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Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

Primary Purpose

Periodontitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
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: Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) Periodontal treatment within the 6 months Patients wearing orthodontic appliances Any diagnosed psychiatric disorder Antibiotic use within the previous 3 months Steroid, immunosuppressive and psychiatric drug use Pregnant and lactating women History of menopause Smoking or substance abuse

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Stage III and Stage IV Periodontitis

    Arm Description

    Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.

    Outcomes

    Primary Outcome Measures

    Masticatory performance
    Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
    Hospital Anxiety and Depression Scale 14
    The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
    Depression Anxiety and Stress Scale 21
    DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.

    Secondary Outcome Measures

    Pocket Probing Depth
    The probe UNC 15 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.
    Clinical attachment level
    Clinical Attachment Level will be measured as a distance between from the base of the clinical pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of involved tooth.

    Full Information

    First Posted
    August 10, 2023
    Last Updated
    August 31, 2023
    Sponsor
    Postgraduate Institute of Dental Sciences Rohtak
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06024447
    Brief Title
    Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress
    Official Title
    Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress in Periodontitis: Stage III and IV
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 15, 2023 (Anticipated)
    Primary Completion Date
    September 15, 2024 (Anticipated)
    Study Completion Date
    October 15, 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
    Yes

    5. Study Description

    Brief Summary
    Patients of Stage III and Stage IV Periodontitis will be assessed for masticatory dysfunction and psychological distress. Subgingival Instrumentation will be done for treating periodontitis. Patients will be re-evaluated after 2 and 3 months in order to assess any change in masticatory dysfunction and psychological distress by improved periodontal health.
    Detailed Description
    Literature reveals that there occurs masticatory dysfunction in patients with Stage III and IV Periodontitis. It has been hypothesized that masticatory dysfunction along with halitosis and aesthetics of the patient can have an effect on the psychological distress in a chronic state. Patients of Stage III and Stage IV Periodontitis with the following criteria will be included : Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: Patients with Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) History of periodontal treatment within the 6 months Patients wearing orthodontic appliances Diagnosed psychiatric disorder History of antibiotic use within the previous 3 months History of use of Steroid, immunosuppressive and psychiatric drugs Pregnant and lactating women Smoking or substance abuse History of Menopause Periodontal clinical parameters: Plaque Index, Gingival Index, Bleeding on Probing, Probing Pocket Depth, Clinical Attachment Level, Mobility Psychological Parameters: Hospital Anxiety and Depression Scale -14 and Depression Anxiety and Stress Scale -21 Quality of Masticatory Dysfunction Questionnaire and Objective evaluation of Masticatory Performance by mixing ability of Hubba Bubba chewing gum. The sample of 84 patients consisting of 42 cases and 42 controls. The patients will be re-evaluated at 2 and 3 months follow up for clinical periodontal parameters, masticatory performance and psychological distress.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    92 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Stage III and Stage IV Periodontitis
    Arm Type
    Other
    Arm Description
    Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.
    Intervention Type
    Procedure
    Intervention Name(s)
    Subgingival Instrumentation
    Intervention Description
    Subgingival Instrumentation will be performed in patients with Stage III and IV periodontitis.
    Primary Outcome Measure Information:
    Title
    Masticatory performance
    Description
    Objective Masticatory Performance will be evaluated using colour mixing ability of a chewing gum, through optoelectronic analysis using a software. Subjective masticatory performance will be calculated using The Quality of Masticatory Function questionnaire which consists of 29 questions related to frequency and difficulty of chewing different types of foods in the previous 2 weeks.
    Time Frame
    Baseline, 2 months, 3 months
    Title
    Hospital Anxiety and Depression Scale 14
    Description
    The HADS constitutes 14 items grouped into two subscales: "anxiety subscale" (HADS-A), as well as "depression subscale" (HADS-D). The responses to the items are graded from 0 (absence of manifestations) to 3 (severe manifestations). Scores are summated to yield the total score, and greater scores indicate more severe anxiety, as well as depressive indications. DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
    Time Frame
    Baseline, 2 months, 3 months
    Title
    Depression Anxiety and Stress Scale 21
    Description
    DASS-21 measures emotional distress in three subcategories of depression (e.g., loss of self-esteem/incentives and depressed mood), anxiety (e.g., fear and anticipation of negative events), and stress (e.g., persistent state of over arousal and low frustration tolerance). It is a self-reporting questionnaire with 21 items (seven items for each category) based on a four-point rating scale. Higher score represents more severe emotional distress.
    Time Frame
    Baseline, 2 months, 3 months
    Secondary Outcome Measure Information:
    Title
    Pocket Probing Depth
    Description
    The probe UNC 15 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.
    Time Frame
    Baseline, 2 months, 3 months
    Title
    Clinical attachment level
    Description
    Clinical Attachment Level will be measured as a distance between from the base of the clinical pocket and the cemento-enamel junction (CEJ). Measurements will be made at 6 sites of involved tooth.
    Time Frame
    Baseline, 2 months, 3 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: Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars. Exclusion Criteria: Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases) Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis) Periodontal treatment within the 6 months Patients wearing orthodontic appliances Any diagnosed psychiatric disorder Antibiotic use within the previous 3 months Steroid, immunosuppressive and psychiatric drug use Pregnant and lactating women History of menopause Smoking or substance abuse
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sanjay Tewari, MDS
    Phone
    91-1262-283876
    Email
    principalpgids@yahoo.in
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janvi Janvi, BDS
    Organizational Affiliation
    PGIDS Rohtak
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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