Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Clinical periodontal parameters / clinical attachment level (CAL)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
EA (electroacupuncture)
Individuals who underwent electroacupuncture addition to non-surgical periodontal therapy
Intervention: Electroacupuncture (Procedure)
Control
Individuals who have non-surgical periodontal therapy only
Outcomes
Primary Outcomes
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
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
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
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
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
Biochemical findings
Time Frame: Baseline-day 7-week 3
IL-6, IL-10, TNF-α
Secondary Outcomes
No secondary outcomes reported
Investigators
Didem OZKAL EMINOGLU
assistant professor
Ataturk University