Class II Division 1 MalocclusionNCT05928143
Patient Outcomes Associated With Two Accelerated Method of Retraction of Upper Front Teeth
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 aimed to evaluate the levels of pain, discomfort, and functional impairment associated with traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth. Read more about this study
- Who is it for?
- Ages 17 to 28 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
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 15 Feb 2018to 15 May 2020
- 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 17 to 28 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult healthy patients
- Class II Division 1 malocclusion :
- Mild/moderate skeletal Class II (sagittal discrepancy angle ≤7)
- Overjet ≤10
- Normal or excessive facial height (Clinically and then cephalometrically assessed using these three angles: mandibular/cranial base angle, maxillary/mandibular plane angle, and facial axis angle)
- Mild to moderate crowding ≤ 4
Show all 13Show fewer
- Permanent occlusion.
- Existence of all the upper teeth (except third molars).
- Good oral and periodontal health:
- Probing depth < 4 mm
- No radiographic evidence of bone loss.
- Gingival index ≤ 1
- Plaque index ≤ 1
Who cannot join
- Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs))
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
- radiographic evidence of bone loss
Show all 9Show fewer
- Gingival index > 1
- Plaque index > 1
- Previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Syria1 site
Orthodontics Department, Faculty of Dentistry, University of Damascus
Damascus, DM20AM19
About this study
Official title: Assessment of the Levels of Pain and Discomfort Associated With Corticotomy-assisted Retraction of the Anterior Maxillary Teeth Using Two Different Corticotomy Techniques. A Randomized Controlled Clinical Trial.
This study aimed to evaluate the levels of pain, discomfort, and functional impairment associated with traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth.
40 patients requiring extraction of maxillary first premolars and maximum anchorage to retract the upper anterior teeth will participate in the study. They will be divided randomly into two groups: flapless corticotomy (20 patients) and traditional corticotomy (20 patients).
Read the detailed description
A corticotomy is the cutting of the bone that involves cortical bone only, leaving intact the medullary vessels and periosteum. It offers an advantage to adult patients in reducing orthodontic treatment time. The definition of traditional corticotomy is: elevating full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth apices and connected by a horizontal corticotomy; this process is done on both the labial and palatal aspects.
The definition of flapless corticotomy is a minimally invasive version of corticotomy, using a piezotome to inflict bone injury. This technique entails labial and palatal interproximal piezoelectric micro-incisions into the cortical bone without reflecting periodontal flaps.
Before enrolling each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will be inserted between the maxillary second premolar and first molar at approximately 8-10mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be leveled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be inserted.
The surgery will be carried out under local anesthesia. The traditional corticotomy will be handled by the same maxillofacial surgeon, and the flapless corticotomy will be handled by the same orthodontist.
For traditional corticotomy, incisions in the mesial aspect of one-second premolar to the mesial surface of the contralateral second premolar will be placed, and a full-thickness flap will be elevated 3 mm above the apical region of the tooth. piezoelectric under copious irrigation will make vertical and horizontal cuts (only cortical surface). The vertical cuts will be between the dental roots in the interdental cortical surfaces, stopping 2 mm short of the alveolar crest occlusally. The horizontal cut will connect the vertical cuts 2 mm beyond the root apex. These cuts will be performed from the mesial aspect one-second premolar to the mesial surface of the contralateral second premolar involving the anterior. Similarly, a palatal flap incision will be raised immediately for doing the same vertical and horizontal cuts in the superficial surface of the palatal bone.
For the flapless corticotomy, the depth of gingival tissue will be determined through bone sounding using a periodontal probe. A scalpel will be used to make the incisions through the gingiva, 4mm below the interdental papilla, to preserve the coronal attached gingiva. These vertical incisions will be placed from the mesial aspect of the one-second premolar to the mesial surface of the contralateral second premolar on the labial and palatal aspects of the maxilla through the gingiva and the underlying bone. A piezo-surgery knife will be used to create the cortical alveolar incisions to a depth of 1 mm within the cortical bone.
The surgical procedure will be performed, and (250-300) g force will be applied on each side (3-4 days) after corticotomy using two Nickle-Titanium (NiTi) springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy. Retraction will be stopped when a class I canine relationship is achieved, and a good incisor relationship will be obtained.
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Traditional corticotomy, Flapless corticotomy
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Traditional corticotomyProcedure or surgery
A flap covering the alveolar process will be elevated. Perforations will be done using surgical burs, and then the flap will be returned, and sutures will be performed.
Flapless corticotomyProcedure or surgery
Some incisions will be made in the mucosa of the alveolar process. Then these incisions will allow the working head of the piezotome to cut the bone in grooves. The whole procedure will not require flap elevation and replacement.
| Study group | Role | What they receive |
|---|---|---|
| Traditional corticotomy | Active comparator | In this group, the acceleration procedure will be performed by elevating flaps and doing the surgical intervention directly using surgical burs. Receives: Procedure: Traditional corticotomy |
| Flapless corticotomy | Experimental | In this group, the acceleration procedure will be performed without elevating flaps, and the surgical intervention will be performed using a special device. 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
Patients will be asked this question about their feeling of pain (Item no 01): 'What is the degree of pain you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Change in the levels of discomfort
Patients will be asked this question about their feeling of discomfort: 'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no discomfort- 100: the worst discomfort). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Change in the perception of swelling
Patients will be asked this question about their feeling of swelling: 'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no swelling- 100: the worst swelling). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Change in the levels of chewing difficulty
'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: too much difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Change in the levels of swallowing difficulty
Patients will be asked this question about their feeling of swallowing: 'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: the worst difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Change in the levels of jaw movement restriction
Patients will be asked this question about their feeling about the jaw movement restriction: 'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no restriction- 100: maximum restriction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Level of satisfaction
Patients will be asked this question about their satisfaction level: 'What is your level of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no satisfaction- 100: the highest satisfaction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Measured: This outcome will be assessed at 28 days following the surgical intervention
The more discomfort procedure between two interventions
Patients will be asked this question: (Which surgical intervention was more discomfort ("extraction of premolars" or "the surgical procedure for acceleration"?) Assessment will be performed using a three-point scale: 1- premolar extraction, 2- surgical procedure, or 3-the same.
Measured: This outcome will be assessed at 28 days following the surgical intervention
The willingness to undergo this procedure again
Patients would be asked this question about the possibility of repeating the surgical procedure if they had to make the decision again: 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale: Yes/No.
Measured: This outcome will be assessed at 28 days 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 posted3 Jul 2023
- Study start15 Feb 2018
- Primary completion15 Oct 2019
- Study completion15 May 2020
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanin Khlef, DDS, MSc, Principal investigator, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928143
- Sponsor's protocol ID
- UDDS-Ortho-12-2023
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alfawal 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 32909702Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.
PubMed 35796046Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
PubMed 27129491Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
PubMed 24326120Gibreal 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 30991984
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Levels of Pain and Discomfort Associated With Corticotomy-assisted Retraction of the Anterior Maxillary Teeth Using Two Different Corticotomy Techniques. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05928143
- Acronym / sponsor ID
- UDDS-Ortho-12-2023
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 15 Feb 2018 (actual)
- Primary completion
- 15 Oct 2019 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 3 Jul 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.
This study aimed to evaluate the levels of pain, discomfort, and functional impairment associated with traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth.
40 patients requiring extraction of maxillary first premolars and maximum anchorage to retract the upper anterior teeth will participate in the study. They will be divided randomly into two groups: flapless corticotomy (20 patients) and traditional corticotomy (20 patients).
Detailed description
A corticotomy is the cutting of the bone that involves cortical bone only, leaving intact the medullary vessels and periosteum. It offers an advantage to adult patients in reducing orthodontic treatment time. The definition of traditional corticotomy is: elevating full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth apices and connected by a horizontal corticotomy; this process is done on both the labial and palatal aspects.
The definition of flapless corticotomy is a minimally invasive version of corticotomy, using a piezotome to inflict bone injury. This technique entails labial and palatal interproximal piezoelectric micro-incisions into the cortical bone without reflecting periodontal flaps.
Before enrolling each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will be inserted between the maxillary second premolar and first molar at approximately 8-10mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be leveled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be inserted.
The surgery will be carried out under local anesthesia. The traditional corticotomy will be handled by the same maxillofacial surgeon, and the flapless corticotomy will be handled by the same orthodontist.
For traditional corticotomy, incisions in the mesial aspect of one-second premolar to the mesial surface of the contralateral second premolar will be placed, and a full-thickness flap will be elevated 3 mm above the apical region of the tooth. piezoelectric under copious irrigation will make vertical and horizontal cuts (only cortical surface). The vertical cuts will be between the dental roots in the interdental cortical surfaces, stopping 2 mm short of the alveolar crest occlusally. The horizontal cut will connect the vertical cuts 2 mm beyond the root apex. These cuts will be performed from the mesial aspect one-second premolar to the mesial surface of the contralateral second premolar involving the anterior. Similarly, a palatal flap incision will be raised immediately for doing the same vertical and horizontal cuts in the superficial surface of the palatal bone.
For the flapless corticotomy, the depth of gingival tissue will be determined through bone sounding using a periodontal probe. A scalpel will be used to make the incisions through the gingiva, 4mm below the interdental papilla, to preserve the coronal attached gingiva. These vertical incisions will be placed from the mesial aspect of the one-second premolar to the mesial surface of the contralateral second premolar on the labial and palatal aspects of the maxilla through the gingiva and the underlying bone. A piezo-surgery knife will be used to create the cortical alveolar incisions to a depth of 1 mm within the cortical bone.
The surgical procedure will be performed, and (250-300) g force will be applied on each side (3-4 days) after corticotomy using two Nickle-Titanium (NiTi) springs attached between the mini-implants and the soldered hooks in a direction approximately parallel to the occlusal plane for conducting an en-masse retraction. The force level will be measured every 2 weeks after the corticotomy. Retraction will be stopped when a class I canine relationship is achieved, and a good incisor relationship will be obtained.
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 corticotomyIn this group, the acceleration procedure will be performed by elevating flaps and doing the surgical intervention directly using surgical burs. |
| Flapless corticotomy | Experimental | Procedure: Flapless corticotomyIn this group, the acceleration procedure will be performed without elevating flaps, and the surgical intervention will be performed using a special device. |
Who may qualify
- Ages
- 17 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Adult healthy patients
- Class II Division 1 malocclusion :
- Permanent occlusion.
- Existence of all the upper teeth (except third molars).
- Good oral and periodontal health:
Key exclusion criteria (9 listed)
- Medical problems that affect tooth movement (corticosteroid, nonsteroidal anti-inflammatory drugs (NSAIDs))
- Presence of primary teeth in the maxillary arch
- Missing permanent maxillary teeth (except third molars).
- Poor oral hygiene or Current periodontal disease:
- Previous orthodontic treatment
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 corticotomyA flap covering the alveolar process will be elevated. Perforations will be done using surgical burs, and then the flap will be returned, and sutures will be performed. | Procedure or surgery | Traditional corticotomy |
| Flapless corticotomySome incisions will be made in the mucosa of the alveolar process. Then these incisions will allow the working head of the piezotome to cut the bone in grooves. The whole procedure will not require flap elevation and replacement. | Procedure or surgery | Flapless corticotomy |
Primary outcome
Change in the levels of pain
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of pain (Item no 01): 'What is the degree of pain you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the levels of discomfort
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of discomfort: 'What is the degree of discomfort you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no discomfort- 100: the worst discomfort). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the perception of swelling
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of swelling: 'What is the degree of swelling you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no swelling- 100: the worst swelling). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the levels of chewing difficulty
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
'What is the degree of mastication difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: too much difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the levels of swallowing difficulty
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling of swallowing: 'What is the degree of swallowing difficulties you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no difficulty- 100: the worst difficulty). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Change in the levels of jaw movement restriction
Time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days
Patients will be asked this question about their feeling about the jaw movement restriction: 'What is the degree of the jaw movement restriction you have experienced?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment levels during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no restriction- 100: maximum restriction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
Level of satisfaction
Time frame: This outcome will be assessed at 28 days following the surgical intervention
Patients will be asked this question about their satisfaction level: 'What is your level of satisfaction on the orthodontic treatment provided?' A standardized questionnaire will be used to assess pain, discomfort, and functional impairment during the active phase of treatment. The patient will be asked to specify a point on the visual analog scale (VAS), a 100-mm horizontal line with two focal points at its beginning and end (0: there is no satisfaction- 100: the highest satisfaction). The score will be determined by measuring the distance from the beginning until the point identified by the patient.
The more discomfort procedure between two interventions
Time frame: This outcome will be assessed at 28 days following the surgical intervention
Patients will be asked this question: (Which surgical intervention was more discomfort ("extraction of premolars" or "the surgical procedure for acceleration"?) Assessment will be performed using a three-point scale: 1- premolar extraction, 2- surgical procedure, or 3-the same.
The willingness to undergo this procedure again
Time frame: This outcome will be assessed at 28 days following the surgical intervention
Patients would be asked this question about the possibility of repeating the surgical procedure if they had to make the decision again: 'Would you accept to undergo this treatment again?' Assessment will be performed using a two-point scale: Yes/No.
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 3 Jul 2023.
- 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 35796046Mousa MM, Hajeer MY, Burhan AS, Almahdi WH. Evaluation of patient-reported outcome measures (PROMs) during surgically-assisted acceleration of orthodontic treatment: a systematic review and meta-analysis. Eur J Orthod. 2022 Dec 1;44(6):622-635. doi: 10.1093/ejo/cjac038.
- Background: PubMed 27129491Charavet C, Lecloux G, Bruwier A, Rompen E, Maes N, Limme M, Lambert F. Localized Piezoelectric Alveolar Decortication for Orthodontic Treatment in Adults: A Randomized Controlled Trial. J Dent Res. 2016 Aug;95(9):1003-9. doi: 10.1177/0022034516645066. Epub 2016 Apr 29.
- Background: PubMed 24326120Lombardo L, Ortan YO, Gorgun O, Panza C, Scuzzo G, Siciliani G. Changes in the oral environment after placement of lingual and labial orthodontic appliances. Prog Orthod. 2013 Sep 11;14:28. doi: 10.1186/2196-1042-14-28.
- 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.
- 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 Khlef, DDS, MSc principal investigator
Department of Orthodontics, Faculty of Dentistry, Damascus University, 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 13 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: finished, as of the sponsor's last update on 3 Jul 2023. 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 (time frame: After 24 hours of the surgical intervention; 4 days; 7 days; 14 days; 28 days). The study lists 9 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 NCT05928143, 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 3 Jul 2023.