Dentinal HypersensitivityNCT03553290
Therapeutic Evaluation of Lower-level Laser for Treating Dentinal Hypersensitivity
A study testing A.R.C. FOX Laser-FOX Q-810nm in people with Dentinal Hypersensitivity, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Dentinal Hypersensitivity
- What is being tested?
- A.R.C. FOX Laser-FOX Q-810nm
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.20-80 year-old with their own will and oral cleaning ability 2.Patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.Gingival recession in at least two regions showed sensitivity of teeth (VAS> 5) 4.No systemic infection 5.No painkillers in the past two weeks 6.Not pregnant or lactating
Who cannot join
- 1.Smoking more than half a pack a day in the past month
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Po-Chun Chang, 02-23123456 ext. 67709, changpc@ntu.edu.tw
About this study
Official title: Lower-level Laser for Treating Dentinal Hypersensitivity
The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.
Read the detailed description
We will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. They will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. Changes in pain status and clinical periodontal index within six months of treatment will be recorded.
- Conditions
- Dentinal Hypersensitivity
- Being tested
- A.R.C. FOX Laser-FOX Q-810nm, Control
- Keywords
- Dentistry, Dentinal Hypersensitivity, lower-level laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A.R.C. FOX Laser-FOX Q-810nmDevice
805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth
ControlProcedure or surgery
Mechanical debridement alone
| Study group | Role | What they receive |
|---|---|---|
| control | Sham comparator | Mechanical debridement alone Receives: Procedure: Control |
| lower-level laser Therapy | Active comparator | Mechanical debridement with lower-level laser therapy
Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy Receives: Device: A.R.C. FOX Laser-FOX Q-810nm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: 6 months
Secondary outcomes (4)
Change in probing depth
Measure at six surfaces of tooth
Measured: 6 months
Change in clinical attachment level
Measure at six surfaces of tooth
Measured: 6 months
Change in gingival recession
Measure at six surfaces of tooth
Measured: 6 months
Change in masticatory mucosa
Measure at mid-buccal aspect of tooth
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2018
- Study start10 Aug 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 Dentinal HypersensitivityStudies 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 individual
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 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
- NCT03553290
- Sponsor's protocol ID
- 201701057DIPA
- Status last verified
- Mar 2018
- First submitted
- 15 Aug 2017
- Last updated
- 18 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 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lower-level Laser for Treating Dentinal Hypersensitivity
- ClinicalTrials.gov ID
- NCT03553290
- Acronym / sponsor ID
- 201701057DIPA
- Conditions
- Dentinal Hypersensitivity
- Keywords
- Dentistry, Dentinal Hypersensitivity, lower-level laser therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 10 Aug 2017 (actual)
- Primary completion
- 31 Aug 2018 (estimated)
- Study completion
- 31 Aug 2018 (estimated)
- First posted
- 12 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.
The aim of this study was to evaluate the efficacy of low energy laser for the treatment of dentinal hypersensitivity due to periodontal therapy.
Detailed description
We will recruit 80 adult patients with obvious symptom of hypersensitivity after periodontal therapy. They will receive low-energy laser treatment, and the area without the symptom of hypersensitivity will be served as control. Changes in pain status and clinical periodontal index within six months of treatment will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth design in the same individual
| Arm | Type | Receives |
|---|---|---|
| control | Sham comparator | Procedure: ControlMechanical debridement alone |
| lower-level laser Therapy | Active comparator | Device: A.R.C. FOX Laser-FOX Q-810nmMechanical debridement with lower-level laser therapy Device: A.R.C. FOX Laser-FOX Q-810nm Mechanical debridement with lower-level laser therapy |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.20-80 year-old with their own will and oral cleaning ability 2.Patients who have been diagnosed with periodontitis and have completed periodontal treatment 3.Gingival recession in at least two regions showed sensitivity of teeth (VAS> 5) 4.No systemic infection 5.No painkillers in the past two weeks 6.Not pregnant or lactating
Key exclusion criteria (1 listed)
- 1.Smoking more than half a pack a day in the past month
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 |
|---|---|---|
| A.R.C. FOX Laser-FOX Q-810nm805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth | Device | lower-level laser Therapy |
| ControlMechanical debridement alone | Procedure or surgery | control |
Primary outcome
Change in mental status
Time frame: 6 months
Visual analogue scale analysis with a score range of 0-10 (0: no discomfort; 10: severe discomfort). Lower score represent a better outcome.
4 secondary outcomes
Change in probing depth
Time frame: 6 months
Change in clinical attachment level
Time frame: 6 months
Change in gingival recession
Time frame: 6 months
Change in masticatory mucosa
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 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 A.R.C. FOX Laser-FOX Q-810nm in people with Dentinal Hypersensitivity, 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 1 inclusion and 1 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 18 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 mental status (time frame: 6 months). 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 18 Jun 2018.