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

Primary Purpose

Periodontitis, Bruxism

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
scaling and root planing
Subgingival instrumentation
Sponsored by
Postgraduate Institute of Dental Sciences Rohtak
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Post Graduate Institute of Dental Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM

AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM

Arm Description

All the participants will undergo scaling and root planing

All the participants will undergo subgingival instrumentation

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
September 17, 2023
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
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1. Study Identification

Unique Protocol Identification Number
NCT05995431
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 : Gender Age Educational level, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Bruxism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PERIODONTITIS STAGE 2 AND STAGE 3 WITH BRUXISM
Arm Type
Experimental
Arm Description
All the participants will undergo scaling and root planing
Arm Title
AGE MATCHED PATIENTS WITH STAGE 2 AND STAGE 3 PERIODONTITIS WITHOUT BRUXISM
Arm Type
Active Comparator
Arm Description
All the participants will undergo subgingival instrumentation
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Other Intervention Name(s)
SRP
Intervention Description
All the participants will undergo scaling and root planing
Intervention Type
Procedure
Intervention Name(s)
Subgingival instrumentation
Intervention Description
All the participants will undergo subgingival instrumentation
Primary Outcome Measure Information:
Title
Clinical Attachment Level (CAL)
Description
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
Title
Bleeding on probing (BOP)
Description
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
Title
Pocket Probing Depth (PPD)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RAJINDER KR SHARMA, MDS
Phone
9416358222
Email
rksharmamds@yahoo.in
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyanka Chandela, BDS
Organizational Affiliation
PT BD SHARMA UHSR, HARYANA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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