Maxillary ExpansionNCT05740592
Micro-invasive Methods of Mid-palatal Sutural Separation
A study testing micro-osteoperforations ,microincision in people with Maxillary Expansion, run by University of Baghdad.
Trial summary
This trial aims to evaluate the effect of different micro-invasive methods (piezoelectric and micro-osteoperforation) along with tooth-tooth borne RPE compare to tooth-bone borne MARPE on the amount of mid-palatal sutural separation in late adolescent patients. Read more about this study
- Who is it for?
- Ages 14 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Expansion
- What is being tested?
- micro-osteoperforations ,microincision
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2023to 20 Aug 2023
- 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 14 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with the bilateral maxillary transverse deficiency.
- Patient referred by orthodontists for SARME or MARPE.
- Patients with developmental age in stage C or stage D maturation stages .
- Patients without developmental deformity.
- Good oral hygiene.
- Patient with intact maxillary first premolars and first molars.
Who cannot join
- Congenital maxillofacial deformities mainly cleft patients.
- Previous orthodontic and surgical treatment on the maxilla.
- Maxillary trauma.
- Previous extraction in the maxillary arch.
- Patients with periodontal disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Influence of Different Micro-Invasive Methods on Mid-Palatal Suture Separation With Rapid Maxillary Expansion in Late Adolescence: A Randomized Clinical Trial
This trial aims to evaluate the effect of different micro-invasive methods (piezoelectric and micro-osteoperforation) along with tooth-tooth borne RPE compare to tooth-bone borne MARPE on the amount of mid-palatal sutural separation in late adolescent patients. Null Hypothesis There is no effect of adjunctive micro-invasive methods (piezoelectric and microosteoperforation) on mid-palatal suture separation with tooth-tooth borne RPE appliance compared to tooth-bone borne MARPE
Read the detailed description
IMTD is commonly encountered in clinical practice and is treated using tooth-borne RME. Adult patients undergoing orthodontic treatment with tooth-borne RME frequently experience slight skeletal expansion, extrusion of posterior teeth, inability to open the palatal suture, and treatment relapse. Applying expansion forces directly to the midpalatal suture with bone-borne RME miniscrew implants is an alternative method. These bone-borne RME devices had more excellent orthopedic effects and fewer dentoalveolar side effects than their tooth-borne counterparts. Several factors, including the activation rate, influence the efficacy of RME residing in bone, such as the activation rate.
Clinical activation procedures for tooth-borne RME may not apply to bone-borne infections. As there is no existing consensus on standards for bone-borne RME, it is necessary to investigate expansion methods for these devices. In addition, the quality and amount of bone production rely on the rate of sutural growth, albeit to a lesser extent. A higher expansion rate has been related to increased sutural separation. However, the exact nature of this association and the most remarkable instantaneous expansion feasible without affecting sutural bone development have not been determined.
Using direct pressures with maximum instantaneous expansion to open mature midpalatal sutures can result in significant sutural stresses, and varied MTD is commonly observed clinically and controlled with tooth-borne RME. Adult patients undergoing orthodontic treatment with tooth-borne RME frequently experience slight skeletal expansion, extrusion of posterior teeth, inability to open the palatal suture, and treatment relapse. Applying expansion forces directly to the midpalatal suture with bone-borne RME miniscrew implants is an alternative method. These bone-borne RME appliances produced more robust orthopedic results and fewer dentoalveolar side effects than tooth-borne ones. Several parameters, including activation rate, influence the effectiveness ofbone-borne RME.
Clinical activation techniques for tooth-borne RME might not apply to bone-borne RME. As there is no current consensus on standards for bone-borne RME, expansion techniques for these devices require exploration. In addition, the rate of sutural expansion influences the quality and amount of bone production, albeit to a lesser extent. Although a faster expansion rate has been related to more significant sutural separation, the exact nature of this association and the most remarkable instantaneous expansion feasible without impairing sutural bone development have not been determined. Nonetheless, using direct forces with the maximal immediate expansion to open mature midpalatal sutures might result in substantial sutural strains and varying degrees of pain. SARME was utilized to assist transverse maxillary expansion in older individuals to alleviate high sutural tension and discomfort.
It has been discovered that the midpalatal suture offers the most resistance to maxillary expansion. For successful maxillary expansion in adult patients, it is necessary to overcome bone resistance at the midpalatal suture. Numerous techniques for simplifying, securing, and improving the predictability of surgical treatments for SARME, such as piezoelectric corticotomy, have been recently investigated. The latter dramatically minimises the traumatic side effects, surgical site bleeding, and procedure and healing time associated with conventional MARPE insertion techniques. During surgery, these instruments' precision enables the creation of precise, clean, and smooth geometries.
Consequently, several therapeutic applications of piezoelectric surgery in SARME and Le Fort I osteotomy and microosteoperforation with MARPE have been documented.
However, high-quality research, such as randomized clinical trials and prospective cohort studies with a well-defined appliance design and treatment protocol, is strongly encouraged to provide a higher level of evidence regarding the efficacy of rapid maxillary expansion in late-adolescent patients treated with minimally invasive techniques, such as MOPs and piezocision. However, no prior clinical trial has been conducted to examine the impact of different micro-invasive procedures on mid-palate sutural separation and rapid palatal extension in late adolescents.
- Conditions
- Maxillary Expansion
- Being tested
- micro-osteoperforations ,microincision
- Keywords
- microincision, microosteoperforation, MARPE, Hyrax, adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
micro-osteoperforations ,microincisionProcedure or surgery
Also called hyrax
Patients in MOPs group will be subjected to minimal 6 MOPs 2mm apart and corticoperforation will be conducted by using drilling bure and only 1 or 2mm bicortical in the mid-palatal suture area. Patients with the piezocision group will be subjected to minimal 3 micro incisions spaced 4mm apart and a piezoelectric device with diamond surgical tip (size: 4 mm, thickness: 0.5mm) will be used.. The MARPE technique comprises the insertion of four bicortical miniscrews adjacent to the mid-palatal suture, being two mesial and two distal to the expanding screw. Each MARPE have two arms and will be fixed to molar band by soldering.
| Study group | Role | What they receive |
|---|---|---|
| tooth-tooth borne RPE with MOPs | Experimental | many approaches have been established to speed up orthodontic tooth movement and to decrease adverse effects. These methods are classified as, microinvasive methods include cortectomies and distraction osteogenesis and microinvasive methods include micro-osteoperforations (MOPs) and piezocision Microtrauma to the bone showed increase the synthesis of cytokines and chemokines, which are routinely released when orthodontic forces are applied . As a result, the affected area is undergoing a faster bone regeneration process Receives: Procedure: micro-osteoperforations ,microincision |
| Tooth-Tooth borne RPE with Piezocision group | Experimental | Piezosurgery is an ultrasonic micro vibration-based bone cutting method. It used as a careful, promising, and soft tissue sparing method. In addition to its simplicity of use in the clinic, scientific evidence from animal models measuring wound healing and bone formation suggests that, piezosurgery has a better tissue response than traditional bone-cutting procedures
. Receives: Procedure: micro-osteoperforations ,microincision |
| Tooth-Bone borne RPE group (MARPE) | Active comparator | The MARPE is a RPE device with a rigid element that attached to palate by the aid of miniscrew, exerting the expansion force directly to the maxilla's basal bone Receives: Procedure: micro-osteoperforations ,microincision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoral scanner outcomes
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
Measured: T0: before expansion
Intraoral scanner outcomes
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
Measured: T1:3 months after expansion
Intraoral scanner outcomes
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
Measured: T2: 6 months after expansion
CBCT Outcomes
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement
NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
Measured: T0: before expansion
CBCT Outcomes
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement
NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
Measured: T1:3 months after expansion
CBCT Outcomes
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement
NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
Measured: T2:6 months after expansion.
Secondary outcomes (10)
Treatment duration
The time from fixation to removal (time to event) will be recorded. The expansion rate, which can be calculated as the amount of expansion divided by the total number of follow-up periods for all participants, will be reported.
Measured: T0: before expansion, T4:3 months after expansion, T5:6 months after expansion.
Treatment duration
The time from fixation to removal (time to event) will be recorded. The expansion rate, which can be calculated as the amount of expansion divided by the total number of follow-up periods for all participants, will be reported.
Measured: T0: before expansion
Treatment duration
The time from fixation to removal (time to event) will be recorded. The expansion rate, which can be calculated as the amount of expansion divided by the total number of follow-up periods for all participants, will be reported.
Measured: T1:3 months after expansion
Treatment duration
The time from fixation to removal (time to event) will be recorded. The expansion rate, which can be calculated as the amount of expansion divided by the total number of follow-up periods for all participants, will be reported.
Measured: T2: 3 months after expansion
Periodontal health
The impact of the therapy on periodontal health and supporting structures. For premolars and molars, the gingival index, probing depths, and bleeding on probing will be among the criteria, CBCT will be used to determine the extent of buccal bone resorption.
Measured: T0: before expansion
Periodontal health
The impact of the therapy on periodontal health and supporting structures. For premolars and molars, the gingival index, probing depths, and bleeding on probing will be among the criteria, CBCT will be used to determine the extent of buccal bone resorption.
Measured: T1:3 months after expansion
Periodontal health
The impact of the therapy on periodontal health and supporting structures. For premolars and molars, the gingival index, probing depths, and bleeding on probing will be among the criteria, CBCT will be used to determine the extent of buccal bone resorption.
Measured: T2:6 months after expansion.
Soft tissue impaction
Soft tissue impaction will be the third secondary outcome, which will be measured by extraoral scaner to perioral soft tissue three months following the retention period.
Measured: T0: before expansion.
Soft tissue impaction
Soft tissue impaction will be the third secondary outcome, which will be measured by extraoral scaner to perioral soft tissue three months following the retention period.
Measured: T1:3 months after expansion
Soft tissue impaction
Soft tissue impaction will be the third secondary outcome, which will be measured by extraoral scaner to perioral soft tissue three months following the retention period.
Measured: T2:6 months after expansion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start20 Mar 2023 (estimated)
- Primary completion20 Aug 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Maxillary ExpansionStudies 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
- Model description
- The first part of this study will involve a clinical trial to evaluate the efficacy of adjunctive piezoelectric sutural incision and MOPs along with maxillary expansion in terms of dentoalveolar and skeletal transverse induction in late adolescent patients.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hayder Al Naseri, University of Baghdad
- Investigators
- Harraa S. Mohammed-Salih, Ph.D., Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740592
- Sponsor's protocol ID
- 627422
- Status last verified
- Mar 2023
- First submitted
- 21 Sep 2022
- Last updated
- 7 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altug Atac AT, Karasu HA, Aytac D. Surgically assisted rapid maxillary expansion compared with orthopedic rapid maxillary expansion. Angle Orthod. 2006 May;76(3):353-9. doi: 10.1043/0003-3219(2006)076[0353:SARMEC]2.0.CO;2.
PubMed 16637711Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
PubMed 12169031
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Micro-Invasive Methods on Mid-Palatal Suture Separation With Rapid Maxillary Expansion in Late Adolescence: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05740592
- Acronym / sponsor ID
- 627422
- Conditions
- Maxillary Expansion
- Keywords
- microincision, microosteoperforation, MARPE, Hyrax, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 20 Mar 2023 (estimated)
- Primary completion
- 20 Aug 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 23 Feb 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 trial aims to evaluate the effect of different micro-invasive methods (piezoelectric and micro-osteoperforation) along with tooth-tooth borne RPE compare to tooth-bone borne MARPE on the amount of mid-palatal sutural separation in late adolescent patients. Null Hypothesis There is no effect of adjunctive micro-invasive methods (piezoelectric and microosteoperforation) on mid-palatal suture separation with tooth-tooth borne RPE appliance compared to tooth-bone borne MARPE
Detailed description
IMTD is commonly encountered in clinical practice and is treated using tooth-borne RME. Adult patients undergoing orthodontic treatment with tooth-borne RME frequently experience slight skeletal expansion, extrusion of posterior teeth, inability to open the palatal suture, and treatment relapse. Applying expansion forces directly to the midpalatal suture with bone-borne RME miniscrew implants is an alternative method. These bone-borne RME devices had more excellent orthopedic effects and fewer dentoalveolar side effects than their tooth-borne counterparts. Several factors, including the activation rate, influence the efficacy of RME residing in bone, such as the activation rate.
Clinical activation procedures for tooth-borne RME may not apply to bone-borne infections. As there is no existing consensus on standards for bone-borne RME, it is necessary to investigate expansion methods for these devices. In addition, the quality and amount of bone production rely on the rate of sutural growth, albeit to a lesser extent. A higher expansion rate has been related to increased sutural separation. However, the exact nature of this association and the most remarkable instantaneous expansion feasible without affecting sutural bone development have not been determined.
Using direct pressures with maximum instantaneous expansion to open mature midpalatal sutures can result in significant sutural stresses, and varied MTD is commonly observed clinically and controlled with tooth-borne RME. Adult patients undergoing orthodontic treatment with tooth-borne RME frequently experience slight skeletal expansion, extrusion of posterior teeth, inability to open the palatal suture, and treatment relapse. Applying expansion forces directly to the midpalatal suture with bone-borne RME miniscrew implants is an alternative method. These bone-borne RME appliances produced more robust orthopedic results and fewer dentoalveolar side effects than tooth-borne ones. Several parameters, including activation rate, influence the effectiveness ofbone-borne RME.
Clinical activation techniques for tooth-borne RME might not apply to bone-borne RME. As there is no current consensus on standards for bone-borne RME, expansion techniques for these devices require exploration. In addition, the rate of sutural expansion influences the quality and amount of bone production, albeit to a lesser extent. Although a faster expansion rate has been related to more significant sutural separation, the exact nature of this association and the most remarkable instantaneous expansion feasible without impairing sutural bone development have not been determined. Nonetheless, using direct forces with the maximal immediate expansion to open mature midpalatal sutures might result in substantial sutural strains and varying degrees of pain. SARME was utilized to assist transverse maxillary expansion in older individuals to alleviate high sutural tension and discomfort.
It has been discovered that the midpalatal suture offers the most resistance to maxillary expansion. For successful maxillary expansion in adult patients, it is necessary to overcome bone resistance at the midpalatal suture. Numerous techniques for simplifying, securing, and improving the predictability of surgical treatments for SARME, such as piezoelectric corticotomy, have been recently investigated. The latter dramatically minimises the traumatic side effects, surgical site bleeding, and procedure and healing time associated with conventional MARPE insertion techniques. During surgery, these instruments' precision enables the creation of precise, clean, and smooth geometries.
Consequently, several therapeutic applications of piezoelectric surgery in SARME and Le Fort I osteotomy and microosteoperforation with MARPE have been documented.
However, high-quality research, such as randomized clinical trials and prospective cohort studies with a well-defined appliance design and treatment protocol, is strongly encouraged to provide a higher level of evidence regarding the efficacy of rapid maxillary expansion in late-adolescent patients treated with minimally invasive techniques, such as MOPs and piezocision. However, no prior clinical trial has been conducted to examine the impact of different micro-invasive procedures on mid-palate sutural separation and rapid palatal extension in late adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- The first part of this study will involve a clinical trial to evaluate the efficacy of adjunctive piezoelectric sutural incision and MOPs along with maxillary expansion in terms of dentoalveolar and skeletal transverse induction in late adolescent patients.
| Arm | Type | Receives |
|---|---|---|
| tooth-tooth borne RPE with MOPs | Experimental | Procedure: micro-osteoperforations ,microincisionmany approaches have been established to speed up orthodontic tooth movement and to decrease adverse effects. These methods are classified as, microinvasive methods include cortectomies and distraction osteogenesis and microinvasive methods include micro-osteoperforations (MOPs) and piezocision Microtrauma to the bone showed increase the synthesis of cytokines and chemokines, which are routinely released when orthodontic forces are applied . As a result, the affected area is undergoing a faster bone regeneration process |
| Tooth-Tooth borne RPE with Piezocision group | Experimental | Procedure: micro-osteoperforations ,microincisionPiezosurgery is an ultrasonic micro vibration-based bone cutting method. It used as a careful, promising, and soft tissue sparing method. In addition to its simplicity of use in the clinic, scientific evidence from animal models measuring wound healing and bone formation suggests that, piezosurgery has a better tissue response than traditional bone-cutting procedures . |
| Tooth-Bone borne RPE group (MARPE) | Active comparator | Procedure: micro-osteoperforations ,microincisionThe MARPE is a RPE device with a rigid element that attached to palate by the aid of miniscrew, exerting the expansion force directly to the maxilla's basal bone |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Patients with the bilateral maxillary transverse deficiency.
- Patient referred by orthodontists for SARME or MARPE.
- Patients with developmental age in stage C or stage D maturation stages .
- Patients without developmental deformity.
- Good oral hygiene.
Key exclusion criteria (5 listed)
- Congenital maxillofacial deformities mainly cleft patients.
- Previous orthodontic and surgical treatment on the maxilla.
- Maxillary trauma.
- Previous extraction in the maxillary arch.
- Patients with 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 |
|---|---|---|
| micro-osteoperforations ,microincisionAlso: hyraxPatients in MOPs group will be subjected to minimal 6 MOPs 2mm apart and corticoperforation will be conducted by using drilling bure and only 1 or 2mm bicortical in the mid-palatal suture area. Patients with the piezocision group will be subjected to minimal 3 micro incisions spaced 4mm apart and a piezoelectric device with diamond surgical tip (size: 4 mm, thickness: 0.5mm) will be used.. The MARPE technique comprises the insertion of four bicortical miniscrews adjacent to the mid-palatal suture, being two mesial and two distal to the expanding screw. Each MARPE have two arms and will be fixed to molar band by soldering. | Procedure or surgery | Tooth-Bone borne RPE group (MARPE), Tooth-Tooth borne RPE with Piezocision group, tooth-tooth borne RPE with MOPs |
Primary outcome
Intraoral scanner outcomes
Time frame: T0: before expansion
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
Intraoral scanner outcomes
Time frame: T1:3 months after expansion
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
Intraoral scanner outcomes
Time frame: T2: 6 months after expansion
the use of an intraoral scanner RW1: The arch width defines as the distance in a straight line between the palatal cusp tip of the right and left first premolars. RW2: The arch width defines as the distance in a straight line between the mesiopalatal cusp tip of the right and left first molars. PV: The palatal vault height defines as the vertical distance from the occlusal plane to the median line of the palate in the position connecting the mesiodistal center of the left and right first molars. To assess the inter and intra reliability the arch width and palatal vault height of each patient will be measured three times.
CBCT Outcomes
Time frame: T0: before expansion
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
CBCT Outcomes
Time frame: T1:3 months after expansion
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
CBCT Outcomes
Time frame: T2:6 months after expansion.
In all groups, CBCT scans will be taken before expansion , immediately after completion of the consolidation period (3month), and 6 month after placement NFW4: Nasal floor width measured at the area of the first premolars, 5 mm above the most inferior part of the nasal floor. NFW6: Nasal floor width measured at the area of the first molars,5 mm above the most inferior part of the nasal floor. PBW4: Palatal bone width measured at the level of a line connecting the palatal root apex of the first premolars. PBW6: Palatal bone width measured at the level of a line connecting the palatal root apex of the first molars. IRD4 (Interdental Root Distance 4): The distance between the palatal root apex of the right and left first premolars. IRD6 (Interdental Root Distance 6): The distance between the palatal root apex of the right and left first molars. ICD4 (Interdental Cusp Distance 4): The distance between the mesiopalatal cusp tip of the right and left first premolars
10 secondary outcomes
Treatment duration
Time frame: T0: before expansion, T4:3 months after expansion, T5:6 months after expansion.
Treatment duration
Time frame: T0: before expansion
Treatment duration
Time frame: T1:3 months after expansion
Treatment duration
Time frame: T2: 3 months after expansion
Periodontal health
Time frame: T0: before expansion
Periodontal health
Time frame: T1:3 months after expansion
Periodontal health
Time frame: T2:6 months after expansion.
Soft tissue impaction
Time frame: T0: before expansion.
Soft tissue impaction
Time frame: T1:3 months after expansion
Soft tissue impaction
Time frame: T2:6 months after expansion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Background: PubMed 16637711Altug Atac AT, Karasu HA, Aytac D. Surgically assisted rapid maxillary expansion compared with orthopedic rapid maxillary expansion. Angle Orthod. 2006 May;76(3):353-9. doi: 10.1043/0003-3219(2006)076[0353:SARMEC]2.0.CO;2.
- Background: PubMed 12169031Baccetti T, Franchi L, McNamara JA Jr. An improved version of the cervical vertebral maturation (CVM) method for the assessment of mandibular growth. Angle Orthod. 2002 Aug;72(4):316-23. doi: 10.1043/0003-3219(2002)0722.0.CO;2.
- 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.
Harraa S. Mohammed-Salih, Ph.D. study director
University of Baghdad
Questions about this trial
What is this clinical trial studying?
A study testing micro-osteoperforations ,microincision in people with Maxillary Expansion, run by University of Baghdad.
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 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hayder A. Naseri, Ph.D. student (009647726146182, dr.haideraaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoral scanner outcomes (time frame: T0: before expansion). The study lists 6 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 NCT05740592, which also lists 2 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 7 Mar 2023.