Periodontal DiseasesNCT05783011
The Effects of Electroacupuncture on Postoperative Pain
A study testing Electroacupuncture and periodontal flap surgery in people with Periodontal Diseases and Periodontitis, run by Didem OZKAL EMINOGLU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases, Periodontitis, Acupuncture
- What is being tested?
- Electroacupuncture and periodontal flap surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- Periodontal Diseases, Periodontitis, Acupuncture, Electroacupuncture
- Being tested
- Electroacupuncture, periodontal flap surgery
- Keywords
- Periodontitis, Acupuncture, Electroacupuncture
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
Electroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery
periodontal flap surgeryProcedure or surgery
periodontal flap surgery
| Study group | Role | What they receive |
|---|---|---|
| EA (electroacupuncture) | Experimental | Individuals who underwent electroacupuncture before and after flap surgery Receives: Procedure: Electroacupuncture; Procedure: periodontal flap surgery |
| Control | Active comparator | Individuals who have undergone flap surgery only Receives: Procedure: periodontal flap surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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')
Measured: 7 days
Secondary outcomes (1)
Postoperative analgesic requirement
the number of analgesic requirements taken by patients after periodontal surgery.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start30 Mar 2021
- Primary completion30 Dec 2021
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem OZKAL EMINOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- DİDEM ÖZKAL EMİNOĞLU, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783011
- Sponsor's protocol ID
- 2022
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electroacupuncture on Postoperative Pain
- ClinicalTrials.gov ID
- NCT05783011
- Acronym / sponsor ID
- 2022
- Conditions
- Periodontal Diseases, Periodontitis, Acupuncture, Electroacupuncture
- Keywords
- Periodontitis, Acupuncture, Electroacupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Didem OZKAL EMINOGLUUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 24 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EA (electroacupuncture) | Experimental | Procedure: Electroacupuncture, Procedure: periodontal flap surgeryIndividuals who underwent electroacupuncture before and after flap surgery |
| Control | Active comparator | Procedure: periodontal flap surgeryIndividuals who have undergone flap surgery only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElectroacupunctureElectroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery | Procedure or surgery | EA (electroacupuncture) |
| periodontal flap surgeryperiodontal flap surgery | Procedure or surgery | Control, EA (electroacupuncture) |
Primary outcome
Visual Analogue Scale
Time frame: 7 days
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')
1 secondary outcome
Postoperative analgesic requirement
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DİDEM ÖZKAL EMİNOĞLU study director
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture and periodontal flap surgery in people with Periodontal Diseases and Periodontitis, run by Didem OZKAL EMINOGLU at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.