NCT06870747

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 20, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 11, 2025

Completed
Last Updated

March 11, 2025

Status Verified

January 1, 2024

Enrollment Period

2 months

First QC Date

March 5, 2025

Last Update Submit

March 5, 2025

Conditions

Non-surgical Periodontal Therapy

Keywords

ULF-TENSpainnon-surgical periodontal therapyscaling

Outcome Measures

Primary Outcomes (1)

  • Tooth pain during non surgical periodontal therapy

    we are going to measure pain with VAS scale

    30 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: use of Transcutaneous electrical neurostimulation

Control group

ACTIVE COMPARATOR

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

Device: no TENS during non-surgical periodontal therapy

Interventions

use of Transcutaneous electrical neurostimulationDEVICE

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

Experimental group
no TENS during non-surgical periodontal therapyDEVICE

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

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of L'Aquila

L’Aquila, Aquila, 67100, Italy

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 11, 2025

Study Start

February 20, 2024

Primary Completion

April 7, 2024

Study Completion

July 23, 2024

Last Updated

March 11, 2025

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)