Periodontal DiseasesNCT03557814
LED Light As An Adjunct Treatment Modality of Periodontal Diseases
A study testing LED appliance during mechanical debridement, LED appliance after mechanical debridement and Mechanical debridement alone in people with Periodontal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
By promoting the cellular activities, it has been shown that the low-level laser therapy (LLLT) is able to accelerate the wound healing, reduce gingival inflammation, relief the discomfort, and serve as an adjunct to the traditional periodontal treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- LED appliance during mechanical debridement, LED appliance after mechanical debridement and Mechanical debridement alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2017to 31 Aug 2018
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 20 years of age
- No pregnancy, major system or chronic disease
- Severe periodontitis
Who cannot join
- Age is under 20 years old
- Pregnant women
- Have a major system or chronic disease
- no gingival inflammation or periodontal destruction
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Po-Chun Chang, 02-23123456 ext. 67709, changpc@ntu.edu.tw
About this study
By promoting the cellular activities, it has been shown that the low-level laser therapy (LLLT) is able to accelerate the wound healing, reduce gingival inflammation, relief the discomfort, and serve as an adjunct to the traditional periodontal treatment. As an economic and environmental friendly alternative of the laser, the effect of 660 nm light-emitting diodes (LED) light in facilitating the healing of the oral soft and hard tissue wounds in vivo has been also demonstrated in our previous studies. The aim of this study is to further investigate the feasibility of 660 nm LED light appliance in support of the non-surgical periodontal therapy (NSPT).
The LED light appliance will be fabricated by JETTS Technology Co., and the adjunct effect of the LED light on the treatment of periodontitis will be evaluated. Patients with at least one periodontitis-involved teeth in three quadrants will be recruited, and three protocols of LED light irradiation, including LED light irradiation from initial clinical assessment (T0) until the completion of scaling and root planning (T1) (LED01), LED light irradiation from T1 until re-evaluation (T2) (LED02), and no LED light irradiation (control treatment), will be randomly assigned to individual quadrant during the non-surgical periodontal therapy. Clinical parameters will be assessed at T0 and T2, and biomarkers, including IL-1b and MMP-8, from gingival crevicular fluid will be assessed at T0, T1, and T2.
It is expected that 660 nm LED light irradiation,regardless of the timing of irradiation, significantly reduce the discomfort of the periodontal treatment, gingival inflammation, and accelerate healing, and hopefully a prototype of LED light appliance for the periodontal treatment could be developed.
Read the detailed description
Will recruit 40 volunteers with moderate to advanced periodontal destruction, and all participants will receive 2-3 months full mouth NSPT. Two LED light irradiation protocols will be randomly assigned to two quadrants with periodontitis-infected teeth of each participant. LED01 refers to LED light irradiation once per day from the day of initial clinical assessment (T0) until the completion of ScRP (T1, 4-6 weeks after the first visit). LED02 refers to LED light irradiation once per day from T1 until the day of re-evaluation (T2), and the interval of T1 to T2 was the same as that of T0 to T1. The control treatment refers to no LED light irradiation from T0 until T2. The quadrant without LED light irradiation will be served as control. Each participant will be assigned a cross-arch appliance equipped with the semi-conductors of LED bilaterally (Figure 1B), and the external surface will be covered with aluminum foils to prevent the penetration of the LED light.The irradiation will be controlled by an external controller which will be set to emit 660 nm light with an energy density of 10 J/cm2 or 5 J/cm2 unilaterally. The volunteer will be supervised to use the device every day from T0 to T2.
The periodontal examination and the gingival crevicular fluid from the volunteers will be collected at T0, T1, and T2. The volunteers will be also requested to examine the visual analogue scale at these time points.
Will evaluate the change of periodontal parameters, the visual analogue scale, and the inflammatory biomarkers (from gingival crevicular fluid), in order to confirm the adjunct therapeutic effect of the LED light device and figure out the most appropriate protocol for the clinical use.
- Conditions
- Periodontal Diseases
- Being tested
- LED appliance during mechanical debridement, LED appliance after mechanical debridement, Mechanical debridement alone
- Keywords
- chronic periodontitis, light-emitting diodes
- Medical subject headings
- Periodontal Diseases, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED appliance during mechanical debridementDevice
Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
LED appliance after mechanical debridementDevice
Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
Mechanical debridement aloneDevice
Mechanical debridement by periodontal curets alone
| Study group | Role | What they receive |
|---|---|---|
| LED01 | Active comparator | Conventional non-surgical periodontal therapy plus LED light irradiation from T0-T1 Receives: Device: LED appliance during mechanical debridement |
| LED02 | Active comparator | Conventional non-surgical periodontal therapy plus LED light irradiation from T1-T2 Receives: Device: LED appliance after mechanical debridement |
| Control | Sham comparator | Conventional non-surgical periodontal therapy without LED light irradiation Receives: Device: Mechanical debridement alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing depth
Measure at six surfaces of tooth
Measured: 12 weeks
Secondary outcomes (7)
Change in clinical attachment level
Measure at six surfaces of tooth
Measured: 12 weeks
Change in gingival recession
Measure at six surfaces of tooth
Measured: 12 weeks
Change in gingival index
Measure at four surfaces of tooth
Measured: 12 weeks
Change in plaque index
Measure at four surfaces of tooth
Measured: 12 weeks
Change in mental status
Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.
Measured: 12 weeks
Change in IL-1b
examine the level in the gingival crevicular fluid
Measured: 12 weeks
Change in gingival crevicular fluid MMP-8
examine the level in the gingival crevicular fluid
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start1 Sep 2017
- Primary completion31 Aug 2018 (estimated)
- Study completion31 Aug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Single group
- Model description
- Split-mouth design in the same volunteer. Different quadrant receives different treatment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Po-Chun Chang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557814
- Sponsor's protocol ID
- 201508099DIPC
- Status last verified
- Jun 2017
- First submitted
- 9 Jun 2017
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LED Light As An Adjunct Treatment Modality of Periodontal Diseases
- ClinicalTrials.gov ID
- NCT03557814
- Acronym / sponsor ID
- 201508099DIPC
- Conditions
- Periodontal Diseases
- Keywords
- chronic periodontitis, light-emitting diodes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 15 Jun 2018 (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.
By promoting the cellular activities, it has been shown that the low-level laser therapy (LLLT) is able to accelerate the wound healing, reduce gingival inflammation, relief the discomfort, and serve as an adjunct to the traditional periodontal treatment. As an economic and environmental friendly alternative of the laser, the effect of 660 nm light-emitting diodes (LED) light in facilitating the healing of the oral soft and hard tissue wounds in vivo has been also demonstrated in our previous studies. The aim of this study is to further investigate the feasibility of 660 nm LED light appliance in support of the non-surgical periodontal therapy (NSPT).
The LED light appliance will be fabricated by JETTS Technology Co., and the adjunct effect of the LED light on the treatment of periodontitis will be evaluated. Patients with at least one periodontitis-involved teeth in three quadrants will be recruited, and three protocols of LED light irradiation, including LED light irradiation from initial clinical assessment (T0) until the completion of scaling and root planning (T1) (LED01), LED light irradiation from T1 until re-evaluation (T2) (LED02), and no LED light irradiation (control treatment), will be randomly assigned to individual quadrant during the non-surgical periodontal therapy. Clinical parameters will be assessed at T0 and T2, and biomarkers, including IL-1b and MMP-8, from gingival crevicular fluid will be assessed at T0, T1, and T2.
It is expected that 660 nm LED light irradiation,regardless of the timing of irradiation, significantly reduce the discomfort of the periodontal treatment, gingival inflammation, and accelerate healing, and hopefully a prototype of LED light appliance for the periodontal treatment could be developed.
Detailed description
Will recruit 40 volunteers with moderate to advanced periodontal destruction, and all participants will receive 2-3 months full mouth NSPT. Two LED light irradiation protocols will be randomly assigned to two quadrants with periodontitis-infected teeth of each participant. LED01 refers to LED light irradiation once per day from the day of initial clinical assessment (T0) until the completion of ScRP (T1, 4-6 weeks after the first visit). LED02 refers to LED light irradiation once per day from T1 until the day of re-evaluation (T2), and the interval of T1 to T2 was the same as that of T0 to T1. The control treatment refers to no LED light irradiation from T0 until T2. The quadrant without LED light irradiation will be served as control. Each participant will be assigned a cross-arch appliance equipped with the semi-conductors of LED bilaterally (Figure 1B), and the external surface will be covered with aluminum foils to prevent the penetration of the LED light.The irradiation will be controlled by an external controller which will be set to emit 660 nm light with an energy density of 10 J/cm2 or 5 J/cm2 unilaterally. The volunteer will be supervised to use the device every day from T0 to T2.
The periodontal examination and the gingival crevicular fluid from the volunteers will be collected at T0, T1, and T2. The volunteers will be also requested to examine the visual analogue scale at these time points.
Will evaluate the change of periodontal parameters, the visual analogue scale, and the inflammatory biomarkers (from gingival crevicular fluid), in order to confirm the adjunct therapeutic effect of the LED light device and figure out the most appropriate protocol for the clinical use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Split-mouth design in the same volunteer. Different quadrant receives different treatment.
| Arm | Type | Receives |
|---|---|---|
| LED01 | Active comparator | Device: LED appliance during mechanical debridementConventional non-surgical periodontal therapy plus LED light irradiation from T0-T1 |
| LED02 | Active comparator | Device: LED appliance after mechanical debridementConventional non-surgical periodontal therapy plus LED light irradiation from T1-T2 |
| Control | Sham comparator | Device: Mechanical debridement aloneConventional non-surgical periodontal therapy without LED light irradiation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 years of age
- No pregnancy, major system or chronic disease
- Severe periodontitis
Key exclusion criteria (4 listed)
- Age is under 20 years old
- Pregnant women
- Have a major system or chronic disease
- no gingival inflammation or periodontal destruction
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 |
|---|---|---|
| LED appliance during mechanical debridementMechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC | Device | LED01 |
| LED appliance after mechanical debridementMechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC | Device | LED02 |
| Mechanical debridement aloneMechanical debridement by periodontal curets alone | Device | Control |
Primary outcome
Change in probing depth
Time frame: 12 weeks
Measure at six surfaces of tooth
7 secondary outcomes
Change in clinical attachment level
Time frame: 12 weeks
Change in gingival recession
Time frame: 12 weeks
Change in gingival index
Time frame: 12 weeks
Change in plaque index
Time frame: 12 weeks
Change in mental status
Time frame: 12 weeks
Change in IL-1b
Time frame: 12 weeks
Change in gingival crevicular fluid MMP-8
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2018.
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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.
Po-Chun Chang principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LED appliance during mechanical debridement, LED appliance after mechanical debridement and Mechanical debridement alone in people with Periodontal Diseases, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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: status not confirmed, as of the sponsor's last update on 15 Jun 2018. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Po-Chun Chang (02-23123456 ext. 67709, changpc@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing depth (time frame: 12 weeks). 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 Jun 2018.