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Impact of Subgingival Instrumentation on Masticatory Performance and Psychological Distress

P

Postgraduate Institute of Dental Sciences Rohtak

Status

Enrolling

Conditions

Periodontitis

Treatments

Procedure: Subgingival Instrumentation

Study type

Interventional

Funder types

Other

Identifiers

NCT06024447
JANVIPERIO2023

Details and patient eligibility

About

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.

Full 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 :

  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.

Enrollment

92 estimated patients

Sex

All

Ages

30 to 50 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

92 participants in 1 patient group

Stage III and Stage IV Periodontitis
Other group
Description:
Subgingival Instrumentation will be performed in patients with Stage III and Stage IV periodontitis.
Treatment:
Procedure: Subgingival Instrumentation

Trial contacts and locations

1

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Central trial contact

Sanjay Tewari, MDS

Data sourced from clinicaltrials.gov

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