Impact of Subgingival Instrumentation on Jaw Symptoms of Probable Bruxers Among Patients With Periodontitis

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

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 .

Study Overview

• Status: Completed
• Conditions: Periodontitis; Bruxism
• Intervention / Treatment: Other: Subgingival instrumentation

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

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Periodontitis with bruxism; 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.	Other: Subgingival instrumentation; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Jaw symptoms	Improvement in frequency and intensity of Jaw Symptoms (pain, unpleasantness, sensitivity, tiredness, tension and stiffness) as perceived by the patient.	baseline , 2 months , 3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding on probing	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	baseline , 2 months , 3 months and 6 months
Gingival index	Gingival index by Loe and Silness (1963) will be used to assess severity of gingival inflammation.	baseline , 2 months , 3 months and 6 months
Probing pocket depth	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.	baseline , 2 months , 3 months and 6 months
tooth mobility	Tooth mobility is assessed using Miller Mobility Index	baseline , 2 months , 3 months and 6 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Investigators: Principal Investigator: VARSHA KAPOOR, BDS, PGIDS, ROHTAK

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): August 25, 2025
• Study Completion (Actual): September 16, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: May 21, 2024
• First Posted (Actual): May 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Tooth Diseases; Pathological Conditions, Signs and Symptoms; Behavior; Habits; Periodontitis; Bruxism; Inflammation
• Other Study ID Numbers: PGIDS/BHRC/24/37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No