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Completed

NCT Number: NCT07053878

Changes in Bruxism Activity After Periodontal Treatment in Patients With Periodontitis

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.

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Key information

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUS

Siena, 53100, Italy

About this study

This is a non-randomized controlled pre-post clinical study designed to investigate the impact of periodontal treatment on awake and sleep bruxism in individuals with advanced periodontitis. Two groups will be included: a periodontitis group undergoing full non-surgical periodontal therapy (step 1 and 2), and a healthy control group receiving supragingival plaque removal and polishing. All participants will receive standardized oral hygiene instructions and motivation. Bruxism activity will be recorded using portable electromyography (EMG) devices at baseline and after three months, evaluating both sleep and awake bruxism through Bruxism Work Index (BWI) and Bruxism Time Index (BTI). Clinical periodontal parameters will also be collected at both time points to assess potential correlations with bruxism variation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Bruxism Episodes

    Time frame: Baseline and 3 months

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

Sponsors and collaborators

Lead sponsor

University of Siena

Other

Registry information

Official study title

Impact of Non-Surgical Periodontal Therapy on Awake and Sleep Bruxism in Patients With Stage III-IV Periodontitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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