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
Verified date | February 2024 |
Source | Ataturk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
Turkey | Atatürk University | Erzurum |
Lead Sponsor | Collaborator |
---|---|
Didem OZKAL EMINOGLU | Scientific Research Projects Coordination Unit of Atatürk University, The Scientific and Technological Research Council of Turkey |
Turkey,
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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