Periodontal DiseasesNCT06247007
Electroacupuncture as an Adjunct to Non-Surgical Periodontal Therapy
A study testing Electroacupuncture in people with Periodontal Diseases and Periodontal Inflammation, run by Didem OZKAL EMINOGLU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontal Diseases, Periodontal Inflammation, Periodontitis
- What is being tested?
- Electroacupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Dec 2023
- 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;
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
Official title: Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
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.
Read the 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.
- Conditions
- Periodontal Diseases, Periodontal Inflammation, Periodontitis, Acupuncture, Electroacupuncture, Periodontal Pocket
- Being tested
- Electroacupuncture
- Keywords
- periodontitis, Acupuncture, Electroacupuncture, IL-6, IL-10, TNF-α, Cytokine, non-surgical periodontal therapy
- Medical subject headings
- Periodontal Diseases, Periodontitis, Periodontal Pocket
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureProcedure or surgery
LI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| EA (electroacupuncture) | Experimental | Individuals who underwent electroacupuncture addition to non-surgical periodontal therapy Receives: Procedure: Electroacupuncture |
| Control | No intervention | Individuals who have non-surgical periodontal therapy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline-week 3
Clinical periodontal parameters / bleeding on probing (BOP)
The presence of bleeding on probing is considered an objective sign of periodontal inflammation
Measured: 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
Measured: 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
Measured: Baseline-week 3
Biochemical findings
IL-6, IL-10, TNF-α
Measured: Baseline-day 7-week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Aug 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Didem OZKAL EMINOGLU
- Sponsor type
- University, hospital or other
- Collaborators
- Ataturk University, The Scientific and Technological Research Council of Turkey
- Responsible party
- Sponsor-investigator, Didem OZKAL EMINOGLU, Ataturk University
- Investigators
- DİDEM ÖZKAL EMİNOĞLU, Study director, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247007
- Sponsor's protocol ID
- 2024/ EA
- Status last verified
- Feb 2024
- First submitted
- 29 Jan 2024
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Host Inflammatory Response With Electro Acupuncture as an Adjunct to Non-Surgical Periodontal Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06247007
- Acronym / sponsor ID
- 2024/ EA
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Didem OZKAL EMINOGLUUniversity, hospital or other
- Collaborators
- Ataturk University, The Scientific and Technological Research Council of Turkey
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 7 Feb 2024 (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.
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
- Primary purpose
- Treatment
- 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: ElectroacupunctureIndividuals who underwent electroacupuncture addition to non-surgical periodontal therapy |
| Control | No intervention | –Individuals who have non-surgical periodontal therapy only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- absence of any systemic disease,
- pregnancy or breast feeding;
- not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy;
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 |
|---|---|---|
| ElectroacupunctureLI-4, LI-11, GV-14, GV-20 acupuncture points were needled bilaterally. | Procedure or surgery | EA (electroacupuncture) |
Primary outcome
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
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 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Periodontal Diseases
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
Thermosensitive Hyaluronic Gel With Octenidine as an Adjunctive to Subgingival Instrumentation
Periodontal Disease
Active, not recruitingObservational study
A Retrospective Comparative Evaluation of Omega-3 and Resveratrol Supplementation in Patients With Periodontitis
Periodontitis
Recruiting
Effects of Different Activation Techniques on Antimicrobial Photodynamic Therapy in Apical Periodontitis
Apical Periodontitis, Endodontic Retreatment
Recruiting
Ozone Gel Versus Chlorohexidine Gel as an Adjunct to Non-Surgical Treatment of Stage II Periodontitis Grade B Among Smokers Patients
Ozone Gel, Chlorohexidine Gel
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 in people with Periodontal Diseases and Periodontal Inflammation, 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 3 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 7 Feb 2024. 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?
Clinical periodontal parameters / clinical attachment level (CAL) (time frame: Baseline-week 3). The study lists 6 primary outcomes in all. 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 7 Feb 2024.