NCT05783011

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 24, 2023

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

9 months

First QC Date

March 13, 2023

Last Update Submit

March 24, 2023

Conditions

Keywords

PeriodontitisAcupunctureElectroacupuncture

Outcome Measures

Primary Outcomes (1)

  • 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')

    7 days

Secondary Outcomes (1)

  • Postoperative analgesic requirement

    7 days

Study Arms (2)

EA (electroacupuncture)

EXPERIMENTAL

Individuals who underwent electroacupuncture before and after flap surgery

Procedure: ElectroacupunctureProcedure: periodontal flap surgery

Control

ACTIVE COMPARATOR

Individuals who have undergone flap surgery only

Procedure: periodontal flap surgery

Interventions

Electroacupuncture was applied bilaterally to the LI4, ST5 and ST6 acupuncture points before and after periodontal flap surgery

EA (electroacupuncture)

periodontal flap surgery

ControlEA (electroacupuncture)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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;
  • 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

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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk University

Erzurum, 25240_, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontal DiseasesPeriodontitis

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsAcupuncture TherapyComplementary TherapiesElectric Stimulation TherapyPhysical Therapy ModalitiesRehabilitationTranscutaneous Electric Nerve StimulationAnalgesiaAnesthesia and AnalgesiaAnesthesia

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
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

March 13, 2023

First Posted

March 24, 2023

Study Start

March 30, 2021

Primary Completion

December 30, 2021

Study Completion

December 30, 2022

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations