An interventional study of scaling and root planing and Subgingival instrumentation in Periodontitis and Bruxism, sponsored by Postgraduate Institute of Dental Sciences Rohtak. Recruiting at 1 site in India. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Postgraduate Institute of Dental Sciences Rohtak · Not applicable, Interventional, and Treatment
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.
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 :
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.
1,231 studies on the registry are indexed under Periodontitis; 295 are open to participants now.
This study's planned enrollment of 58 is above the median of 44 across 846 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Postgraduate Institute of Dental Sciences Rohtak is the lead sponsor of 213 studies on the registry; 72 are open to participants now.
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TEST GROUP
CONTROL GROUP
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All the participants will undergo scaling and root planing
Procedure: scaling and root planing
All the participants will undergo subgingival instrumentation
Procedure: Subgingival instrumentation
All the participants will undergo scaling and root planing
Also known as: SRP
All the participants will undergo subgingival instrumentation
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.
Time frame: BASELINE,2 MONTHS ,3 MONTHS,6 MONTHS
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.
Time frame: BASELINE,2 MONTHS,3 MONTHS 6 MONTHS
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.
Time frame: BASELINE, 2 MONTHS, 3MONTHS, 6 MONTHS
Plan to share: No
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Started Sep 2023 (actual). Primary completion is estimated for Sep 2024, 12 months after the start.
Of 480 non-industry interventional studies with no phase under Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 31. This study's planned 12 months is below that.
Counting every sponsor, half of 494 studies reached it within 16 months; a quarter within 8 and three quarters within 31.
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