## Protocol Section
### Identification Module
**NCT ID:** NCT06435208

**Brief Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis

**Official Title:** Impact of Subgingival Instrumentation on Psychological Distress and Mental Health Status in Bruxers With Periodontitis

#### Organization Study ID Info
**ID:** PRIYANKAPERIO2024
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-02-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-17
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Postgraduate Institute of Dental Sciences Rohtak

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Bruxism is a non-functional repetitive jaw-muscle activity characterized by grinding or clenching the teeth. Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism.

**Detailed Description:** Bruxism, characterized by the involuntary grinding or clenching of teeth, is a prevalent parafunctional habit affecting individuals of all ages. Although the etiology is not known exactly, it has been suggested that bruxism is a multifactorial disorder. Periodontitis, a prevalent inflammatory condition affecting the periodontium, has been linked to bruxism in several studies. The coexistence of bruxism and periodontitis poses unique challenges in clinical management of periodontitis. Also, as periodontitis became chronic, the occurrence of depression increased. Stress, anxiety, and depression are the psychological factors most commonly associated with the presence of bruxism. Therefore, this study aims to investigate impact of subgingival instrumentation on psychological distress and mental health status in bruxers with periodontitis.

### Conditions Module

**Conditions:**

- Periodontal Diseases

- Bruxism

- Periodontitis

- Distress, Emotional

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 45

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** subgingival instrumentation will be done in all participants

**Intervention Names:**

- Other: Subgingival instrumentation

**Label:** PERIODONTITIS BRUXISM

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- PERIODONTITIS BRUXISM

**Description:** All the participants will undergo scaling and root planning with hand scalers, curettes and ultrasonic scaler.

**Name:** Subgingival instrumentation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Assessment of psychological distress will be done by using Kessler Psychological distress(K10)

**Measure:** Psychological distress

**Time Frame:** BASELINE,2 MONTHS ,3 MONTHS

**Description:** Assessment of mental health status will be done by using mental health inventory 38

**Measure:** Mental Health Status

**Time Frame:** Baseline, 2 months, 3 months

#### Secondary Outcomes

**Description:** periodontal probing depth

**Measure:** periodontal parameter

**Time Frame:** Baseline, 2 month, 3 month

**Description:** bleeding on probing

**Measure:** periodontal inflammation

**Time Frame:** Baseline, 2 month, 3 month

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Systemically healthy patients
* Patient having periodontitis with bruxism
* Age between 30-50 years

Exclusion Criteria:

* History of mental health disorder
* History of systemic disease
* History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs
* Pregnant or lactating females

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rksharmamds@yahoo.in

**Name:** RAJINDER KR SHARMA, MDS

**Phone:** 9416358222

**Role:** CONTACT

**Contact 2:**

**Email:** priyankachandela48@gmail.com

**Name:** Priyanka Chandela, BDS

**Phone:** +917027019277

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rohtak

**Country:** India

**Facility:** Post Graduate Institute of Dental Sciences

**State:** Haryana

**Zip:** 124001

#### Overall Officials

**Official 1:**

**Affiliation:** PGIDS , ROHTAK

**Name:** Priyanka Chandela, BDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000014076

- Term: Tooth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M13419

- Name: Periodontal Diseases

- Relevance: HIGH

- As Found: Periodontal Diseases

- ID: M5286

- Name: Bruxism

- Relevance: HIGH

- As Found: Bruxism

- ID: M12019

- Name: Mouth Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12017

- Name: Stomatognathic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16831

- Name: Tooth Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010518

- Term: Periodontitis

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000002012

- Term: Bruxism

### Misc Info Module

- Version Holder: 2024-05-31
