Class II Division 1 MalocclusionNCT05040945
Evaluation of the Levels of Pain and Discomfort Associated With Two Techniques of Corticotomy
A study testing Traditional corticotomy and Flapless corticotomy in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Traditional corticotomy and Flapless corticotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSyria
- Study dates
- 15 Feb 2018to 15 May 2019
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range between 18 and 30 years.
- Class II division 1 malocclusion requiring extraction of upper first premolars.
- Mild to moderate skeletal class II malocclusion.
- Normal or excessive anterior facial height.
- No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
- Overjet >5 mm and <10 mm.
Show all 10Show fewer
- Completion permanent dentition (regardless of third molars).
- No previous orthodontic treatment.
- No drug use or systematic disease that would affect the bone and tooth movement rate.
- Healthy periodontium and good oral hygiene.
Who cannot join
- Patients with previous orthodontic treatment.
- Patients with severe skeletal dysplasia in all three dimensions.
- Patients suffer from systemic diseases or syndromes
- Patients on medication for systemic disorders, pregnancy or steroid therapy.
- Patients showing any signs of active periodontal disease
- Patients with severe crowding (≥ 3.5 mm) in maxillary arch
- Patients with missing or extracted teeth in maxillary arch except third molar.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus
About this study
Official title: Evaluation of the Levels of Pain and Discomfort Associated With Traditional or Flapless Corticotomy-assisted Maxillary En-masse Retraction: a Single- Center, Randomized Controlled Clinical Trial
This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy.
Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.
Read the detailed description
Increasing the treatment duration is one of the most important difficulties facing the orthodontist. Several therapeutic procedures accompanying orthodontic treatment have been introduced in order to reduce the treatment duration and the most important one is the corticotomy. Although traditional corticotomy proved to be effective in accelerating different types of tooth movement, it is considered aggressive in nature. Hence, there is an interest to develop minimally invasive surgical techniques. These techniques include the flapless corticotomy using the piezosurgery device.
In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and second premolars. The incisions will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm in length. No suturing will be needed.
In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated, extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. The full-thickness flap will be extended 3 mm above the root apices, from the buccal and palatal sides. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. The vertical incisions will be connected by a horizontal incision using the piezosurgery knives. The vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and extending 3 mm beyond the root apices. The interrupted technique of suturing will be done using a non-absorbent 3-0 black silk.
The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire based on the Visual Analogue Scale (VAS), and patient's responses will be obtained regarding their feelings of pain, discomfort, swelling, mastication and swallowing difficulties, jaw movement restriction, satisfaction and recommend the procedure to a friend.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Traditional corticotomy, Flapless corticotomy
- Keywords
- Pain and discomfort, En-masse, Class II division 1, Extraction, Tooth movement acceleration, Traditional corticotomy, Fapless corticotomy, Mini-screws
- Medical subject headings
- Malocclusion, Angle Class II, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional corticotomyProcedure or surgery
Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied.
Flapless corticotomyProcedure or surgery
Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Traditional corticotomy | Active comparator | Adult patients will be treated by en-masse retraction associated with traditional corticotomy Receives: Procedure: Traditional corticotomy |
| Flapless corticotomy | Experimental | Adult patients will be treated by en-masse retraction associated with flapless corticotomy Receives: Procedure: Flapless corticotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the levels of pain perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain).
Measured: Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of discomfort perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort)
Measured: Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Secondary outcomes (7)
Change in the levels of swelling perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Measured: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of mastication difficulty perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Measured: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of swallowing difficulty perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Measured: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of Jaw movement restriction perception
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Measured: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
The levels of satisfaction
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question
Measured: This outcome will be assessed after four weeks following the surgical intervention
Which surgical intervention is more troublesome
Assessment will be performed using a three-point scale:
- premolar extraction.
- Corticotomy procedure.
- Both of them are similar.
Measured: This outcome will be assessed after four weeks following the surgical intervention
Recommendation of the procedure to a friend
Assessment will be performed using a two-point scale to answer yes or no
Measured: This outcome will be assessed after four weeks following the surgical intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start15 Feb 2018
- Primary completion31 Jul 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Class II Division 1 MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanin Nizar Khlef, DDS,MSc, Principal investigator, Specialist and Clinical Lecturer, Department of Orthodontics, University of DamascusMohammad Y Hajeer, DDS,MSc,PhD, Study chair, Professor of Orthodontics, University of Damascus Dental School, Damascus, SyriaOmar Heshmeh, DDS,MSc,PhD, Study director, Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05040945
- Sponsor's protocol ID
- UDDS-Ortho-08-2021
- Status last verified
- Sep 2021
- First submitted
- 2 Sep 2021
- Last updated
- 10 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PubMed 23787192Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127.
PubMed 31058623Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
PubMed 32909702Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
PubMed 30991984Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.
PubMed 33158633
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Levels of Pain and Discomfort Associated With Traditional or Flapless Corticotomy-assisted Maxillary En-masse Retraction: a Single- Center, Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05040945
- Acronym / sponsor ID
- UDDS-Ortho-08-2021
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Pain and discomfort, En-masse, Class II division 1, Extraction, Tooth movement acceleration, Traditional corticotomy, Fapless corticotomy, Mini-screws
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 10 Sep 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.
This study aims to estimate the levels of pain and discomfort associated with the en-masse retraction of the six upper anterior teeth and assisted by either conventional or flapless corticotomy.
Thirty-four adult patients exhibiting class П division 1 malocclusion will be randomly allocated to either the conventional corticotomy group or the flapless corticotomy group, and they will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire for assessing levels of pain and discomfort.
Detailed description
Increasing the treatment duration is one of the most important difficulties facing the orthodontist. Several therapeutic procedures accompanying orthodontic treatment have been introduced in order to reduce the treatment duration and the most important one is the corticotomy. Although traditional corticotomy proved to be effective in accelerating different types of tooth movement, it is considered aggressive in nature. Hence, there is an interest to develop minimally invasive surgical techniques. These techniques include the flapless corticotomy using the piezosurgery device.
In flapless corticotomy group, vertical soft-tissue incisions will be made on the buccal and palatal gingiva. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and second premolars. The incisions will be 5 mm long and started 4 mm apical to the interdental papilla. Then a piezosurgery knife will be inserted to perform the cortical alveolar incisions with 3-mm in-depth and 8-mm in length. No suturing will be needed.
In traditional corticotomy group, a full-thickness mucoperiosteal flap will be elevated, extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. The full-thickness flap will be extended 3 mm above the root apices, from the buccal and palatal sides. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife. The vertical incisions will be connected by a horizontal incision using the piezosurgery knives. The vertical incisions will be 3 mm in depth, starting 2-3 mm apical to the alveolar crest, and extending 3 mm beyond the root apices. The interrupted technique of suturing will be done using a non-absorbent 3-0 black silk.
The levels of pain and discomfort will be rated after 24 hours of corticotomy (T1), four days (T2), seven days (T3), 14 days (T4) and after 28 days of corticotomy, by asking the patients to fill in a questionnaire based on the Visual Analogue Scale (VAS), and patient's responses will be obtained regarding their feelings of pain, discomfort, swelling, mastication and swallowing difficulties, jaw movement restriction, satisfaction and recommend the procedure to a friend.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional corticotomy | Active comparator | Procedure: Traditional corticotomyAdult patients will be treated by en-masse retraction associated with traditional corticotomy |
| Flapless corticotomy | Experimental | Procedure: Flapless corticotomyAdult patients will be treated by en-masse retraction associated with flapless corticotomy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age range between 18 and 30 years.
- Class II division 1 malocclusion requiring extraction of upper first premolars.
- Mild to moderate skeletal class II malocclusion.
- Normal or excessive anterior facial height.
- No or mild crowding (tooth-size arch-length discrepancy ≤3 mm).
Key exclusion criteria (7 listed)
- Patients with previous orthodontic treatment.
- Patients with severe skeletal dysplasia in all three dimensions.
- Patients suffer from systemic diseases or syndromes
- Patients on medication for systemic disorders, pregnancy or steroid therapy.
- Patients showing any signs of active periodontal disease
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 |
|---|---|---|
| Traditional corticotomyAdult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied. | Procedure or surgery | Traditional corticotomy |
| Flapless corticotomyAdult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied. | Procedure or surgery | Flapless corticotomy |
Primary outcome
Change in the levels of pain perception
Time frame: Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no pain) and a maximum scale of 100 (maximum pain).
Change in the levels of discomfort perception
Time frame: Levels of discomfort perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Assessment will be performed using questionnaires via Visual Analog Scale (VAS) for each question.The scale has a minimum scale of 0 (no discomfort) and a maximum scale of 100 (maximum discomfort)
7 secondary outcomes
Change in the levels of swelling perception
Time frame: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of mastication difficulty perception
Time frame: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of swallowing difficulty perception
Time frame: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
Change in the levels of Jaw movement restriction perception
Time frame: This outcome will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention
The levels of satisfaction
Time frame: This outcome will be assessed after four weeks following the surgical intervention
Which surgical intervention is more troublesome
Time frame: This outcome will be assessed after four weeks following the surgical intervention
Recommendation of the procedure to a friend
Time frame: This outcome will be assessed after four weeks following the surgical intervention
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 10 Sep 2021.
- Background: PubMed 23787192Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- Background: PubMed 31058623Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O. En-masse Retraction of Upper Anterior Teeth in Adult Patients with Maxillary or Bimaxillary Dentoalveolar Protrusion: A Systematic Review and Meta-analysis. J Contemp Dent Pract. 2019 Jan 1;20(1):113-127.
- Background: PubMed 32909702Alfawal AMH, Hajeer MY, Ajaj MA, Hamadah O, Brad B, Latifeh Y. Evaluation of patient-centered outcomes associated with the acceleration of canine retraction by using minimally invasive surgical procedures: A randomized clinical controlled trial. Dent Med Probl. 2020 Jul-Sep;57(3):285-293. doi: 10.17219/dmp/120181.
- Background: PubMed 30991984Gibreal O, Hajeer MY, Brad B. Evaluation of the levels of pain and discomfort of piezocision-assisted flapless corticotomy when treating severely crowded lower anterior teeth: a single-center, randomized controlled clinical trial. BMC Oral Health. 2019 Apr 16;19(1):57. doi: 10.1186/s12903-019-0758-9.
- Background: PubMed 33158633Khlef HN, Hajeer MY, Ajaj MA, Heshmeh O, Youssef N, Mahaini L. The effectiveness of traditional corticotomy vs flapless corticotomy in miniscrew-supported en-masse retraction of maxillary anterior teeth in patients with Class II Division 1 malocclusion: A single-centered, randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2020 Dec;158(6):e111-e120. doi: 10.1016/j.ajodo.2020.08.008. Epub 2020 Nov 4.
- 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.
Hanin Nizar Khlef, DDS,MSc principal investigator
Specialist and Clinical Lecturer, Department of Orthodontics, University of Damascus
Mohammad Y Hajeer, DDS,MSc,PhD study chair
Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Omar Heshmeh, DDS,MSc,PhD study director
Professor of Oral and Maxillofacial Surgery, University of Damascus Dental School, Damascus, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional corticotomy and Flapless corticotomy in people with Class II Division 1 Malocclusion, run by Damascus University at 1 site in Syria.
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 10 inclusion and 7 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 10 Sep 2021. 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 Syria. 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.
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?
Change in the levels of pain perception (time frame: Levels of pain perception will be assessed at: 24 hours following the surgical intervention (T1), 4 days (T2), one week (T3), two weeks (T4), and four weeks (T5) following the surgical intervention). The study lists 2 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 NCT05040945, which also lists 5 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 10 Sep 2021.