Crowding of Anterior Mandibular TeethNCT04728464
Pain, Acceptance, and Discomfort With Periodontally Accelerated Osteogenic Orthodontics (PAOO)
An observational study of Crowding of Anterior Mandibular Teeth, run by Damascus University at 1 site in Syria.
Trial summary
Patients will be examined in the Orthodontic Department of the University of Damascus Dental School. Patients who will be treated in conjunction with the PAOO procedure and subjects who will meet the inclusion criteria will be included then the initial diagnostic records (diagnostic gypsum models, internal and… Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Crowding of Anterior Mandibular Teeth
- What is being tested?
- Periodontally Accelerated Osteogenic Orthodontics (PAOO)
- Type of treatment
- Surgery or procedure
- How many people
- 16 participants
- Where
- 1 siteSyria
- Study dates
- 29 Aug 2018to 1 Nov 2020
- Phase
- Observational
- 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 28 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with malocclusion 1. Crowding on the lower arch with a moderate degree (i.e., between 4 to six millimeters of a tooth-size-arch-length discrepancy). 2. Class I malocclusion 3. With no severe skeletal discrepancy.
Who may be able to join
- Class I malocclusion with moderate crowding (4-6 mm of a tooth-size-arch-length-discrepancy).
- Good oral hygiene and periodontal health.
- No severe skeletal discrepancy.
- Normal proclination for the upper and lower incisors.
- No congenitally missing or extracted teeth (except for the third molars).
Who cannot join
- Bimaxillary dentoalveolar severe protrusion.
- Previous orthodontic treatment.
- Subject with psychological abnormalities.
- Subject with systemic diseases.
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 of 'Periodontally Accelerated Osteogenic Orthodontics' (PAOO) in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Prospective Non-controlled Cohort Study
Patients will be examined in the Orthodontic Department of the University of Damascus Dental School. Patients who will be treated in conjunction with the PAOO procedure and subjects who will meet the inclusion criteria will be included then the initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria will be accurately matched. This study aims to assess patients' acceptance of the PAOO procedure as well as the levels of pain and discomfort associated with this treatment.
Read the detailed description
Surgical procedure associated with PAOO The surgery will be performed under local anesthesia and then full-thickness flaps will be reflected labially only from the distal surface of the lower right canine to the distal surface of the lower left canine, after washing the exposed alveolar bone with saline, then a selective cortical cutting will be performed using a piezosurgery and then the Bone-D® xenograft (particle size of 0.2 mm-1.0 mm) from Medpark (Busan, Korea) will be placed, then the wound will be sutured. Then a schedule will be set up to review the patient after 1, 7, 14, and 28 days to fill out questionnaires related to pain, acceptance, discomfort, satisfaction, and follow-up to orthodontic treatment.
- Conditions
- Crowding of Anterior Mandibular Teeth
- Being tested
- Periodontally Accelerated Osteogenic Orthodontics (PAOO)
- Keywords
- Visual Analog Scale, Acceleration, moderate crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontally Accelerated Osteogenic Orthodontics (PAOO)Procedure or surgery
Fixed appliance will be placed for every patient, then surgical procedure will be applied after reflecting a full-thickness labial flap.
| Study group | Role | What they receive |
|---|---|---|
| Periodontally Accelerated Osteogenic Orthodontics (PAOO) | Patients will be treated by Periodontally Accelerated Osteogenic Orthodontics using fixed appliances. Receives: Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perception of pain
Patients will be asked about their pain perception (item 1 of the first questionnaire).
"How much pain did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Change in perception of discomfort
Patients will be asked about their discomfort (item 2 of the first questionnaire).
"How much discomfort did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no discomfort - 100: the worst discomfort).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Change in the feeling of swelling
Patients will be asked about how much they feel swollen (item 3 of the first questionnaire).
"How much swelling did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no swelling - 100: the worst swelling).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Change in the difficulty of mastication
Patients will be asked about the difficulty of mastication (item 4 of the first questionnaire).
"How many difficulties in mastication did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty of mastication - 100: the worst difficulty of mastication).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Change in difficulty swallowing
Patients will be asked about how difficult it is to swallow (item 5 of the first questionnaire).
"How many difficulties in swallowing did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty swallowing - 100: the worst difficulty swallowing).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks]
Change in the limits of opening the mouth
Patients will be asked about the limits of the mouth opening limits (item 6 of the first questionnaire).
"How much mouth limitation did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no limitation in opening the mouth - 100: the worst limits in opening the mouth).
Measured: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Change in the level of satisfaction with accelerated treatment
Patients will be asked about satisfaction with accelerated treatment (item 1 of the second questionnaire).
"How much are you satisfied with your accelerated treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS).
The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no satisfaction with accelerated treatment - 100: best satisfaction with accelerated treatment).
Measured: (1) after 4 weeks following the beginning of the treatment
Recommendation for the procedure
Patients will be asked about a friend's recommendation for this procedure (item 2 of the second questionnaire).
"Would you recommend this procedure to a friend?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (yes, no) and the patient will select one answer yes or no.
Measured: (1) after 4 weeks following the beginning of the treatment
Taking any type of pain killers
Patients will be asked about taking any type of pain killers (item 3 of the second questionnaire).
"Did you take any type of pain killers during the treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (Yes, No) and the patient will select one answer yes or no.
If the patient's answer is (Yes), he is asked to specify the number of pain killers that he took during the treatment "when did you take pain killers? How many tablets as a whole?"
Measured: (1) after 4 weeks following the beginning of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2021
- Study start29 Aug 2018
- Primary completion1 Jul 2020
- Study completion1 Nov 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 Crowding of Anterior Mandibular TeethStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hallaj I Alsino, DDS, Principal investigator, MSc student at the Orthodontic Department, University of Damascus DentalMohammad Y Hajeer, DDS,MSc,PhD, Study chair, Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, SyriaIssam Khoury, 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
- NCT04728464
- Sponsor's protocol ID
- UDDS-Ortho-01-2021
- Status last verified
- Jan 2021
- First submitted
- 24 Jan 2021
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
PubMed 25478442Chandra RV, Rachala MR, Madhavi K, Kambalyal P, Reddy AA, Ali MH. Periodontally accelerated osteogenic orthodontics combined with recombinant human bone morphogenetic protein-2: An outcome assessment. J Indian Soc Periodontol. 2019 May-Jun;23(3):257-263. doi: 10.4103/jisp.jisp_612_18.
PubMed 31143007Shoreibah EA, Ibrahim SA, Attia MS, Diab MM. Clinical and radiographic evaluation of bone grafting in corticotomy-facilitated orthodontics in adults. J Int Acad Periodontol. 2012 Oct;14(4):105-13.
PubMed 23210199Gibreal 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 30991984Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19.
PubMed 11829041
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Levels of Pain and Discomfort of 'Periodontally Accelerated Osteogenic Orthodontics' (PAOO) in the Leveling and Alignment of Crowded Lower Anterior Teeth: A Prospective Non-controlled Cohort Study
- ClinicalTrials.gov ID
- NCT04728464
- Acronym / sponsor ID
- UDDS-Ortho-01-2021
- Conditions
- Crowding of Anterior Mandibular Teeth
- Keywords
- Visual Analog Scale, Acceleration, moderate crowding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 28 Jan 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.
Patients will be examined in the Orthodontic Department of the University of Damascus Dental School. Patients who will be treated in conjunction with the PAOO procedure and subjects who will meet the inclusion criteria will be included then the initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, as well as radiographic images) will be studied to ensure that the selection criteria will be accurately matched. This study aims to assess patients' acceptance of the PAOO procedure as well as the levels of pain and discomfort associated with this treatment.
Detailed description
Surgical procedure associated with PAOO The surgery will be performed under local anesthesia and then full-thickness flaps will be reflected labially only from the distal surface of the lower right canine to the distal surface of the lower left canine, after washing the exposed alveolar bone with saline, then a selective cortical cutting will be performed using a piezosurgery and then the Bone-D® xenograft (particle size of 0.2 mm-1.0 mm) from Medpark (Busan, Korea) will be placed, then the wound will be sutured. Then a schedule will be set up to review the patient after 1, 7, 14, and 28 days to fill out questionnaires related to pain, acceptance, discomfort, satisfaction, and follow-up to orthodontic treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Periodontally Accelerated Osteogenic Orthodontics (PAOO) | – | Procedure: Periodontally Accelerated Osteogenic Orthodontics (PAOO)Patients will be treated by Periodontally Accelerated Osteogenic Orthodontics using fixed appliances. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with malocclusion 1. Crowding on the lower arch with a moderate degree (i.e., between 4 to six millimeters of a tooth-size-arch-length discrepancy). 2. Class I malocclusion 3. With no severe skeletal discrepancy.
Key inclusion criteria (5 listed)
- Class I malocclusion with moderate crowding (4-6 mm of a tooth-size-arch-length-discrepancy).
- Good oral hygiene and periodontal health.
- No severe skeletal discrepancy.
- Normal proclination for the upper and lower incisors.
- No congenitally missing or extracted teeth (except for the third molars).
Key exclusion criteria (4 listed)
- Bimaxillary dentoalveolar severe protrusion.
- Previous orthodontic treatment.
- Subject with psychological abnormalities.
- Subject with systemic diseases.
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 |
|---|---|---|
| Periodontally Accelerated Osteogenic Orthodontics (PAOO)Fixed appliance will be placed for every patient, then surgical procedure will be applied after reflecting a full-thickness labial flap. | Procedure or surgery | Periodontally Accelerated Osteogenic Orthodontics (PAOO) |
Primary outcome
Change in perception of pain
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Patients will be asked about their pain perception (item 1 of the first questionnaire). "How much pain did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no pain - 100: the worst pain).
Change in perception of discomfort
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Patients will be asked about their discomfort (item 2 of the first questionnaire). "How much discomfort did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no discomfort - 100: the worst discomfort).
Change in the feeling of swelling
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Patients will be asked about how much they feel swollen (item 3 of the first questionnaire). "How much swelling did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no swelling - 100: the worst swelling).
Change in the difficulty of mastication
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Patients will be asked about the difficulty of mastication (item 4 of the first questionnaire). "How many difficulties in mastication did you have?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty of mastication - 100: the worst difficulty of mastication).
Change in difficulty swallowing
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks]
Patients will be asked about how difficult it is to swallow (item 5 of the first questionnaire). "How many difficulties in swallowing did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no difficulty swallowing - 100: the worst difficulty swallowing).
Change in the limits of opening the mouth
Time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks
Patients will be asked about the limits of the mouth opening limits (item 6 of the first questionnaire). "How much mouth limitation did you feel?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: there is no limitation in opening the mouth - 100: the worst limits in opening the mouth).
Change in the level of satisfaction with accelerated treatment
Time frame: (1) after 4 weeks following the beginning of the treatment
Patients will be asked about satisfaction with accelerated treatment (item 1 of the second questionnaire). "How much are you satisfied with your accelerated treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered by the Visual Analog Scale (VAS). The patient will specify a point on the line that expresses his feels, the score is determined by measuring the distance from the beginning until the point identified by the patient. The analog scale is a 100 mm horizontal line with two focal points at its beginning and end (0: no satisfaction with accelerated treatment - 100: best satisfaction with accelerated treatment).
Recommendation for the procedure
Time frame: (1) after 4 weeks following the beginning of the treatment
Patients will be asked about a friend's recommendation for this procedure (item 2 of the second questionnaire). "Would you recommend this procedure to a friend?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (yes, no) and the patient will select one answer yes or no.
Taking any type of pain killers
Time frame: (1) after 4 weeks following the beginning of the treatment
Patients will be asked about taking any type of pain killers (item 3 of the second questionnaire). "Did you take any type of pain killers during the treatment?" A standardized questionnaire to assess pain, acceptance, and discomfort during the first month of treatment based on a set of questions that will be answered. The scale is two-point (Yes, No) and the patient will select one answer yes or no. If the patient's answer is (Yes), he is asked to specify the number of pain killers that he took during the treatment "when did you take pain killers? How many tablets as a whole?"
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 2 Feb 2021.
- Background: PubMed 25478442Bhattacharya P, Bhattacharya H, Anjum A, Bhandari R, Agarwal DK, Gupta A, Ansar J. Assessment of Corticotomy Facilitated Tooth Movement and Changes in Alveolar Bone Thickness - A CT Scan Study. J Clin Diagn Res. 2014 Oct;8(10):ZC26-30. doi: 10.7860/JCDR/2014/9448.4954. Epub 2014 Oct 20.
- Background: PubMed 31143007Chandra RV, Rachala MR, Madhavi K, Kambalyal P, Reddy AA, Ali MH. Periodontally accelerated osteogenic orthodontics combined with recombinant human bone morphogenetic protein-2: An outcome assessment. J Indian Soc Periodontol. 2019 May-Jun;23(3):257-263. doi: 10.4103/jisp.jisp_612_18.
- Background: PubMed 23210199Shoreibah EA, Ibrahim SA, Attia MS, Diab MM. Clinical and radiographic evaluation of bone grafting in corticotomy-facilitated orthodontics in adults. J Int Acad Periodontol. 2012 Oct;14(4):105-13.
- 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 11829041Wilcko WM, Wilcko T, Bouquot JE, Ferguson DJ. Rapid orthodontics with alveolar reshaping: two case reports of decrowding. Int J Periodontics Restorative Dent. 2001 Feb;21(1):9-19.
- Individual participant dataSharing planned: No
Related trials for Crowding of Anterior Mandibular Teeth
Active, not recruiting
Treatment of the Mandibular Dental Crowding With and Without Corticotomy Surgery
Dental Research, Orthodontics
Not yet recruiting
Bracketless Orthodontic Treatment (3D-BOT) Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
Mild-to-Moderate Mandibular Anterior Crowding
Recruiting
Evaluating the Efficacy of Micro-Osteoperforations Technique on the Orthodontic Tooth Movement Acceleration in Moderate Mandibular Anterior Crowding Cases Treated With Clear Aligners
Crowding of Anterior Mandibular Teeth
Enrolling by invitation
Efficiency, Efficacy, Periodontal & Occlusal Outcomes for Aligners Versus Fixed Orthodontic Appliances in Crowded Incisor Treatment
Crowding of Anterior Mandibular Teeth
Active, not recruiting
Effects of Laser Therapy and Vitamin D Pills on Braces Tooth Movement: A Random Controlled Study
Malocclusion of Anterior Teeth
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.
Hallaj I Alsino, DDS principal investigator
MSc student at the Orthodontic Department, University of Damascus Dental
Mohammad Y Hajeer, DDS,MSc,PhD study chair
Associate Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria
Issam Khoury, 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?
An observational study of Crowding of Anterior Mandibular Teeth, 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 5 inclusion and 4 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 2 Feb 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 perception of pain (time frame: (1) one day following the beginning of the treatment, (2) after a week of the beginning of treatment, (3) after 2 weeks, (4) after 4 weeks). 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 NCT04728464, 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 2 Feb 2021.