Use of TENS in Non-surgical Periodontal Treatment

NCT ID: NCT06870747

Last Updated: 2025-03-11

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

2024-02-20

Study Completion Date

2024-07-23

Brief Summary

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the aim of the study is to verify the use of TENS in non-surgical periodontal therapy in order to relief pain

Detailed Description

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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

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Non-surgical Periodontal Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Experimental group

patients who undergo non-surgical periodontal therapy with TENS switch on

Group Type EXPERIMENTAL

use of Transcutaneous electrical neurostimulation

Intervention Type DEVICE

in this study we would like to use for the first time TENS device during non surgical periodontal therapy

Control group

patients who undergo non-surgical periodontal therapy with TENS switch off

Group Type ACTIVE_COMPARATOR

no TENS during non-surgical periodontal therapy

Intervention Type DEVICE

patients in the control group are going to have non surgical periodontal therapy without TENS

Interventions

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use of Transcutaneous electrical neurostimulation

in this study we would like to use for the first time TENS device during non surgical periodontal therapy

Intervention Type DEVICE

no TENS during non-surgical periodontal therapy

patients in the control group are going to have non surgical periodontal therapy without TENS

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of L'Aquila

OTHER

Sponsor Role lead

Responsible Party

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Sara Di Nicolantonio

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of L'Aquila

L’Aquila, Aquila, Italy

Site Status

Countries

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Italy

Other Identifiers

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UL'Aquila

Identifier Type: -

Identifier Source: org_study_id

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