PeriodontitisNCT07053878
Changes in Bruxism Activity After Periodontal Treatment in Patients With Periodontitis
A study testing Non-Surgical Periodontal Therapy (Step 1 & 2) and Supragingival Plaque Removal and Polishing in people with Periodontitis and Bruxism, run by University of Siena at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Periodontitis, Bruxism, Sleep Bruxism
- What is being tested?
- Non-Surgical Periodontal Therapy (Step 1 & 2) and Supragingival Plaque Removal and Polishing
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 Jun 2025to 30 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Non-Surgical Periodontal Therapy on Awake and Sleep Bruxism in Patients With Stage III-IV 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.
Read the 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
- Periodontitis, Bruxism, Sleep Bruxism, Awake Bruxism
- Being tested
- Non-Surgical Periodontal Therapy (Step 1 & 2), Supragingival Plaque Removal and Polishing
- Medical subject headings
- Periodontitis, Bruxism, Sleep Bruxism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Surgical Periodontal Therapy (Step 1 & 2)Procedure or surgery
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 PolishingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Supragingival Plaque Removal and Polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bruxism Episodes
Number of bruxism events measured using portable electromyographic (EMG) devices, at baseline and after periodontal/prophylactic treatment
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start27 Jun 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-group, non-randomized controlled pre-post study
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Siena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola Discepoli, University of Siena
- Investigators
- Nicola Discepoli, DDS, PhD, Principal investigator, Department of Medical Biotechnologies, University of Siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053878
- Sponsor's protocol ID
- PB002
- Status last verified
- Nov 2025
- First submitted
- 27 Jun 2025
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Non-Surgical Periodontal Therapy on Awake and Sleep Bruxism in Patients With Stage III-IV Periodontitis
- ClinicalTrials.gov ID
- NCT07053878
- Acronym / sponsor ID
- PB002
- Conditions
- Periodontitis, Bruxism, Sleep Bruxism, Awake Bruxism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of SienaUniversity, hospital or other
- Study start
- 27 Jun 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 8 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-group, non-randomized controlled pre-post study
| Arm | Type | Receives |
|---|---|---|
| Periodontitis Group | Experimental | Procedure: Non-Surgical Periodontal Therapy (Step 1 & 2)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. |
| Healthy Control Group | Active comparator | Procedure: Supragingival Plaque Removal and PolishingPeriodontally 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Periodontitis Group |
| Supragingival 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. | Procedure or surgery | Healthy Control Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicola Discepoli, DDS, PhD principal investigator
Department of Medical Biotechnologies, University of Siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Surgical Periodontal Therapy (Step 1 & 2) and Supragingival Plaque Removal and Polishing in people with Periodontitis and Bruxism, run by University of Siena at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Bruxism Episodes (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.