Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

NCT ID: NCT06024447

Last Updated: 2024-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-10-15

Brief Summary

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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

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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 :

1. Adult patients with age group 30-50 years diagnosed with stage III/IV generalized periodontitis.
2. Presence of minimum 20 teeth (Eichner group A1, A2, A3) excluding third molars.

Exclusion Criteria: Patients with

1. Systemic diseases that may affect periodontal disease progression or outcome of treatment (diabetes, autoimmune diseases)
2. Systemic diseases that may affect masticatory ability of the patient (sarcopenia, TMJ disorders, Xerostomia, Acute Pulpitis)
3. History of periodontal treatment within the 6 months
4. Patients wearing orthodontic appliances
5. Diagnosed psychiatric disorder
6. History of antibiotic use within the previous 3 months
7. History of use of Steroid, immunosuppressive and psychiatric drugs
8. Pregnant and lactating women
9. Smoking or substance abuse
10. 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.

Conditions

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Periodontitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stage III and Stage IV Periodontitis

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

Group Type OTHER

Subgingival Instrumentation

Intervention Type PROCEDURE

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

Interventions

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Subgingival Instrumentation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Postgraduate Institute of Dental Sciences Rohtak

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janvi Janvi, BDS

Role: PRINCIPAL_INVESTIGATOR

PGIDS Rohtak

Locations

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Post Graduate Institute of Dental Sciences

Rohtak, Haryana, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Sanjay Tewari, MDS

Role: CONTACT

91-1262-283876

Facility Contacts

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RAJINDER KR SHARMA, MDS

Role: primary

9416358222

Other Identifiers

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JANVIPERIO2023

Identifier Type: -

Identifier Source: org_study_id

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