Decayed TeethNCT04735120
Laser Activation in Reducing Pain During and After Root Canal Treatment for Painful Lower Molar Teeth.
A study testing iLASE DIODE LASERS in people with Decayed Teeth, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
Trial summary
Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 13 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Decayed Teeth
- What is being tested?
- iLASE DIODE LASERS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2020to 1 Feb 2022
- 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 13 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment
- Patients who respond exaggerated pain with or without lingering response on cold test
Who cannot join
- Patients who do not have pain upon access opening following local anesthesia administration
- Teeth with poor periodontal or restorative prognosis,
- Patients with serious systemic ailments or conditions hindering single visit root canal treatment
- patients not willing to participate in the post operative recall evaluation
- Teeth with anatomic variations and
- Allergic patients are excluded
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Csi College of Dental Sciences and Research
Madurai, 625001
SUBASHRI VISWANATHAN, MDS III YEAR, 9445659453, shrimitha26@gmail.com
About this study
Official title: Effect of Laser Activation on the Intraoperative and Post-treatment Pain in Single Visit Root Canal Treatment for Mandibular Molar Teeth With Acute Irreversible Pulpitis
Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.
Read the detailed description
AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.
MATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.
Single visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).
- Conditions
- Decayed Teeth
- Being tested
- iLASE DIODE LASERS
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iLASE DIODE LASERSDevice
940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed
| Study group | Role | What they receive |
|---|---|---|
| Laser to reduce pain intraoperatively and post operatively | Experimental | Diode lasers are used to assess its efficacy in reducing intraoperative and postoperative pain following root canal treatment in mandibular molar teeth with acute irreversible pulpitis Receives: Device: iLASE DIODE LASERS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application
Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.
Measured: procedure (during root canal treatment)
Secondary outcomes (1)
Change in postoperative pain measured using visual analog scale after root canal treatment
change in post-operative pain following laser application is assessed using 10 point visual analog scale (VAS) over phone call.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start1 Feb 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decayed TeethStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSI College of Dental Sciences and Research, Madurai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr SUBASHRI V, CSI College of Dental Sciences and Research, Madurai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04735120
- Sponsor's protocol ID
- CSICDSR
- Status last verified
- Jan 2021
- First submitted
- 26 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laser Activation on the Intraoperative and Post-treatment Pain in Single Visit Root Canal Treatment for Mandibular Molar Teeth With Acute Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT04735120
- Acronym / sponsor ID
- CSICDSR
- Conditions
- Decayed Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- CSI College of Dental Sciences and Research, MaduraiUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2022 (estimated)
- First posted
- 2 Feb 2021 (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.
Effectiveness of lasers in reducing pain during and after root canal treatment for mandibular molar teeth affected with acute irreversible pulpitis.
Detailed description
AIM : To assess the intraoperative and postoperative pain incidence for single visit root canal treatment for mandibular molar teeth with acute irreversible pulpitis following laser activation.
MATERIALS AND METHODS: The study will account the patients who are referred to the Department of Endodontics,both male and female patients,with pain due to acute irreversible pulpitis from carious mandibular first and second molar teeth requiring root canal treatment. Subjects of age 13 to 70 years who met the inclusion criteria and responded positively to cold test will be included in the study.
Single visit root canal treatment with 2.5 mL of 2% lignocaine containing 1:80,000 adrenaline for an inferior alveolar block injection will be administered for each individual. After achieving anesthesia, patients who exhibit pain following access opening will be subjected to diode laser application on the pulp canal orifices. With regard to intraoperative pain, pre laser and post laser intraoperative pain incidence will be recorded. Once when the intraoperative pain incidence is reduced, patients will be reassessed for the need of additional anesthesia. If fully anesthetised, root canal procedure will be completed. Preoperative, intraoperative( before and laser application) pulse rate will also be measured. The levels of preoperative and post-operative pain at 24 hrs and 48 hrs for each patient will be recorded using a 10-point visual analog scale (VAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser to reduce pain intraoperatively and post operatively | Experimental | Device: iLASE DIODE LASERSDiode lasers are used to assess its efficacy in reducing intraoperative and postoperative pain following root canal treatment in mandibular molar teeth with acute irreversible pulpitis |
Who may qualify
- Ages
- 13 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with painful mandibular molar teeth due to caries with no history of medication intake before 7 days prior to root canal treatment
- Patients who respond exaggerated pain with or without lingering response on cold test
Key exclusion criteria (6 listed)
- Patients who do not have pain upon access opening following local anesthesia administration
- Teeth with poor periodontal or restorative prognosis,
- Patients with serious systemic ailments or conditions hindering single visit root canal treatment
- patients not willing to participate in the post operative recall evaluation
- Teeth with anatomic variations and
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 |
|---|---|---|
| iLASE DIODE LASERS940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed | Device | Laser to reduce pain intraoperatively and post operatively |
Primary outcome
Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application
Time frame: procedure (during root canal treatment)
Change in pain is assessed in 10 point visual analog scale (VAS) before and after laser application.
1 secondary outcome
Change in postoperative pain measured using visual analog scale after root canal treatment
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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This Feasibility Study Will Evaluate the Study Protocols for Treatment and Follow-up Controls of Primary Molars With Caries in Children Treated With Stainless Steel Crowns or Conventional Fillings. Treatment Success and Potential Failures Will be Followed at 3, 6 and 12 Months Post Treatment.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iLASE DIODE LASERS in people with Decayed Teeth, run by CSI College of Dental Sciences and Research, Madurai at 1 site in India.
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 2 inclusion and 6 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 4 Feb 2021. 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 India. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in intraoperative pain measured using visual analog scale during root canal treatment following laser application (time frame: procedure (during root canal treatment)). 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 4 Feb 2021.