Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy

NCT06247007 | Completed

• 1 other identifier: 2024/ EA
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• Clinical periodontal parameters / bleeding on probing (BOP)

  The presence of bleeding on probing is considered an objective sign of periodontal inflammation

  Baseline-week 3

• 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

• 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

• Biochemical findings

  IL-6, IL-10, TNF-α

  Baseline-day 7-week 3

Study Arms (2)

EA (electroacupuncture)

EXPERIMENTAL

Individuals who underwent electroacupuncture addition to non-surgical periodontal therapy

Procedure: Electroacupuncture

Control

NO INTERVENTION

Individuals who have non-surgical periodontal therapy only

Interventions

Electroacupuncture PROCEDURE

LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.

EA (electroacupuncture)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• absence of any systemic disease,
• pregnancy or breast feeding;
• not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;

You may not qualify if:

• 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)

Sponsors & Collaborators

• Didem OZKAL EMINOGLU: lead
• Ataturk University: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Periodontal Pocket

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• DİDEM ÖZKAL EMİNOĞLU

  Ataturk University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 7, 2024
• Study Start: August 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)