclusion Criteria:
- Systemic conditions affecting periodontium (e.g., diabetes, auto immune disorders)
- History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
- Patients with pulpal pathology
- Pregnant or lactating females
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
probable bruxers according to bruxscreen-q with periodontitis
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification.
Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
|
these scale were assessed using questionnaires in both the groups
Muut nimet:
|
|
patient who are non bruxers according to bruxscreen-q
Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI), Tooth mobility will be assessed using a modified Lindhe and Nyman(1975) degree classification.
Stress level will be assessed by HADS 14, DASS 21, Sleep quality will be assessed with PSQI
|
these scale were assessed using questionnaires in both the groups
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Pittsburgh Sleep Quality Index (PSQI)
Aikaikkuna: baseline
|
The Pittsburgh Sleep Quality Index (PSQI) will be used to assess sleep quality in both groups.
The PSQI is a self-reported questionnaire that measures sleep quality and disturbances over a 1-month time interval.
It yields a global score ranging from a minimum of 0 to a maximum of 21, where higher scores indicate worse sleep quality (a score greater than 5 indicates severe difficulties in at least two areas, or moderate difficulties in more than three areas).
|
baseline
|
|
Depression Anxiety Stress Scales - 21
Aikaikkuna: baseline
|
The Depression Anxiety Stress Scales - 21 (DASS-21) will be used to assess psychological distress levels among both groups.
It is a 21-item self-report questionnaire designed to measure the negative emotional states across three distinct subscale: depression, anxiety, and stress.
Each subscale range from a minimum of 0 to a maximum of 42, where a lesser number indicates normal emotional state and a higher number signifies a increased severity of psychological distress.
Clinically, lower scores falling within the ranges of 0-9 for Depression, 0-7 for Anxiety, and 0-14 for Stress designate a "Normal" status.For Depression, scores progress through Mild (10-13), Moderate (14-20), Severe (21-27), and Extremely Severe (28+) bands.
For Anxiety, elevated scores represent Mild (8-9), Moderate (10-14), Severe (15-19), and Extremely Severe (20+) levels.
|
baseline
|
|
Hospital Anxiety and Depression Scale - 14
Aikaikkuna: baseline
|
The Hospital Anxiety and Depression Scale (HADS) will be used to assess psychological distress levels among both groups.
The HADS is a 14-item self-report rating scale containing two distinct 7-item subscales: one for anxiety (HADS-A) and one for depression (HADS-D).
For each subscale, final scores range from a minimum of 0 to a maximum of 21, where a lesser number indicates a better outcome (absence of distress) and a higher number signifies a worse outcome (increased severity of anxiety or depressive symptoms).
Clinically, scores on either subscale are categorized into specific bands to interpret severity: a lower score between 0-7 represents a "Normal" or non-case state, whereas higher scores indicate elevated distress progression across Mild/Borderline abnormal (8-10), Moderate/Abnormal (11-14), and Severe/Severe abnormal (15-21) brackets.
|
baseline
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Opintojohtaja: Rajinder Kumar Sharma, MDS, Post Graduate Institute Of Dental Sciences, Rohtak
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- Shubham Singh perio 26/56
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .
Kliiniset tutkimukset Pittsburgh Sleep Quality Index (PSQI)
-
Universidade da CoruñaCenter on Information and Communication TechnologiesValmisElämänlaatu | Kognitiivinen rajoite | Nukkua | Ikääntyminen | IkäongelmaEspanja
-
Hungarian Institute of CardiologySemmelweis UniversityTuntematonElämänlaatu | Aorttaläppästenoosi | SydänläppäsairausUnkari