Necrotic Pulp With Symptomatic Apical PeriodontitisPhase 4NCT05021809
Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication .
A Phase 4 study testing Calcium hydroxide intracanal medication application in people with Necrotic Pulp With Symptomatic Apical Periodontitis, run by Suez Canal University at 1 site in Egypt.
Trial summary
Calcium hydroxide is advocated as an intracanal medication for various purposes, including prevention of post-treatment symptoms. Calcium hydroxide has a pain-controlling effect at different times when compared to non-intracanal medication . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Necrotic Pulp With Symptomatic Apical Periodontitis
- What is being tested?
- Calcium hydroxide intracanal medication application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Jul 2021to Nov 2022
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .single-rooted teeth with pulpal necrosis and symptomatic apical periodontitis with visible radiographic disturbance of periapical lamina dura. The diagnosis of pulp necrosis was confirmed by negative response to cold test, electric pulp tester and clinically by absence of blood upon access cavity .
- Clinical signs of apical periodontitis.
- Teeth with sufficient coronal tooth structure for adequate rubber dam isolation were selected .
- Patients who are over 18 years old .
Who cannot join
- Presence of open apices
- Presence of non-restorable teeth
- Presence of large carious lesions approaching the root.
- Presence of calcification or resorption .
- Patients who had received antibiotics during the last 3 months .
- Teeth with periodontal probing depth > 4 ml.
Show all 9Show fewer
- Teeth with previous root canal treatment .
- Teeth with fluctuant facial swelling .
- Pregnant females.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Endodontic Clinic At Faculty of Dentistry ,Suez Canal University
Ismailia, 41511
sarah ad elabyad, bachelors, 01008922535 ext. +2, dr.saraelabyad@gmail.com
nelly mo abdelsalam, phd, 01006623416 ext. +2, nelly_mohamed@dent.suez.edu.eg
About this study
Official title: Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication : A Randomized Clinical Trial.
Calcium hydroxide is advocated as an intracanal medication for various purposes, including prevention of post-treatment symptoms. Calcium hydroxide has a pain-controlling effect at different times when compared to non-intracanal medication .
Aim:
The aim of the study to compare between postoperative pain after using two formulations of calcium hydroxide intracanal medication with and without iodoform .
Read the detailed description
The most persuasive factor for a patient to visit a dental health care professional is the existence of odontalgia. Accordingly, the pain after a dental therapy results in demotivation of the patient. Unfortunately, mild to severe pain following a tooth-preserving therapy such as root canal treatment is reported to be experienced by 40% of the patients.
The majority of patients with symptomatic necrotic teeth had significant postoperative pain and required analgesic medication to manage this pain.
There is a correlation between the intensity of preoperative pain and postoperative pain ,The preoperative pain has a significant influence on postoperative pain.
Several strategies are suggested to manage or prevent post instrumentation pain. One of them is insertion of intracanal medicament.
The interappointment intracanal medicaments are suggested for disinfection of the infected root canal system in multi-visit endodontic treatment. Calcium hydroxide (Ca(OH)2) is considered as a universal intracanal medicament for this purpose.
Additionally, calcium hydroxide is hypothesized to exert a pain-preventing effect indirectly through its antimicrobial and tissue modifying properties .
Significantly high healing rates have been shown with short term use of calcium hydroxide Ca(OH)2 in teeth with apical periodontitis. As a temporary root filling, it has been shown to be an effective antimicrobial agent when applied for a minimum of 1 week.
Calcium hydroxide is a suitable material of choice as an inter-appointment dressing for teeth diagnosed with pulpal necrosis and apical periodontitis.
Calcium hydroxide reduced pain risk than no intracanal medication within the 1-14 days interval as well as triple-antibiotic paste within the first day and was similar to corticosteroid/antibiotics combination.
Iodoform has bacteriostatic property by releasing free iodine.Thereby, iodine eliminates the infection of root canal and periapical tissue by precipitating protein and oxidizes essential enzymes.
The use of calcium hydroxide-iodoform-silicon-oil paste as nonsurgical approach for treatment of periapical lesions showed a high success rate.
As clinicians , one of the most important goals to achieve is reducing the pain of the patient. Up to our knowledge, none of the previous studies investigated the postoperative pain incidence after application of Ca(OH)2 with iodoform as an intracanal medication .
- Being tested
- Calcium hydroxide intracanal medication application
- Keywords
- pulp necrosis, symptomatic apical periodontitis, calcium hydroxide intracanal medication, postoperative pain, calcium hydroxide with iodoform, calcium hydroxide without iodoform
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium hydroxide intracanal medication applicationDrug
The patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied .
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | control group will not receive any intracanal medication |
| Group B | Active comparator | Calcium hydroxide intracanal medication without iodoform (Metapaste ) Receives: Drug: Calcium hydroxide intracanal medication application |
| Group C | Active comparator | Calcium hydroxide intracanal medication with iodoform (Metapex) Receives: Drug: Calcium hydroxide intracanal medication application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 4 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 4 hours .
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 6 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 6 hours.
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 12 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 12 hours .
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 24 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 24 hours .
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 48 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 48 hours .
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 72 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded at 72 hours .
Measuring the severity of postoperative pain in both groups.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded after one week . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measured: The pain score will be recorded after one week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start25 Jul 2021
- Primary completionSep 2022 (estimated)
- Study completionNov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Necrotic Pulp With Symptomatic Apical PeriodontitisStudies of the same condition, open and under way.
- More trials run by Suez Canal 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Alaa El Din Mohamed Hamed El Abyad, Suez Canal University
- Investigators
- marwa es sharaan, PHD, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021809
- Sponsor's protocol ID
- 360/2021
- Status last verified
- Feb 2022
- First submitted
- 16 Aug 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided yet
Publications
Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.
PubMed 14606782Sebastian R, Drum M, Reader A, Nusstein J, Fowler S, Beck M. What is the Effect of No Endodontic Debridement on Postoperative Pain for Symptomatic Teeth with Pulpal Necrosis? J Endod. 2016 Mar;42(3):378-82. doi: 10.1016/j.joen.2015.12.001. Epub 2016 Jan 20.
PubMed 26806591Madarati AA, Zafar MS, Sammani AMN, Mandorah AO, Bani-Younes HA. Preference and usage of intracanal medications during endodontic treatment. Saudi Med J. 2017 Jul;38(7):755-763. doi: 10.15537/smj.2017.7.18345.
PubMed 28674723
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Postoperative Pain After Using Two Formulations of Calcium Hydroxide Intracanal Medication : A Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05021809
- Acronym / sponsor ID
- 360/2021
- Keywords
- pulp necrosis, symptomatic apical periodontitis, calcium hydroxide intracanal medication, postoperative pain, calcium hydroxide with iodoform, calcium hydroxide without iodoform
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 26 Aug 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.
Calcium hydroxide is advocated as an intracanal medication for various purposes, including prevention of post-treatment symptoms. Calcium hydroxide has a pain-controlling effect at different times when compared to non-intracanal medication .
Aim:
The aim of the study to compare between postoperative pain after using two formulations of calcium hydroxide intracanal medication with and without iodoform .
Detailed description
The most persuasive factor for a patient to visit a dental health care professional is the existence of odontalgia. Accordingly, the pain after a dental therapy results in demotivation of the patient. Unfortunately, mild to severe pain following a tooth-preserving therapy such as root canal treatment is reported to be experienced by 40% of the patients.
The majority of patients with symptomatic necrotic teeth had significant postoperative pain and required analgesic medication to manage this pain.
There is a correlation between the intensity of preoperative pain and postoperative pain ,The preoperative pain has a significant influence on postoperative pain.
Several strategies are suggested to manage or prevent post instrumentation pain. One of them is insertion of intracanal medicament.
The interappointment intracanal medicaments are suggested for disinfection of the infected root canal system in multi-visit endodontic treatment. Calcium hydroxide (Ca(OH)2) is considered as a universal intracanal medicament for this purpose.
Additionally, calcium hydroxide is hypothesized to exert a pain-preventing effect indirectly through its antimicrobial and tissue modifying properties .
Significantly high healing rates have been shown with short term use of calcium hydroxide Ca(OH)2 in teeth with apical periodontitis. As a temporary root filling, it has been shown to be an effective antimicrobial agent when applied for a minimum of 1 week.
Calcium hydroxide is a suitable material of choice as an inter-appointment dressing for teeth diagnosed with pulpal necrosis and apical periodontitis.
Calcium hydroxide reduced pain risk than no intracanal medication within the 1-14 days interval as well as triple-antibiotic paste within the first day and was similar to corticosteroid/antibiotics combination.
Iodoform has bacteriostatic property by releasing free iodine.Thereby, iodine eliminates the infection of root canal and periapical tissue by precipitating protein and oxidizes essential enzymes.
The use of calcium hydroxide-iodoform-silicon-oil paste as nonsurgical approach for treatment of periapical lesions showed a high success rate.
As clinicians , one of the most important goals to achieve is reducing the pain of the patient. Up to our knowledge, none of the previous studies investigated the postoperative pain incidence after application of Ca(OH)2 with iodoform as an intracanal medication .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –control group will not receive any intracanal medication |
| Group B | Active comparator | Drug: Calcium hydroxide intracanal medication applicationCalcium hydroxide intracanal medication without iodoform (Metapaste ) |
| Group C | Active comparator | Drug: Calcium hydroxide intracanal medication applicationCalcium hydroxide intracanal medication with iodoform (Metapex) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- .single-rooted teeth with pulpal necrosis and symptomatic apical periodontitis with visible radiographic disturbance of periapical lamina dura. The diagnosis of pulp necrosis was confirmed by negative response to cold test, electric pulp tester and clinically by absence of blood upon access cavity .
- Clinical signs of apical periodontitis.
- Teeth with sufficient coronal tooth structure for adequate rubber dam isolation were selected .
- Patients who are over 18 years old .
Key exclusion criteria (9 listed)
- Presence of open apices
- Presence of non-restorable teeth
- Presence of large carious lesions approaching the root.
- Presence of calcification or resorption .
- Patients who had received antibiotics during the last 3 months .
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 |
|---|---|---|
| Calcium hydroxide intracanal medication applicationThe patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied . | Drug | Group B, Group C |
Primary outcome
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 4 hours .
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 4 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 6 hours.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 6 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 12 hours .
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 12 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 24 hours .
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 24 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 48 hours .
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 48 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded at 72 hours .
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded at 72 hours . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Measuring the severity of postoperative pain in both groups.
Time frame: The pain score will be recorded after one week.
Measuring the severity of postoperative pain in both groups. The patients will be informed to record their pain scores in visual analogue scale (VAS) as used by Habib et al. (1990) .The degree of the pain will have numerical value 0= no pain, 1-3= mild pain, 4-6= moderate pain , 7-9= severe pain . The pain score will be recorded after one week . No medication will be prescribed for the patients . They will be instructed to take only Ibuprofen if they experienced pain and it will be recorded in the chart.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Background: PubMed 14606782Walton RE, Holton IF Jr, Michelich R. Calcium hydroxide as an intracanal medication: effect on posttreatment pain. J Endod. 2003 Oct;29(10):627-9. doi: 10.1097/00004770-200310000-00003.
- Background: PubMed 26806591Sebastian R, Drum M, Reader A, Nusstein J, Fowler S, Beck M. What is the Effect of No Endodontic Debridement on Postoperative Pain for Symptomatic Teeth with Pulpal Necrosis? J Endod. 2016 Mar;42(3):378-82. doi: 10.1016/j.joen.2015.12.001. Epub 2016 Jan 20.
- Background: PubMed 28674723Madarati AA, Zafar MS, Sammani AMN, Mandorah AO, Bani-Younes HA. Preference and usage of intracanal medications during endodontic treatment. Saudi Med J. 2017 Jul;38(7):755-763. doi: 10.15537/smj.2017.7.18345.
- Individual participant dataSharing planned: Undecided. undecided yet
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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.
marwa es sharaan, PHD principal investigator
Suez Canal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium hydroxide intracanal medication application in people with Necrotic Pulp With Symptomatic Apical Periodontitis, run by Suez Canal 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 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 22 Mar 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sarah ad elabyad, bachelors (01008922535 ext. +2, dr.saraelabyad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the severity of postoperative pain in both groups. (time frame: The pain score will be recorded at 4 hours .). The study lists 7 primary outcomes in all. 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 NCT05021809, which also lists 3 linked publications.
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 22 Mar 2022.