Clinical trial NCT05740592: Micro-invasive Methods of Mid-palatal Sutural Separation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Maxillary Expansion
Keywords: microincision
microosteoperforation
MARPE
Hyrax
adolescents
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 27
Sex: ALL
Minimum age (years): 14
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with the bilateral maxillary transverse deficiency.
2. Patient referred by orthodontists for SARME or MARPE.
3. Patients with developmental age in stage C or stage D maturation stages .
4. Patients without developmental deformity.
5. Good oral hygiene.
6. Patient with intact maxillary first premolars and first molars.

Exclusion Criteria:

1. Congenital maxillofacial deformities mainly cleft patients.
2. Previous orthodontic and surgical treatment on the maxilla.
3. Maxillary trauma.
4. Previous extraction in the maxillary arch.
5. Patients with periodontal disease.

Primary outcomes:
measure: Intraoral scanner outcomes
timeFrame: T0: before expansion
measure: Intraoral scanner outcomes
timeFrame: T1:3 months after expansion
measure: Intraoral scanner outcomes
timeFrame: T2: 6 months after expansion
measure: CBCT Outcomes
timeFrame: T0: before expansion
measure: CBCT Outcomes
timeFrame: T1:3 months after expansion
measure: CBCT Outcomes
timeFrame: T2:6 months after expansion.
Secondary outcomes:
measure: Treatment duration
timeFrame: T0: before expansion, T4:3 months after expansion, T5:6 months after expansion.
measure: Treatment duration
timeFrame: T0: before expansion
measure: Treatment duration
timeFrame: T1:3 months after expansion
measure: Treatment duration
timeFrame: T2: 3 months after expansion
measure: Periodontal health
timeFrame: T0: before expansion
measure: Periodontal health
timeFrame: T1:3 months after expansion
measure: Periodontal health
timeFrame: T2:6 months after expansion.
measure: Soft tissue impaction
timeFrame: T0: before expansion.
measure: Soft tissue impaction
timeFrame: T1:3 months after expansion
measure: Soft tissue impaction
timeFrame: T2:6 months after expansion.
Other outcomes:
Locations:
Study officials:
affiliation: University of Baghdad
name: Harraa S. Mohammed-Salih, Ph.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Baccetti 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.