Clinical trial NCT06247007: Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy
Official title: Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Periodontal Inflammation
Periodontitis
Acupuncture
Electroacupuncture
Periodontal Pocket
Keywords: periodontitis
Acupuncture
Electroacupuncture
IL-6
IL-10
TNF-α
Cytokine
non-surgical periodontal therapy
Lead sponsor: Ataturk University
Sponsor class: OTHER
Collaborators: name: Scientific Research Projects Coordınatıon Unit of Atatürk University
name: The Scientific and Technological Research Council of Turkey
First posted: 2024-02-07
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Clinical periodontal parameters / clinical attachment level (CAL)
timeFrame: Baseline-week 3
measure: Clinical periodontal parameters / probing pocket depth (PPD)
timeFrame: Baseline-week 3
measure: Clinical periodontal parameters / bleeding on probing (BOP)
timeFrame: Baseline-week 3
measure: Clinical periodontal parameters / plaque index (PI)
timeFrame: Baseline-week 3
measure: Clinical periodontal parameters / gingival index (GI)
timeFrame: Baseline-week 3
measure: Biochemical findings
timeFrame: Baseline-day 7-week 3
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
affiliation: Ataturk University
name: DİDEM ÖZKAL EMİNOĞLU
role: STUDY_DIRECTOR
References: