Molar, ThirdEarly Phase 1LTTMSNCT06640439
LED Therapy for Third Molar Surgery
A Early Phase 1 study testing photobiomodulation and Antibiotic in people with Molar, Third and Photobiomodulation, run by Huashan Hospital at 1 site in China.
Trial summary
LED Therapy for third molar surgery Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Molar, Third, Photobiomodulation, Photobiomodulation Therapy
- What is being tested?
- photobiomodulation and Antibiotic
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 14 Oct 2024to 14 Apr 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Healthy Asians;
- 20-55 years old;
- Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;
Who cannot join
- Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
- Women who are preparing for pregnancy, pregnant or breastfeeding;
- Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
- Bad habits, such as addicted to smoking, drinking, etc.;
- Volunteers who have recently participated in other clinical trials;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Yanjun Jane Dan, Medical Doctor, +86 15901940897, 15901940897@163.com
About this study
Official title: LED Therapy Using 830 Nm in the Mandibular Third Molar Surgery: Double-blind Randomized Clinical Trial.
LED Therapy for third molar surgery
Read the detailed description
LED Therapy using 830 nm in the mandibular third molar surgery
- Being tested
- photobiomodulation, Antibiotic
- Keywords
- photobiomodulation, LED, 830 nm, third molar surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationDevice
830 nm LED was used to irradiate the post-extraction area
AntibioticDrug
ibuprofen 0.3 g bid for 3 days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Sham comparator | The irradiation protocol was the same as that of the experimental group, and the light source used was simulated light. After surgery, patients took ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days. Receives: Drug: Antibiotic |
| Treatment Group | Experimental | LED light was irradiated 4 times (830 nm, 50 mW/cm2, 60 J/cm2, 1200 s) on D1 (before and after surgery), D2, and D3, which was extraoral irradiation. After surgery, ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days were taken. Receives: Device: photobiomodulation; Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analogue Scale，VAS
Measured: Day 7
Swelling
Facial swelling was measured in 2 planes: the distance between the tragus and lip commissure and the distance between the gonion and external canthus of the eye.
Measured: Day 3; Day 7
Trismus
Trismus was evaluated by measuring the maximum mouth opening between the edges of the upper and lower central incisors with a calibrated ruler.
Measured: Day 3; Day 7
Secondary outcomes (1)
Quality of life score
OHIP-14 Scale
Measured: Day 3; Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start14 Oct 2024 (estimated)
- Primary completion14 Feb 2025 (estimated)
- Study completion14 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar, ThirdStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients who underwent mandibular third molar extraction
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanjun Dan, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640439
- Sponsor's protocol ID
- KY2024-1088
- Other IDs
- Self-financed
- Acronym
- LTTMS
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LED Therapy Using 830 Nm in the Mandibular Third Molar Surgery: Double-blind Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT06640439
- Acronym / sponsor ID
- LTTMS / KY2024-1088
- Keywords
- photobiomodulation, LED, 830 nm, third molar surgery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 14 Oct 2024 (estimated)
- Primary completion
- 14 Feb 2025 (estimated)
- Study completion
- 14 Apr 2025 (estimated)
- First posted
- 15 Oct 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.
LED Therapy for third molar surgery
Detailed description
LED Therapy using 830 nm in the mandibular third molar surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients who underwent mandibular third molar extraction
| Arm | Type | Receives |
|---|---|---|
| Control Group | Sham comparator | Drug: AntibioticThe irradiation protocol was the same as that of the experimental group, and the light source used was simulated light. After surgery, patients took ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days. |
| Treatment Group | Experimental | Device: photobiomodulation, Drug: AntibioticLED light was irradiated 4 times (830 nm, 50 mW/cm2, 60 J/cm2, 1200 s) on D1 (before and after surgery), D2, and D3, which was extraoral irradiation. After surgery, ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days were taken. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Asians;
- 20-55 years old;
- Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;
Key exclusion criteria (5 listed)
- Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
- Women who are preparing for pregnancy, pregnant or breastfeeding;
- Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
- Bad habits, such as addicted to smoking, drinking, etc.;
- Volunteers who have recently participated in other clinical trials;
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 |
|---|---|---|
| photobiomodulation830 nm LED was used to irradiate the post-extraction area | Device | Treatment Group |
| Antibioticibuprofen 0.3 g bid for 3 days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 days after surgery | Drug | Control Group, Treatment Group |
Primary outcome
Pain
Time frame: Day 7
Visual Analogue Scale，VAS
Swelling
Time frame: Day 3; Day 7
Facial swelling was measured in 2 planes: the distance between the tragus and lip commissure and the distance between the gonion and external canthus of the eye.
Trismus
Time frame: Day 3; Day 7
Trismus was evaluated by measuring the maximum mouth opening between the edges of the upper and lower central incisors with a calibrated ruler.
1 secondary outcome
Quality of life score
Time frame: Day 3; Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Molar, Third
RecruitingObservational study
Oral Specimen and Data Acquisition Study of Subjects Requiring Third Molar Removal
Stomatognatic, Tooth Diseases
Not yet recruitingPhase 4
Comparison of Amoxicillin, Clindamycin and Azithromycin Single Doses Antibiotic Prophylaxis in Patient Undergoing Lower Third Molar Extraction
Wisdom Tooth Removal, Antibiotic Prophylaxis
Recruiting
Effect of Alpha-Band Binaural Beats on Stress and Recovery in Third Molar Surgery
Dental Anxiety, Postoperative Pain
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Not yet recruiting
Antibacterial Effect and Soft Tissue Healing of Chlorhexidine-Coated Polyglactin 910 Sutures After Impacted Lower Third Molar Surgery
Impacted Third Molar Tooth, Surgical Wound Healing
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing photobiomodulation and Antibiotic in people with Molar, Third and Photobiomodulation, run by Huashan Hospital at 1 site in China.
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 5 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: opening soon, as of the sponsor's last update on 15 Oct 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 China. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanjun Jane Dan, Medical Doctor (+86 15901940897, 15901940897@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: Day 7). 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 15 Oct 2024.