Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06247007
• Other study ID #: 2024/ EA
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Acupuncture
• Electroacupuncture
• Inflammation
• Periodontal Diseases
• Periodontal Inflammation
• Periodontal Pocket
• Periodontitis

Intervention

Procedure:
• Electroacupuncture
LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.

Locations

Country	Name	City	State
Turkey	Atatürk University	Erzurum

Sponsors (3)

Lead Sponsor	Collaborator
Didem OZKAL EMINOGLU	Scientific Research Projects Coordination Unit of Atatürk University, The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

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