Changes in Bruxism Activity After Periodontal Treatment in Patients With Periodontitis

NCT07053878 | Completed

• 1 other identifier: PB002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This controlled pre-post study evaluates the effect of non-surgical periodontal therapy on awake and sleep bruxism in patients with Stage III and IV periodontitis. Bruxism activity and periodontal status will be assessed at baseline and three months after treatment.

Conditions

Periodontitis; Bruxism; Sleep Bruxism; Awake Bruxism

Outcome Measures

Primary Outcomes (1)

• Change in Bruxism Episodes

  Number of bruxism events measured using portable electromyographic (EMG) devices, at baseline and after periodontal/prophylactic treatment

  Baseline and 3 months

Study Arms (2)

Periodontitis Group

EXPERIMENTAL

Participants with Stage III or IV periodontitis will receive full non-surgical periodontal therapy (step 1 and step 2), along with standardized oral hygiene instructions and motivation. Bruxism activity and periodontal status will be assessed at baseline and after three months.

Procedure: Non-Surgical Periodontal Therapy (Step 1 & 2)

Healthy Control Group

ACTIVE COMPARATOR

Periodontally healthy participants will receive supragingival plaque removal and polishing, along with standardized oral hygiene instructions and motivation. Bruxism activity and periodontal status will be assessed at baseline and after three months.

Procedure: Supragingival Plaque Removal and Polishing

Interventions

Non-Surgical Periodontal Therapy (Step 1 & 2) PROCEDURE

Comprehensive supra- and sub-gingival instrumentation (scaling, root planing, ultrasonic and manual instruments), following EFP step-1 and step-2 protocols. Includes individualized oral-hygiene instruction and motivation.

Periodontitis Group

Supragingival Plaque Removal and Polishing PROCEDURE

Professional supragingival scaling with ultrasonic tips plus rubber-cup polishing in a single session. Includes the same individualized oral-hygiene instruction and motivation provided to the experimental group.

Healthy Control Group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age between 25 and 50 years
• Good general health (ASA I or II)
• Signed informed consent
• Willingness to attend all study visits and follow instructions
• For periodontitis group: diagnosis of Stage III or IV periodontitis according to the 2017 classification
• For healthy control group: no clinical signs of periodontitis

You may not qualify if:

• Systemic diseases or medications affecting the periodontium (e.g., diabetes, immunosuppressants)
• Antibiotic or anti-inflammatory therapy within the last 3 months
• Periodontal treatment in the last 6 months
• Smoking more than 10 cigarettes/day
• Use of occlusal splints or bruxism-targeted therapy in the past 6 months
• Pregnancy or lactation
• Any condition impairing the ability to cooperate or comply with the study protocol

Sponsors & Collaborators

• University of Siena: lead

Study Sites (1)

AOUS

Siena, 53100, Italy

Location

MeSH Terms

Conditions

Periodontitis; Bruxism; Sleep Bruxism

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Nicola Discepoli, DDS, PhD

  Department of Medical Biotechnologies, University of Siena

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two-group, non-randomized controlled pre-post study

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: June 27, 2025
• Primary Completion: October 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

IT (1)