Pulp NecrosesPhase 2NCT06129643
"Postoperative Pain Following Laser-Assisted Root Canal Treatment: A Randomized Clinical Trial"
A Phase 2 study testing Conventional group, Dual laser group and Combined group in people with Pulp Necroses and Apical Periodontitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necroses, Apical Periodontitis, Pulp Disease, Dental
- What is being tested?
- Conventional group, Dual laser group and Combined group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 1 Feb 2023
- Phase
- Phase 2
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
- Patients complaining of no pain and without fistulous tract
- Closed apex.
- Acceptance to participate in the study.
Who cannot join
- Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
- Periodontal diseases, presence of swelling or fistulous tract.
- Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Postoperative Pain Following Laser-Assisted Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial"
The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. All data will be collected, tabulated, summarized, and statistically analyzed.
Read the detailed description
Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors.
Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. After disinfection, local anesthetic, tooth isolation, access cavity preparation and final obturation. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure All data will be collected, tabulated, summarized, and statistically analyzed.
- Conditions
- Pulp Necroses, Apical Periodontitis, Pulp Disease, Dental
- Being tested
- Conventional group, Dual laser group, Combined group
- Keywords
- laser in endodontics, post-operative pain
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Dental Pulp Diseases, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional groupDrug
Also called (NaOCl/EDTA)
conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA
Dual laser groupDevice
Also called (Er,Cr:YSGG/Diode)
Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection
Combined groupCombination product
Also called (EDTA/Diode)
17% EDTA was used to remove smear layer followed by diode laser for disinfection
| Study group | Role | What they receive |
|---|---|---|
| Conventional group A | Active comparator | Not described Receives: Drug: Conventional group |
| Dual laser group (Er,Cr:YSGG/Diode) | Experimental | Not described Receives: Device: Dual laser group |
| Combined group (EDTA/Diode): | Experimental | Not described Receives: Combination Product: Combined group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS
Postoperative pain assessment
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain".
- Pain level assigned to one of 4 categorical scores:
- No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Measured: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Jan 2022
- Primary completion30 Oct 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Principal investigator, Sara Zakaria Fahim, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06129643
- Sponsor's protocol ID
- FDASU-Rec ID 041909
- Status last verified
- Jun 2026
- First submitted
- 8 Nov 2023
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Postoperative Pain Following Laser-Assisted Root Canal Treatment of Necrotic Teeth With Apical Periodontitis: A Randomized Clinical Trial"
- ClinicalTrials.gov ID
- NCT06129643
- Acronym / sponsor ID
- FDASU-Rec ID 041909
- Conditions
- Pulp Necroses, Apical Periodontitis, Pulp Disease, Dental
- Keywords
- laser in endodontics, post-operative pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 13 Nov 2023 (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 is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient is given pain scale chart Numeric Rating Scale (NRS) to record his/her pain level before any endodontic treatment. All data will be collected, tabulated, summarized, and statistically analyzed.
Detailed description
Postoperative pain is a common complication following conventional endodontic treatment. According to a systematic review, the frequency of endodontic postoperative pain is between 3% and 58% of patients.Postoperative pain is attributed to chemical, mechanical and microbiological factors.
Residual microorganisms remaining due to the complexity of the root canal system and the limited penetration capability of conventional irrigants are directly responsible for Post operative pain The aim of this study is to evaluate in vivo the post operative pain after laser root canal treatment in necrotic teeth in an evidence-based clinical trial. The null hypothesis being tested is that there is no difference in post operative pain between conventional irrigation and the two types of lasers used.
Forty-five patients are equally divided into 3 separate groups :
- Group A (Conventional): 2.5% NaOCL and 17% EDTA.
- Group B(Dual): saline along with Er,Cr:YSGG laser and diode laser combination
- Group C(Combined): saline along with 17% EDTA and diode laser combination Each patient will be given pain scale chart (NRS scale) to record his/her pain level before any endodontic treatment. After disinfection, local anesthetic, tooth isolation, access cavity preparation and final obturation. Patients are asked to mark on a numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity at 6, 12, 24, 48, 72 hours, and 7 days after the procedure All data will be collected, tabulated, summarized, and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional group A | Active comparator | Drug: Conventional group |
| Dual laser group (Er,Cr:YSGG/Diode) | Experimental | Device: Dual laser group |
| Combined group (EDTA/Diode): | Experimental | Combination Product: Combined group |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients who had asymptomatic, single-rooted maxillary anterior teeth with necrotic pulp and periapical lesion with a periapical index score of 3 or 4
- Patients complaining of no pain and without fistulous tract
- Closed apex.
- Acceptance to participate in the study.
Key exclusion criteria (3 listed)
- Antibiotic use within the last month, anti-inflammatory analgesic use within the last 5 d, systemic diseases or allergic reactions, calcified canals, root resorption, previous root canal treatment.
- Periodontal diseases, presence of swelling or fistulous tract.
- Vulnerable group including pregnant females, mentally or physically disabled individuals. - Technical difficulties during root canal treatment such as; curved roots, broken files, over instrumentation, overfilling or incomplete filling.
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 |
|---|---|---|
| Conventional groupAlso: (NaOCl/EDTA)conventional disinfection using 2.5% sodium hypochlorite and 17% EDTA | Drug | Conventional group A |
| Dual laser groupAlso: (Er,Cr:YSGG/Diode)Er,Cr:YSGG intracanal laser irradiation to remove smear layer followed by diode laser for disinfection | Device | Dual laser group (Er,Cr:YSGG/Diode) |
| Combined groupAlso: (EDTA/Diode)17% EDTA was used to remove smear layer followed by diode laser for disinfection | Combination product | Combined group (EDTA/Diode): |
Primary outcome
Postoperative pain assessment
Time frame: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
Time frame: Measure changes in post-operative pain 12 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
Time frame: Measure changes in post-operative pain 24 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
Time frame: Measure changes in post-operative pain 48 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
Time frame: Measure changes in post-operative pain 72 hours after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
Postoperative pain assessment
Time frame: Measure changes in post-operative pain up to 7 days after intervention in the three groups using NRS
Patients will be asked to mark Numeric rating scale (NRS) to determine incidence of postoperative pain and rate its intensity. The NRS consisted of a line anchored by two extremes "No pain" and "the worst pain". * Pain level assigned to one of 4 categorical scores: * No pain (0), Mild (1-3), Moderate (4-6) and Severe (7-10).
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 30 Jun 2026.
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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 Phase 2 study testing Conventional group, Dual laser group and Combined group in people with Pulp Necroses and Apical Periodontitis, run by Future University in Egypt 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 3 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 30 Jun 2026. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain assessment (time frame: Measure changes in post-operative pain 6 hours after intervention in the three groups using NRS). The study lists 6 primary outcomes in all. 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 30 Jun 2026.