Laser AcupunctureNCT06023524
The Effectiveness of Laser Acupuncture and Standard Medication Therapy on Mandibular Post-Odontectomy Patients
A study testing Laser Acupuncture and Standard Medication in people with Laser Acupuncture and Impacted Third Molar Tooth, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Laser Acupuncture, Impacted Third Molar Tooth
- What is being tested?
- Laser Acupuncture and Standard Medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteIndonesia
- Study dates
- 4 Sep 2023to 31 Oct 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Special dental and oral hospital, Faculty of Dentistry, University of Indonesia
Jakarta Pusat, DKI Jakarta, 10430
About this study
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
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.
Read the 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.
- Conditions
- Laser Acupuncture, Impacted Third Molar Tooth
- Being tested
- Laser Acupuncture and Standard Medication, Sham Laser Acupuncture and Standard Medication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser Acupuncture and Standard MedicationDevice
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 and Standard MedicationDevice
Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated
| Study group | Role | What they receive |
|---|---|---|
| Laser Acupuncture and Standard Medication | Experimental | 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. Receives: Device: Laser Acupuncture and Standard Medication |
| Sham Laser Acupuncture and Standard Medication | Sham comparator | 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 Receives: Device: Sham Laser Acupuncture and Standard Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Interincisal Space
Assess the maximum distance of opening the mouth (interincisal space) using calipers
Measured: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Swelling
Assess the swelling dimensions using a tape measure
Measured: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start4 Sep 2023
- Primary completion31 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laser AcupunctureStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonius Hapindra Kasim, Universitas Indonesia
- Investigators
- KEPK FKUI RSCM, Principal investigator, The Ethics Committee of the Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023524
- Sponsor's protocol ID
- 23-06-0952
- Status last verified
- Nov 2023
- First submitted
- 27 Aug 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06023524
- Acronym / sponsor ID
- 23-06-0952
- Conditions
- Laser Acupuncture, Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 4 Sep 2023 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 5 Sep 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture and Standard Medication | Experimental | Device: Laser Acupuncture and Standard MedicationLaser 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 and Standard Medication | Sham comparator | Device: Sham Laser Acupuncture and Standard MedicationSham Laser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Laser Acupuncture and Standard MedicationLaser 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 | Device | Laser Acupuncture and Standard Medication |
| Sham Laser Acupuncture and Standard MedicationLaser Acupuncture: using RJ laser Nogier E program, with 4672Hz, 785 nm and power 70 mW. The laser is turned on but not activated | Device | Sham Laser Acupuncture and Standard Medication |
Primary outcome
Visual Analog Scale
Time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
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
Time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Assess the maximum distance of opening the mouth (interincisal space) using calipers
Swelling
Time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Assess the swelling dimensions using a tape measure
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 8 Nov 2023.
- Individual participant dataSharing planned: Yes
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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.
KEPK FKUI RSCM principal investigator
The Ethics Committee of the Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture and Standard Medication in people with Laser Acupuncture and Impacted Third Molar Tooth, run by Universitas Indonesia at 1 site in Indonesia.
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 8 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 8 Nov 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 Indonesia. 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. Some participants in this study may receive a placebo. 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 Analog Scale (time frame: Day-1 (baseline), Day-3 and Day-7 post-odontectomy). The study lists 3 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 8 Nov 2023.