Clinical trial NCT05995431: Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis.
Official title: Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis: A Comparative Interventional Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Bruxism
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-08-16
Enrollment: 58
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bruxism is a multifaceted phenomenon that has been associated with several factors mediated by the central nervous system3. Bruxism is an umbrella term grouping different motor phenomenon. 'Bruxism is a repetitive jaw-muscle activity characterized by clenching or grinding of the teeth and/or by bracing or thrusting of the mandible. Bruxism has two distinct circadian manifestations: it can occur during sleep (indicated as sleep bruxism) or during wakefulness (indicated as awake bruxism5.

Sleep bruxism is considered to be a putative exacerbating factor, rather than a causative factor of periodontal disease and night-guards have been used as a counter measure. Since 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. Awake bruxism is defined as masticatory muscle activity during wakefulness that is characterized by repetitive or sustained tooth contact and by bracing or thrusting of the mandible.Given the potential impact of abnormal forces on the periodontium, understanding the relationship between bruxism and periodontal disease is crucial for the prevention and management of these conditions. This study aims to explore the mechanisms by which bruxism affects the periodontium and to assess the impact of bruxism in the outcome of subgingival instrumentation for the management of Stage 2 and Stage 3 periodontitis.

Detailed description: AIM : To study the impact of bruxism in the outcome of subgingival instrumentation for the management of Stage 2 and Stage 3 periodontitis.

OBJECTIVES:

To assess the association of bruxism with periodontitis. STUDY DESIGN: An interventional study will be conducted in the Department of Periodontics and Oral implantology PGIDS, Rohtak.

STUDY SETTING: Hospital based study- patients diagnosed with Stage 2 and Stage 3 Periodontitis associated with bruxism will be recruited in study from OPD.

TIME FRAME: 12-14 months

Sociodemographic variables:

Sociodemographic data comprises of :

1. Gender
2. Age
3. Educational level,
4. Occupation status (student, employed, unemployed or retired), 5 Marital status (single, married, divorced or widowed),

6. Average family monthly income.

POPULATION:

Systemically healthy patients with generalized periodontitis : stage 2 and stage 3 of age group of 30-50 years will be recruited in the study from OPD of Periodontology. Recruitment of the patients for the study will be based on eligibility criteria after obtaining informed and written consent.

SAMPLE SIZE:

Sample size determination was done by using G power software. Taking alpha= 0.5 and power of 90% , minimum 23 patients in each group are required to detect a clinically relevant change of 1mm in clinical attachment level with standard deviation of 1mm between both the groups. Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25% drop out rate.

METHOD:

Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining the informed consent. Periodontal parameters will be assessed which include clinical attachment level (CAL), periodontal pocket depth (PPD), bleeding on probing (BOP), Gingival index (GI),Tooth mobility.

SAMPLE SIZE:

Sample size determination was done by using G power software. Taking alpha= 0.5 and power of 90% , minimum 23 patients in each group are required to detect a clinically relevant change of 1mm in clinical attachment level with standard deviation of 1mm between both the groups. Hence a total of 58 patients (29 in each group) will be included in the study expecting a 25% drop out rate.

Eligibility criteria: Inclusion Criteria:

TEST GROUP

* Systemically healthy patients
* Patient having stage 2 or stage 3 periodontitis with bruxism Age between 30-50 years
* Minimum 20 teeth present in oral cavity

CONTROL GROUP

* Systemically healthy patients
* Patient having stage 2 or stage 3 periodontitis without bruxism
* Age between 30-50 years
* Minimum 20 teeth present in oral cavity

Exclusion Criteria:

* History of systemic disease such as diabetes or autoimmune disease
* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
* Pregnant or lactating females

Primary outcomes:
measure: Clinical Attachment Level (CAL)
timeFrame: BASELINE,2 MONTHS ,3 MONTHS,6 MONTHS
measure: Bleeding on probing (BOP)
timeFrame: BASELINE,2 MONTHS,3 MONTHS 6 MONTHS
measure: Pocket Probing Depth (PPD)
timeFrame: BASELINE, 2 MONTHS, 3MONTHS, 6 MONTHS
Secondary outcomes:
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: PT BD SHARMA UHSR, HARYANA
name: Priyanka Chandela, BDS
role: PRINCIPAL_INVESTIGATOR
References: