## Protocol Section
### Identification Module
**NCT ID:** NCT06429917

**Brief Title:** Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis

**Official Title:** Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis- An Interventional Study

#### Organization Study ID Info
**ID:** PGIDS/BHRC/24/37
#### Organization
**Class:** OTHER
**Full Name:** Postgraduate Institute of Dental Sciences Rohtak
### Status Module
#### Completion Date
**Date:** 2025-09

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-28

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-08

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-28
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-21
**Study First Submit QC Date:** 2024-05-21
### 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:** This study aims to explore the mechanisms by which periodontal disease affects the bruxers and to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers among patients with periodontitis .

**Detailed Description:** Patients with chronic periodontitis usually describe itching and persistent pain of moderate intensity. Applying masticatory pressure provides relief in these symptoms. However, this practice may lead to the development of bruxism habits in patients over time.

A deeper comprehension of the dynamic interplay between periodontal health and bruxism is crucial for crafting holistic treatment approaches aimed at addressing both symptoms and root causes effectively.

Till now, there has been no report examining the effect of subgingival instrumentation on probable bruxers in periodontitis patients.

. This study aims to assess the impact of subgingival instrumentation on jaw symptoms of probable bruxers in patients with periodontitis

### Conditions Module

**Conditions:**

- Periodontitis

- Bruxism

**Keywords:**

- Inflammation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.

**Intervention Names:**

- Other: Subgingival instrumentation

**Label:** Periodontitis with bruxism

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Periodontitis with bruxism

**Description:** All the participants will undergo subgingival instrumentation with hand scalers, curettes and ultrasonic scaler. Parameters will be recorded at baseline and two, three and six months of time points after subgingival instrumentation.

**Name:** Subgingival instrumentation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.

**Measure:** Jaw symptoms

**Time Frame:** baseline , 2 months , 3 months and 6 months

#### Secondary Outcomes

**Description:** BOP recorded as 1 if bleeding occurs within 15 seconds of probing and 0 (absent) if no bleeding occurred. It will be calculated in %. After adding all the scores, total score will be divided by the total no. of surfaces accessed and multiplied by 100

**Measure:** Bleeding on probing

**Time Frame:** baseline , 2 months , 3 months and 6 months

**Description:** Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation.

**Measure:** Gingival index

**Time Frame:** baseline , 2 months , 3 months and 6 months

**Description:** Probing Pocket Depth (PPD): Probing pocket depth will be measured as the distance from gingival margin to the base of pocket. The probing depth measurements will be assessed using the Periodontal probe. The probe will be inserted in the bottom of pocket and maintained parallel to vertical axis of the tooth. Measurements will be noted at 6sites of a tooth (mesio-buccal, mid-buccal, disto- buccal, mesio-lingual, mid-lingual and disto- lingual). Measurements will be rounded to the nearest whole millimeter.

**Measure:** Probing pocket depth

**Time Frame:** baseline , 2 months , 3 months and 6 months

**Description:** Tooth mobility is assessed using Miller Mobility Index

**Measure:** tooth mobility

**Time Frame:** baseline , 2 months , 3 months and 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 1. Systemically healthy patients 2. Patient having habit of bruxism diagnosed with periodontitis 3. Age between 30-40 years 4. Minimum 20 teeth present in oral cavity

Exclusion Criteria:

1. History of systemic disease such as diabetes or autoimmune disease
2. History of drugs having the potential impact on periodontal status like phenytoin, cyclosporin, calcium-channel blockers or antidepressant drugs.
3. Pregnant or lactating females.
4. Post-menopausal women.
5. Patients diagnosed with temporomandibular disorders- pain and tenderness in the masticatory muscles
6. Patients receiving interventions for bruxism.
7. History of Psychological disorders

**Healthy Volunteers:** True

**Maximum Age:** 40 Years

**Minimum Age:** 30 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** rksharmamds@yahoo.co.in

**Name:** RAJINDER KR SHARMA, MDS

**Phone:** 9416358222

**Role:** CONTACT

**Contact 2:**

**Email:** varsha.kapoor045@gmail.com

**Name:** VARSHA KAPOOR, BDS

**Phone:** 9991802339

**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:** VARSHA KAPOOR, BDS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010510

- Term: Periodontal Diseases

- ID: D000009059

- Term: Mouth Diseases

- ID: D000009057

- Term: Stomatognathic Diseases

- ID: D000014076

- Term: Tooth Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC07

- Name: Mouth and Tooth Diseases

### Condition Browse Module - Browse Leaves

- ID: M10293

- Name: Inflammation

- Relevance: LOW

- As Found: Unknown

- ID: M13427

- Name: Periodontitis

- Relevance: HIGH

- As Found: Periodontitis

- ID: M5286

- Name: Bruxism

- Relevance: HIGH

- As Found: Bruxism

- ID: M13419

- Name: Periodontal Diseases

- Relevance: LOW

- As Found: Unknown

- 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: D000002012

- Term: Bruxism

### Misc Info Module

- Version Holder: 2024-05-31
