Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06023524
Other study ID # 23-06-0952
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 4, 2023
Est. completion date October 31, 2023

Study information

Verified date November 2023
Source Indonesia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 54
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Indonesia Special dental and oral hospital, Faculty of Dentistry, University of Indonesia Jakarta Pusat DKI Jakarta

Sponsors (1)

Lead Sponsor Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Primary Interincisal Space Assess the maximum distance of opening the mouth (interincisal space) using calipers Day-1 (baseline), Day-3 and Day-7 post-odontectomy
Primary Swelling Assess the swelling dimensions using a tape measure Day-1 (baseline), Day-3 and Day-7 post-odontectomy
See also
  Status Clinical Trial Phase
Completed NCT02547896 - Effectiveness of Diclofenac and Its Association to Codeine After Lower Third Molar Extraction. Phase 4
Completed NCT05684601 - Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery N/A
Completed NCT05170516 - The Effect of Saline Irrigation at Different Temperatures on Pain, Edema, and Trismus After Impacted Third Molar Surgery N/A
Completed NCT02481700 - Epidemiological Study on the Surgical Removal of Third Molars
Completed NCT05488028 - 3D Evaluation of Facial Swelling Post Impacted Lower Third Molars Surgery: RCT N/A
Completed NCT05679973 - Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery N/A
Recruiting NCT03741894 - Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery Phase 4
Completed NCT06017570 - Risk Factors for Distal Caries of Second Molars Adjacent to Mandibular Impacted Third Molars N/A
Completed NCT03894722 - Effects of Polyvinylpyrrolidone Iodine on Postoperative Trismus and Swelling During Impacted Third Molar Surgery Phase 4
Completed NCT02837614 - Evaluation of Preoperative Submucosal Dexamethasone in Third Molar Surgery Phase 0
Completed NCT02831374 - Effectiveness of Platelet Rich Plasma in Wound Healing Phase 0
Completed NCT02494856 - Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal Phase 4
Completed NCT02450487 - Influence of Genotype of CYP2C9 on Clinical Efficacy and Pharmacokinetics of Piroxicam After Lower Third Molar Surgery Phase 4
Completed NCT05545553 - Piezosurgery and Conventional Rotary Instruments on Third Molar Surgery N/A
Recruiting NCT03619460 - Clinical Efficacy of a New Piezoelectric Technique for Wisdom Teeth Extraction N/A
Not yet recruiting NCT05143359 - Accuracy of Variables for Impacted Mandibular Third Molar Surgery N/A
Completed NCT03784638 - Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery N/A
Completed NCT03752255 - Verbal and Visual Information Techniques on Anxiety in Third Molar Surgery N/A
Active, not recruiting NCT04349579 - Evaluation of the Effects of Irrigation of the Extraction Socket With Rifamycine Phase 4
Completed NCT03747237 - Assessment of the Relationship Between Edema Measurement Methods After Impacted Mandibular Third Molar Surgery. N/A