Clinical Trials Directory

Trials / Completed

CompletedNCT07053878

Changes in Bruxism Activity After Periodontal Treatment in Patients With Periodontitis

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
University of Siena · Academic / Other
Sex
All
Age
25 Years – 50 Years
Healthy volunteers
Not accepted

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
PROCEDURENon-Surgical Periodontal Therapy (Step 1 & 2)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.
PROCEDURESupragingival Plaque Removal and PolishingProfessional 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.

Timeline

Start date
2025-06-27
Primary completion
2025-10-30
Completion
2025-10-30
First posted
2025-07-08
Last updated
2025-11-28

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT07053878. Inclusion in this directory is not an endorsement.