Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

NCT ID: NCT06247007

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2023-12-01

Brief Summary

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.

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.

Conditions

Periodontal Diseases; Periodontal Inflammation; Periodontitis; Acupuncture; Electroacupuncture; Periodontal Pocket

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

EA (electroacupuncture)

Individuals who underwent electroacupuncture addition to non-surgical periodontal therapy

Group Type: EXPERIMENTAL

Electroacupuncture

Intervention Type: PROCEDURE

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

Control

Individuals who have non-surgical periodontal therapy only

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Electroacupuncture

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

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Didem OZKAL EMINOGLU

OTHER

Sponsor Role: lead

Responsible Party

Didem OZKAL EMINOGLU

assistant professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

DİDEM ÖZKAL EMİNOĞLU

Role: STUDY_DIRECTOR

Ataturk University

Locations

Atatürk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2024/ EA

Identifier Type: -

Identifier Source: org_study_id