Impact of Bruxism in the Outcome of Subgingival Instrumentation for the Management of Stage 2 and Stage 3 Periodontitis.

Periodontitis Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05995431
• Other study ID #: PRIYANKAPERIO2023
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: May 2024
• Source: Postgraduate Institute of Dental Sciences Rohtak
• Contact: RAJINDER KR SHARMA, MDS
• Phone: 9416358222
• Email: rksharmamds[@]yahoo.in
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: November 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Bruxism
• Periodontitis

Intervention

Procedure:
• scaling and root planing
All the participants will undergo scaling and root planing
• Subgingival instrumentation
All the participants will undergo subgingival instrumentation

Locations

Country	Name	City	State
India	Post Graduate Institute of Dental Sciences	Rohtak	Haryana

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Dental Sciences Rohtak

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level (CAL)	CLINICAL ATTACHMENT LEVEL(CAL) Clinical Attachment Level will be measured as a distance betweenfrom the base of the clinicalpocket and the cemencemento-enamel junction (CEJ).Measurements will be made atsites 6 of involved tooth- mesio-buccal, mid-buccal, dismdistobuccal, mesio-lingual, mid-lingual, disto-lingual using UNC-15 probe. Measurements will be rounded to the nearest whole millimetre.	BASELINE,2 MONTHS ,3 MONTHS,6 MONTHS
Primary	Bleeding on probing (BOP)	BLEEDING ON PROBING (BOP) BOP will recorded as 1 (present) if it occurred within 15 sec of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100. It will be designed as; % sites with bleeding on probing.	BASELINE,2 MONTHS,3 MONTHS 6 MONTHS
Primary	Pocket Probing Depth (PPD)	PROBING POCKET DEPTH (PD):Probing pocket depth will be measured as the distance from the gingival margin to the base of the clinical pocket. The probing depth measurements will be assessed using a calibrated manual periodontal probe (PCP- UNC 15 Hu-Friedy, Chicago, IL, USA). The probe will be inserted with a firm, gentle pressure to the bottom of the pocket and maintained parallel to the vertical axis of the tooth. Measurements will be noted at 6 sites of involved tooth - mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual. Measurements will be rounded to the nearest whole millimetre.	BASELINE, 2 MONTHS, 3MONTHS, 6 MONTHS