Clinical trial NCT06024447: 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
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis
Lead sponsor: Postgraduate Institute of Dental Sciences Rohtak
Sponsor class: OTHER
First posted: 2023-09-06
Enrollment: 92
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 :

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.

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

Primary outcomes:
measure: Masticatory performance
timeFrame: Baseline, 2 months, 3 months
measure: Hospital Anxiety and Depression Scale 14
timeFrame: Baseline, 2 months, 3 months
measure: Depression Anxiety and Stress Scale 21
timeFrame: Baseline, 2 months, 3 months
Secondary outcomes:
measure: Pocket Probing Depth
timeFrame: Baseline, 2 months, 3 months
measure: Clinical attachment level
timeFrame: Baseline, 2 months, 3 months
Other outcomes:
Locations:
city: Rohtak
country: India
facility: Post Graduate Institute of Dental Sciences
state: Haryana
Study officials:
affiliation: PGIDS Rohtak
name: Janvi Janvi, BDS
role: PRINCIPAL_INVESTIGATOR
References: