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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06247007
Other study ID # 2024/ EA
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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)

Study Design


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
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