Low-level Light TherapyNCT04006717
Comparison Between Low-level Laser Therapy, Intracanal Cryotherapy and Their Combination, on Post-endodontic Pain Level
A study testing Low Level Laser therapy and Intra canal Cryotherapy in people with Low-level Light Therapy and Cryotherapy, run by Misr International University at 1 site in Egypt.
Trial summary
Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Low-level Light Therapy, Cryotherapy
- What is being tested?
- Low Level Laser therapy and Intra canal Cryotherapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jun 2019to 1 Nov 2024
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients having a molar tooth with symptomatic apical periodontitis indicated for root canal treatment.
- Systemically free patients. ASA I
- Teeth with mature apex.
- Teeth without root resorption.
Who cannot join
- Patients with other pulpal diagnoses.
- Medically compromised patients.
- Pregnant females.
- Patients taking analgesics or anti-inflammatory drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-Endodontic Pain Control Using Low- Level Laser Therapy in Comparison to Intra-canal Cryotherapy: a Randomized Placebo-controlled Clinical Trial
Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of painful situations. Aim of the study: This study is conducted to clinically evaluate and compare the effect of both LLLT and ICCT on post-endodontic pain (PEP) over 5 days in molars with symptomatic apical periodontitis (SAP) using visual analog scale (VAS). Materials \& Methods: This parallel arm, randomized clinical trial will involve 95 systemically free patients with SAP in molars. The patients will be randomly allocated to 5 equal groups as follows: control (no intervention), placebo (mock laser therapy), LLLT, ICCT and a combination of both. Postoperative pain levels after 6 hrs, 12 hrs, on 2nd day and 5th day are going to be assessed on the VAS and shall be noted. Data collected will be tabulated and statistically analysed.
Read the detailed description
Selection of patients:
Ninty-five patients shall be selected from the regular pool of patients visiting Misr International University Dental Clinic Complex. After application of inclusion and exclusion criteria, preoperative and percussion pain shall be recorded on a 10-cm VAS by the patients. Percussion will be performed by tapping on the occlusal surfaces of the teeth with the back of a mirror handle. It will be assessed prior to the root canal treatment by the operator who shall be performing the root canal treatment. Diagnosis of the tooth as symptomatic apical periodontitis will be done according to the book Cohen's Pathways of the Pulp. Clinical symptoms are going to be defined as follows:
- Severe preoperative pain (VAS >6)
- Severe percussion pain (VAS > 6) Patients with all inclusion criteria will be offered to participate in the study.
Grouping of samples:
Each selected patient will get a unique serial code that is previously distributed among the 5 groups randomly. Nineteen patients in each as follows; Group 1: Control (no intervention), Group 2: Placebo (mock laser therapy), Group 3: LLLT, Group 4: ICCT and Group 5: Combination of both LLLT and ICCT. New patients will be incorporated in the study in place of lost patients.
Method:
After the patient signs the attached consent form, profound anesthesia and rubber dam application shall be ensured. Standard chemo-mechanical preparation parameters (Master Apical File: size #25 to #40 k-files depending on anatomical features of the roots) shall be followed. Obturation will be performed using lateral compaction technique. In Group 4 and Group 5, cold saline with temperature ranging from 2-4 °C, will be used as a final rinse using a conventional syringe. LLLT using diode laser (EPIC™ BIOLASE) with wavelength 940nm will be applied towards the tissues surrounding the roots of treated molars in Group 3 and 5 after completing obturation and sealing the access cavity. In Group 2, the diode laser tip shall be placed at approximately 10 mm from the tissue around the apices of the treated roots; however, it won't be activated.
Data collection:
All patients will be instructed to complete a survey at home. Pain is going to be evaluated based upon a questionnaire filled by the patient after 6 hrs, 12 hrs, on 2nd day and 5th day after root canal treatment. Any of the patients taking analgesics after the treatment, shall be advised to note this in the questionnaire. The information collected from the questionnaires covers the occurrence and the intensity of PEP. The intensity of pain will be evaluated on a numeric rating scale (VAS) of 0 for "no pain" to 10 for "unbearable pain". Patients will return the filled questionnaire on the 5th day after treatment and they shall be assured via telephone contact.
Blinding:
Outcome assessors and statistician will be blinded. Both the participants and principal investigators can't be blinded owing to the use of two obviously different methods, LLLT and ICCT or no intervention.
- Conditions
- Low-level Light Therapy, Cryotherapy
- Being tested
- Low Level Laser therapy, Intra canal Cryotherapy
- Keywords
- Post-endodontic pain, Low-level laser, Intracanal cryotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Level Laser therapyDevice
Diode laser (EPIC™ BIOLASE) with wavelength 940nm
Intra canal CryotherapyProcedure or surgery
Irrigation with cold saline 2-4 C
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine root canal treatment |
| Low-Level Laser Placebo | Placebo comparator | Patient informed that laser will be applied but device won't be turned on Receives: Device: Low Level Laser therapy |
| Low-Level Laser Therapy | Experimental | Low-Level Laser Therapy following root canal treatment Receives: Device: Low Level Laser therapy |
| Intracanal Cryotherapy | Experimental | Cold saline irrigation before obturation Receives: Procedure: Intra canal Cryotherapy |
| Combination of LLLT and ICCT | Experimental | Both cold saline irrigation before obturation and Low-level laser Therapy after root canal treatment Receives: Device: Low Level Laser therapy; Procedure: Intra canal Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-endodontic pain
Score on Visual Analogue scale, ranging from 1 (No pain) to 10 (Worst pain)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start24 Jun 2019
- Primary completion1 Jun 2024
- Study completion1 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-level Light TherapyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr International University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Adel Ibrahim Khalaf, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006717
- Sponsor's protocol ID
- MisrIU
- Status last verified
- Feb 2023
- First submitted
- 2 Jul 2019
- Last updated
- 18 Dec 2024
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-Endodontic Pain Control Using Low- Level Laser Therapy in Comparison to Intra-canal Cryotherapy: a Randomized Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04006717
- Acronym / sponsor ID
- MisrIU
- Conditions
- Low-level Light Therapy, Cryotherapy
- Keywords
- Post-endodontic pain, Low-level laser, Intracanal cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Misr International UniversityUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 1 Nov 2024 (actual)
- First posted
- 5 Jul 2019 (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.
Statement of the problem: Postoperative pain following endodontic treatment is a common complication that might require analgesics for pain relief. Low-level laser therapy (LLLT) and Intracanal Cryotherapy (ICCT) are both recommended as non-pharmacological and non-invasive treatment modalities for management of painful situations. Aim of the study: This study is conducted to clinically evaluate and compare the effect of both LLLT and ICCT on post-endodontic pain (PEP) over 5 days in molars with symptomatic apical periodontitis (SAP) using visual analog scale (VAS). Materials \& Methods: This parallel arm, randomized clinical trial will involve 95 systemically free patients with SAP in molars. The patients will be randomly allocated to 5 equal groups as follows: control (no intervention), placebo (mock laser therapy), LLLT, ICCT and a combination of both. Postoperative pain levels after 6 hrs, 12 hrs, on 2nd day and 5th day are going to be assessed on the VAS and shall be noted. Data collected will be tabulated and statistically analysed.
Detailed description
Selection of patients:
Ninty-five patients shall be selected from the regular pool of patients visiting Misr International University Dental Clinic Complex. After application of inclusion and exclusion criteria, preoperative and percussion pain shall be recorded on a 10-cm VAS by the patients. Percussion will be performed by tapping on the occlusal surfaces of the teeth with the back of a mirror handle. It will be assessed prior to the root canal treatment by the operator who shall be performing the root canal treatment. Diagnosis of the tooth as symptomatic apical periodontitis will be done according to the book Cohen's Pathways of the Pulp. Clinical symptoms are going to be defined as follows:
- Severe preoperative pain (VAS >6)
- Severe percussion pain (VAS > 6) Patients with all inclusion criteria will be offered to participate in the study.
Grouping of samples:
Each selected patient will get a unique serial code that is previously distributed among the 5 groups randomly. Nineteen patients in each as follows; Group 1: Control (no intervention), Group 2: Placebo (mock laser therapy), Group 3: LLLT, Group 4: ICCT and Group 5: Combination of both LLLT and ICCT. New patients will be incorporated in the study in place of lost patients.
Method:
After the patient signs the attached consent form, profound anesthesia and rubber dam application shall be ensured. Standard chemo-mechanical preparation parameters (Master Apical File: size #25 to #40 k-files depending on anatomical features of the roots) shall be followed. Obturation will be performed using lateral compaction technique. In Group 4 and Group 5, cold saline with temperature ranging from 2-4 °C, will be used as a final rinse using a conventional syringe. LLLT using diode laser (EPIC™ BIOLASE) with wavelength 940nm will be applied towards the tissues surrounding the roots of treated molars in Group 3 and 5 after completing obturation and sealing the access cavity. In Group 2, the diode laser tip shall be placed at approximately 10 mm from the tissue around the apices of the treated roots; however, it won't be activated.
Data collection:
All patients will be instructed to complete a survey at home. Pain is going to be evaluated based upon a questionnaire filled by the patient after 6 hrs, 12 hrs, on 2nd day and 5th day after root canal treatment. Any of the patients taking analgesics after the treatment, shall be advised to note this in the questionnaire. The information collected from the questionnaires covers the occurrence and the intensity of PEP. The intensity of pain will be evaluated on a numeric rating scale (VAS) of 0 for "no pain" to 10 for "unbearable pain". Patients will return the filled questionnaire on the 5th day after treatment and they shall be assured via telephone contact.
Blinding:
Outcome assessors and statistician will be blinded. Both the participants and principal investigators can't be blinded owing to the use of two obviously different methods, LLLT and ICCT or no intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine root canal treatment |
| Low-Level Laser Placebo | Placebo comparator | Device: Low Level Laser therapyPatient informed that laser will be applied but device won't be turned on |
| Low-Level Laser Therapy | Experimental | Device: Low Level Laser therapyLow-Level Laser Therapy following root canal treatment |
| Intracanal Cryotherapy | Experimental | Procedure: Intra canal CryotherapyCold saline irrigation before obturation |
| Combination of LLLT and ICCT | Experimental | Device: Low Level Laser therapy, Procedure: Intra canal CryotherapyBoth cold saline irrigation before obturation and Low-level laser Therapy after root canal treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients having a molar tooth with symptomatic apical periodontitis indicated for root canal treatment.
- Systemically free patients. ASA I
- Teeth with mature apex.
- Teeth without root resorption.
Key exclusion criteria (4 listed)
- Patients with other pulpal diagnoses.
- Medically compromised patients.
- Pregnant females.
- Patients taking analgesics or anti-inflammatory drugs.
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 |
|---|---|---|
| Low Level Laser therapyDiode laser (EPIC™ BIOLASE) with wavelength 940nm | Device | Combination of LLLT and ICCT, Low-Level Laser Placebo, Low-Level Laser Therapy |
| Intra canal CryotherapyIrrigation with cold saline 2-4 C | Procedure or surgery | Combination of LLLT and ICCT, Intracanal Cryotherapy |
Primary outcome
Post-endodontic pain
Time frame: 5 days
Score on Visual Analogue scale, ranging from 1 (No pain) to 10 (Worst pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Level Laser therapy and Intra canal Cryotherapy in people with Low-level Light Therapy and Cryotherapy, run by Misr International University at 1 site in Egypt.
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 4 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: finished, as of the sponsor's last update on 18 Dec 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Post-endodontic pain (time frame: 5 days). 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 Dec 2024.