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Completed

NCT Number: NCT06247007

Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

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.

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Key information

Conditions

Periodontal Diseases Acupuncture Electroacupuncture Mouth Diseases Periodontal Inflammation Periodontal Pocket Periodontitis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

electroacupuncture

Procedure

LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.

Primary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. Biochemical findings

    Time frame: Baseline-day 7-week 3

    IL-6, IL-10, TNF-α

Sponsors and collaborators

Lead sponsor

Didem OZKAL EMINOGLU

Other

Collaborators

  • Ataturk University
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 7, 2024
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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