Postoperative PainNCT03711357
Effect of 980nm Diode Laser on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases
A study testing 980 nm diode laser in people with Postoperative Pain, run by Cairo University.
Trial summary
A randomized clinical trial that evaluates the effect of using 980nm diode laser intracanal irradiation on postoperative pain and root canal disinfection in endodontic retreatment cases with chronic periapical lesions Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- 980 nm diode laser
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to Jun 2020
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Endodontic retreatment cases of single rooted teeth with chronic periapical lesions; with periapical radiolucency of less than 1 cm diameter will be selected.
- Teeth with straight root canals.
- Subjects aged between 18-50 years of age.
- No contributory medical history.
- No previous administration of analgesics and / or antibiotics within the previous 2 weeks.
Who cannot join
- Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
- Teeth with curved roots.
- Swelling or sinus tract.
- Mutilated teeth that interfere with proper isolation and seal between visits.
- Subjects with generalized periodontitis, or if the tooth has probing depth of more than 3 mm.
- Subjects with uncontrolled diabetes or debilitating diseases.
- Pregnant or nursing females.
- Systemic disorders that necessitate antibiotic prophylaxis or prevent the use of Ibuprofen.
About this study
Official title: Evaluation of the Effect of 980nm Diode Laser Intracanal Irradiation on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases With Chronic Periapical Lesions
A randomized clinical trial that evaluates the effect of using 980nm diode laser intracanal irradiation on postoperative pain and root canal disinfection in endodontic retreatment cases with chronic periapical lesions
Read the detailed description
The endodontic retreatment procedures will be carried out for the participants, then 980nm Diode laser will be used to disinfect root canals. The researcher will then take microbiological samples of the root canals, to determine count and type of microorganisms in root canals. The subject will be asked to determine his level of pain at 7 days after endodontic retreatment procedures in a visual analogue scale (VAS), and to determine number of analgesic tablets needed to relieve his pain in the given charts. The subject will then return to the clinic 7 days later to bring back his charts. The researcher then will take another microbiological sample of the root canals, and complete the endodontic retreatment procedures.
- Conditions
- Postoperative Pain
- Being tested
- 980 nm diode laser, placebo
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
980 nm diode laserRadiation
980 nm high power diode laser device.
placeboOther
the diode laser fiber optic tip will be inserted in root canals, but will not be activated.
| Study group | Role | What they receive |
|---|---|---|
| laser | Active comparator | 980 nm diode laser (maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter) will be used for four irradiations, of 5 seconds each, after chemo-mechanical preparation procedures. Receives: Radiation: 980 nm diode laser |
| Placebo | Placebo comparator | After chemo-mechanical preparation procedures, the diode laser fiber optic tip will be inserted inside the root canals but not activated. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain, measured using Visual analogue scale (VAS)
Visual analogue scale (VAS) will be used for to record severity of pain. It is a (0-10) scale. Criteria to determine the severity of postoperative pain will be as follows: (0: no pain), (1-3: mild pain), (4-6: moderate pain), (7-10: severe pain).
Measured: 7 days after root canal re-treatment procedures
Secondary outcomes (2)
Root canal disinfection
Number of microorganisms found in root canals will be determined using "Bacterial culture";"Initial sample", 'Pre-lasing sample, "Post-lasing". and "Recolonization sample", in the "Laser group" and "Placebo group".
Measured: Four samples will be taken; first, second and third samples will be taken at first visit of endodontic retreatment procedures. while, the fourth sample will be taken in the second visit (7 days later).
number of analgesic tablets
the participant will determine the number of analgesic tablets needed to relieve his pain after endodontic retreatment procedures.
Measured: At day 7 after endodontic retreatment procedures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study startOct 2018 (estimated)
- Primary completionMay 2020 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A trial with two parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Nabil El-Ezaby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711357
- Sponsor's protocol ID
- Eman Elezaby
- Status last verified
- Oct 2018
- First submitted
- 13 Oct 2018
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make the participants data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of 980nm Diode Laser Intracanal Irradiation on Postoperative Pain and Root Canal Disinfection in Endodontic Retreatment Cases With Chronic Periapical Lesions
- ClinicalTrials.gov ID
- NCT03711357
- Acronym / sponsor ID
- Eman Elezaby
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- May 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 18 Oct 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.
A randomized clinical trial that evaluates the effect of using 980nm diode laser intracanal irradiation on postoperative pain and root canal disinfection in endodontic retreatment cases with chronic periapical lesions
Detailed description
The endodontic retreatment procedures will be carried out for the participants, then 980nm Diode laser will be used to disinfect root canals. The researcher will then take microbiological samples of the root canals, to determine count and type of microorganisms in root canals. The subject will be asked to determine his level of pain at 7 days after endodontic retreatment procedures in a visual analogue scale (VAS), and to determine number of analgesic tablets needed to relieve his pain in the given charts. The subject will then return to the clinic 7 days later to bring back his charts. The researcher then will take another microbiological sample of the root canals, and complete the endodontic retreatment procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A trial with two parallel groups
| Arm | Type | Receives |
|---|---|---|
| laser | Active comparator | Radiation: 980 nm diode laser980 nm diode laser (maximum output of 3 watts and coupled with a fiber optic tip of 200 µm diameter) will be used for four irradiations, of 5 seconds each, after chemo-mechanical preparation procedures. |
| Placebo | Placebo comparator | Other: placeboAfter chemo-mechanical preparation procedures, the diode laser fiber optic tip will be inserted inside the root canals but not activated. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Endodontic retreatment cases of single rooted teeth with chronic periapical lesions; with periapical radiolucency of less than 1 cm diameter will be selected.
- Teeth with straight root canals.
- Subjects aged between 18-50 years of age.
- No contributory medical history.
- No previous administration of analgesics and / or antibiotics within the previous 2 weeks.
Key exclusion criteria (8 listed)
- Retreatment cases with complications such as separated instruments, perforations, ledges, resorption, transportation, calcifications, immature apices and over fillings.
- Teeth with curved roots.
- Swelling or sinus tract.
- Mutilated teeth that interfere with proper isolation and seal between visits.
- Subjects with generalized periodontitis, or if the tooth has probing depth of more than 3 mm.
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 |
|---|---|---|
| 980 nm diode laser980 nm high power diode laser device. | Radiation | laser |
| placebothe diode laser fiber optic tip will be inserted in root canals, but will not be activated. | Other | Placebo |
Primary outcome
postoperative pain, measured using Visual analogue scale (VAS)
Time frame: 7 days after root canal re-treatment procedures
Visual analogue scale (VAS) will be used for to record severity of pain. It is a (0-10) scale. Criteria to determine the severity of postoperative pain will be as follows: (0: no pain), (1-3: mild pain), (4-6: moderate pain), (7-10: severe pain).
2 secondary outcomes
Root canal disinfection
Time frame: Four samples will be taken; first, second and third samples will be taken at first visit of endodontic retreatment procedures. while, the fourth sample will be taken in the second visit (7 days later).
number of analgesic tablets
Time frame: At day 7 after endodontic retreatment procedures
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
- Individual participant dataSharing planned: No. There is no plan to make the participants data available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing 980 nm diode laser in people with Postoperative Pain, run by Cairo University.
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 5 inclusion and 8 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 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain, measured using Visual analogue scale (VAS) (time frame: 7 days after root canal re-treatment procedures). 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 Oct 2018.