search
Back to results

The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients

Primary Purpose

Laser Acupuncture, Impacted Third Molar Tooth

Status
Recruiting
Phase
Not Applicable
Locations
Indonesia
Study Type
Interventional
Intervention
Laser Acupuncture and Standard Medication
Sham Laser Acupuncture and Standard Medication
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laser Acupuncture

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female subject Age 18 - 40 years Classification of Pell and Gregory class I, II and positions A, B, C Willing to participate in this research and sign informed consent Exclusion Criteria: Pregnancy Have a history of using corticosteroid drugs in the last 3 months Have a history of medication with analgesics at least 24 hours before surgery Have an unstable systemic disease (such as uncontrolled hypertension and diabetes etc.) The patient has a medical emergency / hemodynamically unstable (such as having a hypertensive crisis) Wounds or skin diseases at the location of the acupuncture point irradiation Patients with a history of epilepsy High fever (> 38oC).

Sites / Locations

  • Special dental and oral hospital, Faculty of Dentistry, University of IndonesiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Laser Acupuncture and Standard Medication

Sham Laser Acupuncture and Standard Medication

Arm Description

Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points.

Sham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated

Outcomes

Primary Outcome Measures

Visual Analog Scale
Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
Interincisal Space
Assess the maximum distance of opening the mouth (interincisal space) using calipers
Swelling
Assess the swelling dimensions using a tape measure

Secondary Outcome Measures

Full Information

First Posted
August 27, 2023
Last Updated
September 19, 2023
Sponsor
Indonesia University
search

1. Study Identification

Unique Protocol Identification Number
NCT06023524
Brief Title
The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients
Official Title
The Effectiveness Combination of Laser Acupuncture and Standard Medication on Pain Score, Interincisal Distance and Swelling in Mandibular Third Molar Post-Odontectomy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

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

5. Study Description

Brief Summary
Acute toothache is a problem that often occurs in the oral cavity. Toothache can be caused by an impacted tooth, in which the tooth cannot or will not erupt into its normal position. The American Association of Oral and Maxillofacial Surgeons (AAOMFS) states that 9 out of 10 people have at least one impacted tooth, and impacted mandibular third molars have the greatest prevalence. Laser acupuncture is an acupuncture modality that has the benefit of reducing pain after third molar extraction. The goal of this randomized controlled trial is to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The main objective of this study is to analyze the combination of laser acupuncture and medication significantly improving the patient's pain intensity, interincisal distance and post-odontectomy swelling compared to the combination group of sham laser acupuncture and medication.
Detailed Description
This is a clinical trial study to evaluate the group that received a combination of laser acupuncture and standard medication compared to the group that received the combination of sham laser acupuncture and standard medication alone, in management of post-mandibular odontectomy patients. The required sample was 57 mandibular third molars in male/female subjects post-odontectomy and randomized into 2 groups: (1) combination of laser acupuncture with standard medication and (2) combination of sham laser acupuncture with standard medication. The subjects will receive two times treatment, on day-1 (baseline) and day-3 after odontectomy. The outcome will be assessed on day-1 (baseline), day-3 and day-7 post-odontectomy. Patients and outcome assessors will be blinded to the group allocation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laser Acupuncture, Impacted Third Molar Tooth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Laser Acupuncture and Standard Medication
Arm Type
Experimental
Arm Description
Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points.
Arm Title
Sham Laser Acupuncture and Standard Medication
Arm Type
Sham Comparator
Arm Description
Sham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
Intervention Type
Device
Intervention Name(s)
Laser Acupuncture and Standard Medication
Intervention Description
Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. Dose 4 Joule at the acupuncture body points and 1 Joule at the ear points
Intervention Type
Device
Intervention Name(s)
Sham Laser Acupuncture and Standard Medication
Intervention Description
Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
Rating scale for measuring pain, where the minimum value is 0 = no pain, and the maximum value is 100 = severe pain. A higher scale means worse outcomes.
Time Frame
Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Title
Interincisal Space
Description
Assess the maximum distance of opening the mouth (interincisal space) using calipers
Time Frame
Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Title
Swelling
Description
Assess the swelling dimensions using a tape measure
Time Frame
Day-1 (baseline), Day-3 and Day-7 post-odontectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subject Age 18 - 40 years Classification of Pell and Gregory class I, II and positions A, B, C Willing to participate in this research and sign informed consent Exclusion Criteria: Pregnancy Have a history of using corticosteroid drugs in the last 3 months Have a history of medication with analgesics at least 24 hours before surgery Have an unstable systemic disease (such as uncontrolled hypertension and diabetes etc.) The patient has a medical emergency / hemodynamically unstable (such as having a hypertensive crisis) Wounds or skin diseases at the location of the acupuncture point irradiation Patients with a history of epilepsy High fever (> 38oC).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonius H Kasim, Doctor
Phone
+6281296838259
Email
hapindra@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
The Ethics Committee of the Faculty of Medicine University of Indonesia - Cipto Mangunkusumo Hospital
Phone
+6221315 7008
Email
ec_fkui@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
KEPK FKUI RSCM
Organizational Affiliation
The Ethics Committee of the Faculty of Medicine, University of Indonesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Special dental and oral hospital, Faculty of Dentistry, University of Indonesia
City
Jakarta Pusat
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Special dental and oral hospital University of Indonesia
Phone
0213923145
Email
rskgm.fkg@ui.ac.id

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients

We'll reach out to this number within 24 hrs