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The Effects of Electroacupuncture on Postoperative Pain

Primary Purpose

Periodontal Diseases, Periodontitis, Acupuncture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Electroacupuncture
periodontal flap surgery
Sponsored by
Didem OZKAL EMINOGLU
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Periodontal Diseases focused on measuring Periodontitis, Acupuncture, Electroacupuncture

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; having 6 mm or more probable pocket depth and clinical attachment loss in at least 4 or more teeth when called for control 6 weeks after Phase I treatment 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)

Sites / Locations

  • Atatürk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

EA (electroacupuncture)

Control

Arm Description

Individuals who underwent electroacupuncture before and after flap surgery

Individuals who have undergone flap surgery only

Outcomes

Primary Outcome Measures

Visual Analogue Scale
The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

Secondary Outcome Measures

Postoperative analgesic requirement
the number of analgesic requirements taken by patients after periodontal surgery.

Full Information

First Posted
March 13, 2023
Last Updated
March 24, 2023
Sponsor
Didem OZKAL EMINOGLU
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1. Study Identification

Unique Protocol Identification Number
NCT05783011
Brief Title
The Effects of Electroacupuncture on Postoperative Pain
Official Title
The Effects of Electroacupuncture on Postoperative Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 30, 2021 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Didem OZKAL EMINOGLU

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study,the investigators aimed to examine the effect of electroacupuncture application on the amount of pain felt by patients after periodontal surgery. The main question it aims to answer is there any efficiacy of electroacupuncture application on postoperative pain reduction. Participants will get periodontal flap surgery treatment with/without electroacupuncture Researchers will compare EA and control groups to see if there is any relationship between acupuncture application and postoperative pain
Detailed Description
Postoperative pain is an acute pain that begins with surgical trauma and decreases over time with tissue healing. The level of pain and discomfort felt varies from person to person. The patient's sex and age, physiological and psychological structure, operation area, duration of surgery, premedication, type of anesthetic used, postoperative complications and several other environmental factors can affect this level. After the operation, especially within 48 hours, the pain increases and gradually decreases. Postoperative pain may cause an increase in anxiety and general fear and concern. The stress level caused by surgical trauma in the patient delays recovery and increases mortality and morbidity. Electroacupuncture (EA) applies electrical stimulation current to needles placed on acupuncture points. It is mainly used to relieve pain and provide operative analgesia. No study has been found in the literature on the pain-reducing functionality of acupuncture applications in periodontal surgical treatments. In this study, the investigators aimed to examine the effect of electroacupuncture application on the amount of pain felt by patients after periodontal surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Periodontitis, Acupuncture, Electroacupuncture
Keywords
Periodontitis, Acupuncture, Electroacupuncture

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EA (electroacupuncture)
Arm Type
Experimental
Arm Description
Individuals who underwent electroacupuncture before and after flap surgery
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Individuals who have undergone flap surgery only
Intervention Type
Procedure
Intervention Name(s)
Electroacupuncture
Intervention Description
Electroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery
Intervention Type
Procedure
Intervention Name(s)
periodontal flap surgery
Intervention Description
periodontal flap surgery
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
The Visual Analogue Scale consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Postoperative analgesic requirement
Description
the number of analgesic requirements taken by patients after periodontal surgery.
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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; having 6 mm or more probable pocket depth and clinical attachment loss in at least 4 or more teeth when called for control 6 weeks after Phase I treatment 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DİDEM ÖZKAL EMİNOĞLU
Organizational Affiliation
Atatürk University
Official's Role
Study Director
Facility Information:
Facility Name
Atatürk University
City
Erzurum
ZIP/Postal Code
25240_
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effects of Electroacupuncture on Postoperative Pain

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