Changes in Bruxism Activity After Periodontal Treatment in Patients With Periodontitis

NCT ID: NCT07053878

Last Updated: 2025-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2025-10-30

Brief Summary

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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

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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

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Periodontitis Bruxism Sleep Bruxism Awake Bruxism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two-group, non-randomized controlled pre-post study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Periodontitis Group

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.

Group Type EXPERIMENTAL

Non-Surgical Periodontal Therapy (Step 1 & 2)

Intervention Type 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.

Healthy Control Group

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.

Group Type ACTIVE_COMPARATOR

Supragingival Plaque Removal and Polishing

Intervention Type 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.

Interventions

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Non-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.

Intervention Type PROCEDURE

Supragingival Plaque Removal and Polishing

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Siena

OTHER

Sponsor Role lead

Responsible Party

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Nicola Discepoli

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Discepoli, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medical Biotechnologies, University of Siena

Locations

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AOUS

Siena, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PB002

Identifier Type: -

Identifier Source: org_study_id

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