Postoperative PainNCT04594317
Effect of Low-level Laser Therapy Versus Calcium Hydroxide Intracanal Medication on Postoperative Pain and Substance P Levels in Patients With Symptomatic Apical Periodontitis
A study testing low level laser therapy in people with Postoperative Pain and Apical Periodontitis, run by Cairo University.
Trial summary
a randomized clinical study to compare the effect of using low level laser therapy versus calcium hydroxide intra-canal medication on: Incidence and intensity of postoperative pain in patients with symptomatic apical periodontitis. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Apical Periodontitis
- What is being tested?
- low level laser therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Jun 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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 25-50 years old.
- Males \& Females.
- Single canaled teeth:
- Diagnosed clinically with symptomatic apical periodontitis.
- Widening in the periodontal membrane space or with small sized periapical radiolucency
Show all 9Show fewer
- Presence of pain with percussion and preoperative percussion pain level will be evaluated and recorded using modified visual analog scale (VAS).
- Patients' acceptance to participate in the trial.
- Patients who can understand pain scale and can sign the informed consent
Who cannot join
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
- Greater than grade I mobility or pocket depth greater than 5mm. Need special surgical and/or periodontal therapy.
Show all 9Show fewer
- No restorability: Hopeless tooth.
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification.
About this study
Official title: Effect of Low Level Laser Therapy (LLLT) Versus Calcium Hydroxide Intra-canal Medication on Postoperative Pain and Total Amount of Substance P and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: a Randomized Clinical Trial
a randomized clinical study to compare the effect of using low level laser therapy versus calcium hydroxide intra-canal medication on:
- Incidence and intensity of postoperative pain in patients with symptomatic apical periodontitis.
- The intensity of postoperative percussion pain in patients with symptomatic apical periodontitis
- The total amount of substance P and Interleukin 8 in periapical fluids one week post instrumentation.
Read the detailed description
Diagnosis:
Personal data including name, address and phone number in addition to medical history (Appendix II) and dental history (Appendix III) will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken using bisecting angle technique with a periapical digital sensor plate1. The radiograph will help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
The diagnosis of symptomatic apical periodontitis is confirmed through:
- The patient history of pain with biting and confirmed with positive percussion test.
- After completing the diagnosis (symptomatic apical periodontitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in two visits.
Treatment procedure:
After diagnosing the case as symptomatic apical periodontitis and confirming that the patient conforms to all eligibility criteria, patients will be enrolled in in the study. Preoperative percussion pain level will be recorded using modified VAS. Treatment of all cases will be completed in two visits.
- Anesthetizing the tooth using infiltration technique by local anesthesia of 1.8 ml of 4% Articiane with 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall,Spain)
- Caries and/or coronal restorations will be removed completely with sterile bur and rubber dam will be applied.
- Operative field, including the tooth, the clamp, and rubber dam sheet will be cleaned with 30% hydrogen peroxide until no further bubbling of the peroxide occurred. All surfaces will then be disinfected by a sterile cotton swab with a 5.25% sodium hypochlorite solution.
- Access cavity will be prepared using another sterile round carbide bur size 3 and Endo-z bur(Dentsply Maillefer, Ballaigues, Switzerland)
- After completing the access, the operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above. NaOCl will be then neutralized with 5% sodium thiosulfate.
- Patency of the root canal will be confirmed using stainless steel handK-files size #10 and #15(K-Files, MANI, INC., Industrial Park, Utsunomiya, Tochigi, Japan).Working length will be determined using an electronic apex locator(Root ZX, J. Morita USA, Irvine, CA)then confirmed radiographically to be 1 mm shorter than radiographic apex. Then the canal will be enlarged to size #20.
- Mechanical preparation will be done using M PRO rotary files in an endodontic motor(X-Smart, Dentsply Maillefer, USA). The first file (18/.09) will be used as an orifice opener for two thirds of the working length followed by (20/.04) and (25/.06) for the full working length and finally (35/.06). In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established WL. The first file is used with a continuous rotary motion at a speed of 500rpm and torque of 3Ncm. The second, third and fourth files are used with a speed of 300 rpm and torque of 1.5Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- The canal will be thoroughly irrigated with 2.5% sodium hypochlorite root canal irrigant (5ml for 1 min) using disposable plastic syringe with side vented needle gauge 30 (Steri irrigation tips; Diadent, Chungcheongbuk-do, Korea) reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (5 ml prior to instrumentation, 5 ml between each file and 5 ml as final flush after root canal instrumentation to reach a total volume of 25 ml in total).
- The canal will then be dried by using sterile paper points(Meta Biomed Co., Ltd, Korea) and then flushed with 5 ml of saline to inactivate the NaOCl. The postinstrumentation periapical sample (PS-1) will be collected after cleaning and shaping by introducing a fine sterile size 20 paper point 2 mm beyond the canal terminus for 1 min.This procedure will be performed twice. The paper points will be placed in a sterile micro-centrifugation tube (Merck) containing 2 mL of sterile physiological saline solution, and immediately transferred to a -80 °C freezer until further processing.
- The patients will then be assigned into two groups (n = 23), as follows:
- LLLT Group: 970 ± 15-nm diode laser (Biolase Epic X, Biolase, Irvine, California, USA)will be activated at 0.5 W and 10 Hz at a distance of approximately 10 mm to the tissue around the apex of the root. A circular movement will be performed during the application. Pulse duration will be 0.5 s, and pulse pause will be 50%. Total application time will be30 s for the tooth. For this application, a 200-μm optical tip will be used.
- Calcium hydroxide Group: calcium hydroxide paste (Metapaste, Meta Biomed Co., Ltd, Korea) will be inserted in the canal using disposable plastic tip and placed at a distance 1 or 2 mm less than the working length.
- The access cavity will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- The patients will record the incidence of pain and the pain level on modified VAS scale at 6,12, 24 and48 hours
- In the recall appointment after 1 week. Rubber dam will be applied and tooth will be disinfected as before. The previously sampled canal will be re-entered, flushed with copious saline irrigation and a second periapical sample (PS-2) will be taken. After the sampling, final flush with 2.5% NaOCL and 17% EDTA will be done in both groups. Master cones of (0.40) taper gutta-percha(Meta Biomed Co., Ltd, Korea) will be fitted to the working length and a radiograph will be taken to ensure proper length. Obturation will be done by modified single cone technique using epoxy resin sealer(Adseal, Meta Biomed CO.,LTD, Korea)and 4% taper gutta percha cones together with auxillary cones.
- The access cavity will be restored with composite resin and occlusal contact will be checked. The details of the endodontic procedure for each patient will be recorded in the patient's procedure chart
- Conditions
- Postoperative Pain, Apical Periodontitis
- Being tested
- low level laser therapy
- Keywords
- low level laser therapy, calcium hydroxide, postoperative pain, biomarker, substance P, interleukin 8
- Medical subject headings
- Pain, Postoperative, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyDevice
buccal application of diode laser on non-contact mode
| Study group | Role | What they receive |
|---|---|---|
| low level laser therapy | Experimental | 970 ± 15-nm diode laser (Biolase Epic X, Biolase, Irvine, California, USA)will be activated at 0.5 W and 10 Hz at a distance of approximately 10 mm to the tissue around the apex of the root. A circular movement will be performed during application. Pulse duration will be 0.5 s, and pulse pause will be 50%. Total application time will be30 s for the tooth. For this application, a 200-μm optical tip will be used. Receives: Device: low level laser therapy |
| Calcium hydroxide intracanal medication | Active comparator | calcium hydroxide paste (Metapaste, Meta Biomed Co., Ltd, Korea) will be inserted in the canal using disposable plastic tip and placed at a distance 1 or 2 mm less than the working length. Receives: Device: low level laser therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative pain
incidence of postoperative pain will be recorded in pain chart
Measured: 24 hours
Secondary outcomes (1)
intensity of postoperative pain: modified visual analogue scale
intensity of postoperative pain will be recorded using modified visual analogue scale ( it's a scale from 0-10 , in which 0 represents lowest pain level with NO pain and 10 represents the highest pain level).
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 posted20 Oct 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized parallel clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radhwa Refaat Otaify, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594317
- Sponsor's protocol ID
- ENDO 3/3/5
- Status last verified
- Jan 2021
- First submitted
- 13 Oct 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still to decide whether to share it or not
Publications
Otaify RR, Abouelenien SS, Ghoneim AG, Shaker OG. Effect of low-level laser therapy versus calcium hydroxide intra-canal medication on postoperative pain and inflammatory mediator reduction in symptomatic apical periodontitis: a randomized clinical trial. BMC Oral Health. 2026 May 25;26(1):932. doi: 10.1186/s12903-026-08642-7.
PubMed 42186077
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Level Laser Therapy (LLLT) Versus Calcium Hydroxide Intra-canal Medication on Postoperative Pain and Total Amount of Substance P and IL-8 in Periapical Fluids in Patients With Symptomatic Apical Periodontitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04594317
- Acronym / sponsor ID
- ENDO 3/3/5
- Conditions
- Postoperative Pain, Apical Periodontitis
- Keywords
- low level laser therapy, calcium hydroxide, postoperative pain, biomarker, substance P, interleukin 8
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 20 Oct 2020 (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 study to compare the effect of using low level laser therapy versus calcium hydroxide intra-canal medication on:
- Incidence and intensity of postoperative pain in patients with symptomatic apical periodontitis.
- The intensity of postoperative percussion pain in patients with symptomatic apical periodontitis
- The total amount of substance P and Interleukin 8 in periapical fluids one week post instrumentation.
Detailed description
Diagnosis:
Personal data including name, address and phone number in addition to medical history (Appendix II) and dental history (Appendix III) will be collected by the operator from each patient in specific forms, then history of chief complaint will be recorded. The selected patients should show symptoms of irreversible pulpitis. The operator will perform extra-oral and intra-oral clinical examination as the expected tooth to be included in this study should be examined tentatively using a diagnostic mirror and probe. Radiograph will be taken using bisecting angle technique with a periapical digital sensor plate1. The radiograph will help to identify if there is widening of periodontal ligament space, periapical radiolucency, deep caries near the pulp chamber or recurrent caries under restoration.
The diagnosis of symptomatic apical periodontitis is confirmed through:
- The patient history of pain with biting and confirmed with positive percussion test.
- After completing the diagnosis (symptomatic apical periodontitis) and confirming that the patient fulfills the eligibility criteria, the patient will be enrolled in the study. The treatment will be done in two visits.
Treatment procedure:
After diagnosing the case as symptomatic apical periodontitis and confirming that the patient conforms to all eligibility criteria, patients will be enrolled in in the study. Preoperative percussion pain level will be recorded using modified VAS. Treatment of all cases will be completed in two visits.
- Anesthetizing the tooth using infiltration technique by local anesthesia of 1.8 ml of 4% Articiane with 1:100,000 epinephrine (Artinibsa®; Inibsa Dental, Lliçà de Vall,Spain)
- Caries and/or coronal restorations will be removed completely with sterile bur and rubber dam will be applied.
- Operative field, including the tooth, the clamp, and rubber dam sheet will be cleaned with 30% hydrogen peroxide until no further bubbling of the peroxide occurred. All surfaces will then be disinfected by a sterile cotton swab with a 5.25% sodium hypochlorite solution.
- Access cavity will be prepared using another sterile round carbide bur size 3 and Endo-z bur(Dentsply Maillefer, Ballaigues, Switzerland)
- After completing the access, the operative field and the pulp chamber will be cleaned and disinfected once again in the same way mentioned above. NaOCl will be then neutralized with 5% sodium thiosulfate.
- Patency of the root canal will be confirmed using stainless steel handK-files size #10 and #15(K-Files, MANI, INC., Industrial Park, Utsunomiya, Tochigi, Japan).Working length will be determined using an electronic apex locator(Root ZX, J. Morita USA, Irvine, CA)then confirmed radiographically to be 1 mm shorter than radiographic apex. Then the canal will be enlarged to size #20.
- Mechanical preparation will be done using M PRO rotary files in an endodontic motor(X-Smart, Dentsply Maillefer, USA). The first file (18/.09) will be used as an orifice opener for two thirds of the working length followed by (20/.04) and (25/.06) for the full working length and finally (35/.06). In-and-out motions will be applied with stroke lengths not exceeding 3 mm in the cervical, middle, and apical thirds until attaining the established WL. The first file is used with a continuous rotary motion at a speed of 500rpm and torque of 3Ncm. The second, third and fourth files are used with a speed of 300 rpm and torque of 1.5Ncm. The canal will be irrigated and recapitulated after the use of each instrument.
- The canal will be thoroughly irrigated with 2.5% sodium hypochlorite root canal irrigant (5ml for 1 min) using disposable plastic syringe with side vented needle gauge 30 (Steri irrigation tips; Diadent, Chungcheongbuk-do, Korea) reaching 1 mm short of the working length. All teeth will receive the same volume of irrigant (5 ml prior to instrumentation, 5 ml between each file and 5 ml as final flush after root canal instrumentation to reach a total volume of 25 ml in total).
- The canal will then be dried by using sterile paper points(Meta Biomed Co., Ltd, Korea) and then flushed with 5 ml of saline to inactivate the NaOCl. The postinstrumentation periapical sample (PS-1) will be collected after cleaning and shaping by introducing a fine sterile size 20 paper point 2 mm beyond the canal terminus for 1 min.This procedure will be performed twice. The paper points will be placed in a sterile micro-centrifugation tube (Merck) containing 2 mL of sterile physiological saline solution, and immediately transferred to a -80 °C freezer until further processing.
- The patients will then be assigned into two groups (n = 23), as follows:
- LLLT Group: 970 ± 15-nm diode laser (Biolase Epic X, Biolase, Irvine, California, USA)will be activated at 0.5 W and 10 Hz at a distance of approximately 10 mm to the tissue around the apex of the root. A circular movement will be performed during the application. Pulse duration will be 0.5 s, and pulse pause will be 50%. Total application time will be30 s for the tooth. For this application, a 200-μm optical tip will be used.
- Calcium hydroxide Group: calcium hydroxide paste (Metapaste, Meta Biomed Co., Ltd, Korea) will be inserted in the canal using disposable plastic tip and placed at a distance 1 or 2 mm less than the working length.
- The access cavity will be closed using sterile cotton pellet and temporary filling and patients will be recalled after 1 week.
- The patients will record the incidence of pain and the pain level on modified VAS scale at 6,12, 24 and48 hours
- In the recall appointment after 1 week. Rubber dam will be applied and tooth will be disinfected as before. The previously sampled canal will be re-entered, flushed with copious saline irrigation and a second periapical sample (PS-2) will be taken. After the sampling, final flush with 2.5% NaOCL and 17% EDTA will be done in both groups. Master cones of (0.40) taper gutta-percha(Meta Biomed Co., Ltd, Korea) will be fitted to the working length and a radiograph will be taken to ensure proper length. Obturation will be done by modified single cone technique using epoxy resin sealer(Adseal, Meta Biomed CO.,LTD, Korea)and 4% taper gutta percha cones together with auxillary cones.
- The access cavity will be restored with composite resin and occlusal contact will be checked. The details of the endodontic procedure for each patient will be recorded in the patient's procedure chart
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized parallel clinical trial
| Arm | Type | Receives |
|---|---|---|
| low level laser therapy | Experimental | Device: low level laser therapy970 ± 15-nm diode laser (Biolase Epic X, Biolase, Irvine, California, USA)will be activated at 0.5 W and 10 Hz at a distance of approximately 10 mm to the tissue around the apex of the root. A circular movement will be performed during application. Pulse duration will be 0.5 s, and pulse pause will be 50%. Total application time will be30 s for the tooth. For this application, a 200-μm optical tip will be used. |
| Calcium hydroxide intracanal medication | Active comparator | Device: low level laser therapycalcium hydroxide paste (Metapaste, Meta Biomed Co., Ltd, Korea) will be inserted in the canal using disposable plastic tip and placed at a distance 1 or 2 mm less than the working length. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Patients who are free from any physical or mental handicapping condition with no underlying systemic disease.
- Age between 25-50 years old.
- Males \& Females.
- Single canaled teeth:
- Patients' acceptance to participate in the trial.
Key exclusion criteria (9 listed)
- Medically compromised patients: Pain levels and healing following treatment would be compromised as these patients have shown higher incidence of pain and lower healing rate.
- Pregnant women: Avoid radiation exposure, anesthesia, and medication.
- If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively might alter their pain perception.
- Patients reporting bruxism or clenching: Avoid further pressure on an already inflamed tooth inducing subsequent irritation and inflammation.
- Teeth that shows association with acute periapical abscess and swelling: Need special treatment steps which could involve additional visits with incision and drainage. Also, it could influence initiation and progression of postoperative pain.
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 therapybuccal application of diode laser on non-contact mode | Device | Calcium hydroxide intracanal medication, low level laser therapy |
Primary outcome
incidence of postoperative pain
Time frame: 24 hours
incidence of postoperative pain will be recorded in pain chart
1 secondary outcome
intensity of postoperative pain: modified visual analogue scale
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 26 Jan 2021.
- Derived from this study: PubMed 42186077Otaify RR, Abouelenien SS, Ghoneim AG, Shaker OG. Effect of low-level laser therapy versus calcium hydroxide intra-canal medication on postoperative pain and inflammatory mediator reduction in symptomatic apical periodontitis: a randomized clinical trial. BMC Oral Health. 2026 May 25;26(1):932. doi: 10.1186/s12903-026-08642-7.
- Individual participant dataSharing planned: Undecided. Still to decide whether to share it or not
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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 low level laser therapy in people with Postoperative Pain and Apical Periodontitis, 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 9 inclusion and 9 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 26 Jan 2021. 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. 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?
incidence of postoperative pain (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04594317, which also lists 1 linked publication.
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 26 Jan 2021.