Non-surgical Periodontal TherapyNCT06870747
Use of TENS in Non-surgical Periodontal Treatment
A study testing use of Transcutaneous electrical neurostimulation and no TENS during non-surgical periodontal therapy in people with Non-surgical Periodontal Therapy, run by University of L'Aquila at 1 site in Italy.
Trial summary
the aim of the study is to verify the use of TENS in non-surgical periodontal therapy in order to relief pain Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-surgical Periodontal Therapy
- What is being tested?
- use of Transcutaneous electrical neurostimulation and no TENS during non-surgical periodontal therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 20 Feb 2024to 23 Jul 2024
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aging more than 18 and of both sexes seeking for non-surgical periodontal treatment
Who cannot join
- Patients following opioids or analgesic therapies during the study
- Pregnant women
- Patients who have had episodes of epilepsy
- Pace-maker patients
- Patients who did not signed the informed consent to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Ultra Low Frequency TENS During Non-surgical Periodontal Treatment Relieves Pain and Discomfor
the aim of the study is to verify the use of TENS in non-surgical periodontal therapy in order to relief pain
Read the detailed description
non-surgical periodontal therapy could be painfull for some patients and the pain that they may experience can let them avoid therapies, with huge risks for their oral health. Transcutaneous electrical neurostimulation (TENS) is a device largely used in temporomandibular disorders in order to reduce pain. The aim of our study is to analyze the effect of Transcutaneous electrical neurostimulation (TENS) at the tragus during non-surgical periodontal therapy fro pain relief
- Conditions
- Non-surgical Periodontal Therapy
- Being tested
- use of Transcutaneous electrical neurostimulation, no TENS during non-surgical periodontal therapy
- Keywords
- ULF-TENS, pain, non-surgical periodontal therapy, scaling
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
use of Transcutaneous electrical neurostimulationDevice
in this study we would like to use for the first time TENS device during non surgical periodontal therapy
no TENS during non-surgical periodontal therapyDevice
patients in the control group are going to have non surgical periodontal therapy without TENS
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | patients who undergo non-surgical periodontal therapy with TENS switch on Receives: Device: use of Transcutaneous electrical neurostimulation |
| Control group | Active comparator | patients who undergo non-surgical periodontal therapy with TENS switch off Receives: Device: no TENS during non-surgical periodontal therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tooth pain during non surgical periodontal therapy
we are going to measure pain with VAS scale
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start20 Feb 2024
- Primary completion7 Apr 2024
- Study completion23 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-surgical Periodontal TherapyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of L'Aquila
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Di Nicolantonio, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06870747
- Sponsor's protocol ID
- UL'Aquila
- Status last verified
- Jan 2024
- First submitted
- 5 Mar 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Ultra Low Frequency TENS During Non-surgical Periodontal Treatment Relieves Pain and Discomfor
- ClinicalTrials.gov ID
- NCT06870747
- Acronym / sponsor ID
- UL'Aquila
- Conditions
- Non-surgical Periodontal Therapy
- Keywords
- ULF-TENS, pain, non-surgical periodontal therapy, scaling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of L'AquilaUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 23 Jul 2024 (actual)
- First posted
- 11 Mar 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.
the aim of the study is to verify the use of TENS in non-surgical periodontal therapy in order to relief pain
Detailed description
non-surgical periodontal therapy could be painfull for some patients and the pain that they may experience can let them avoid therapies, with huge risks for their oral health. Transcutaneous electrical neurostimulation (TENS) is a device largely used in temporomandibular disorders in order to reduce pain. The aim of our study is to analyze the effect of Transcutaneous electrical neurostimulation (TENS) at the tragus during non-surgical periodontal therapy fro pain relief
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: use of Transcutaneous electrical neurostimulationpatients who undergo non-surgical periodontal therapy with TENS switch on |
| Control group | Active comparator | Device: no TENS during non-surgical periodontal therapypatients who undergo non-surgical periodontal therapy with TENS switch off |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aging more than 18 and of both sexes seeking for non-surgical periodontal treatment
Key exclusion criteria (5 listed)
- Patients following opioids or analgesic therapies during the study
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 |
|---|---|---|
| use of Transcutaneous electrical neurostimulationin this study we would like to use for the first time TENS device during non surgical periodontal therapy | Device | Experimental group |
| no TENS during non-surgical periodontal therapypatients in the control group are going to have non surgical periodontal therapy without TENS | Device | Control group |
Primary outcome
Tooth pain during non surgical periodontal therapy
Time frame: 30 minutes
we are going to measure pain with VAS scale
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 11 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing use of Transcutaneous electrical neurostimulation and no TENS during non-surgical periodontal therapy in people with Non-surgical Periodontal Therapy, run by University of L'Aquila 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 1 inclusion and 5 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 11 Mar 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?
Tooth pain during non surgical periodontal therapy (time frame: 30 minutes). 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 11 Mar 2025.