Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

February 5, 2024 updated by: Didem OZKAL EMINOGLU

Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial

The aim of this randomized, single-masked, controlled clinical trial study was to determine if the administration of electro acupuncture improves the outcomes obtained in combination with non-surgical periodontal therapy.

Participants will get non-surgical periodontal therap with/without electro acupuncture.

Researchers will compare EA and control groups to see if there is any relationship between acupuncture application clinical periodontal parameters,serum and saliva cytokine levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Periodontitis is a prevalent complex chronic inflammatory oral disease that can result in the progressive destruction of tooth supporting tissues and eventual loss of teeth. Although pathogenic bacteria are the triggers and provokers of periodontal inflammation, the main determinant of the destruction is the host immunoinflammatory response. The host response is modified by many genetic and environmental factors as well as various systemic diseases.

Electroacupuncture (EA) has effects on both the immune system and inflammatory processes. The effect of acupuncture on the regulation of cytokine production has been mentioned in the literature. .

No study has been found in the literature about the effects of EA on the host modulation in periodontitis patients. In this study, the investigators aimed to examine the effect of electroacupuncture application on the host modulation at periodontitis.

Study Type

Interventional

Enrollment (Actual)

52

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

  • Turkey
      • Erzurum, Turkey, 25240_
        • Ataturk University

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

No

Description

Inclusion Criteria:

  • absence of any systemic disease,
  • pregnancy or breast feeding;
  • not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;

Exclusion Criteria:

  • Having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure
  • pregnant/breastfeeding
  • medication for any reason
  • smoker/tobacco user
  • other periodontal disease other than periodontitis
  • chronic inflammatory disease (COPD, asthma)

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA (electroacupuncture)
Individuals who underwent electroacupuncture addition to non-surgical periodontal therapy
Procedure: Electroacupuncture
LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.
No Intervention: Control
Individuals who have non-surgical periodontal therapy only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical periodontal parameters / clinical attachment level (CAL)
Time Frame: Baseline-week 3
CAL was measured as the distance between the deepest point of the sulcus and the cemento-enamel junction
Baseline-week 3
Clinical periodontal parameters / probing pocket depth (PPD)
Time Frame: Baseline-week 3
PPD was measured as the distance between the deepest point of the sulcus and the gingival margin
Baseline-week 3
Clinical periodontal parameters / bleeding on probing (BOP)
Time Frame: Baseline-week 3
The presence of bleeding on probing is considered an objective sign of periodontal inflammation
Baseline-week 3
Clinical periodontal parameters / plaque index (PI)
Time Frame: Baseline-week 3
The amount of plaque present on the teeth was assessed using a plaque staining agent and graded according to the plaque index system
Baseline-week 3
Clinical periodontal parameters / gingival index (GI)
Time Frame: Baseline-week 3
The presence and extent of gingival inflammation and bleeding were graded according to the gingival index system
Baseline-week 3
Biochemical findings
Time Frame: Baseline-day 7-week 3
IL-6, IL-10, TNF-α
Baseline-day 7-week 3

Collaborators and Investigators

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

Sponsor

Didem OZKAL EMINOGLU

Collaborators

The Scientific and Technological Research Council of Turkey
Scientific Research Projects Coordınatıon Unit of Atatürk University

Investigators

  • Study Director: Didem Özkal Eminoğlu, Ataturk University

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)

August 1, 2023

Primary Completion (Actual)

December 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

January 29, 2024

First Submitted That Met QC Criteria

February 5, 2024

First Posted (Estimated)

February 7, 2024

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/ EA

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

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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