Use of TENS in Non-surgical Periodontal Treatment

March 5, 2025 updated by: Sara Di Nicolantonio, University of L'Aquila

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Aquila
      • L'Aquila, Aquila, Italy, 67100
        • University of L'Aquila

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aging more than 18 and of both sexes seeking for non-surgical periodontal treatment

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
patients who undergo non-surgical periodontal therapy with TENS switch on
Device: use of Transcutaneous electrical neurostimulation
in this study we would like to use for the first time TENS device during non surgical periodontal therapy
Active Comparator: Control group
patients who undergo non-surgical periodontal therapy with TENS switch off
Device: no TENS during non-surgical periodontal therapy
patients in the control group are going to have non surgical periodontal therapy without TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tooth pain during non surgical periodontal therapy
Time Frame: 30 minutes
we are going to measure pain with VAS scale
30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Actual)

April 7, 2024

Study Completion (Actual)

July 23, 2024

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 5, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UL'Aquila

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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