Efficiency of Microosteoperforation for Accelerating Posterior Segment Intrusion in Skeletal Open Bite Cases

NCT07761065 | Completed FDA Device

• 1 other identifier: Posterior segment intrusion
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aimed to assess the efficiency of micro-osteoperforation for accelerating posterior intrusion in open bite cases. A human sample of thirty subjects was divided into two groups ; Group I (MOP), posterior intrusion with micro-osteoperforation (MOP) and group II (Control), same intrusion protocol without micro-osteoperforation.

Conditions

Anterior Open Bite Malocclusion

Keywords

Anterior open bite; Micro-osteoperforations; Miniscrew implants

Outcome Measures

Primary Outcomes (10)

• Rate of maxillary posterior segment intrusion (mm/4 weeks)

  Measured on serial study models obtained every 4 weeks from baseline to achievement of 1-2 mm positive overbite. The rate of maxillary posterior segment intrusion was observed from follow up digital models through superimposition of successive models by Gom software and measuring the amount of intrusion for each tooth and every follow up visit to determine the rate of intrusion of each tooth per interval. A comparison was performed between the groups to determine the effect of MOPs on the rate of intrusion.

  Study models were obtained every four weeks from baseline until a positive overbite was obtained at an average of 6-9 months .

• Skeletal, dentoalveolar and soft tissue changes

  The evaluation of skeletal, dental and soft tissue changes before and after posterior segment intrusion in each group was performed by a customized three- dimensional analysis on Anatomage software. A comparison was performed between both groups to determine any changes in the pattern of intrusion.

  Patients were subjected to posterior segment intrusion forces until a positive overbite (+1-2 mm) was obtained at an average of 6-9 months

• Evaluation of TMJ changes

  Evaluation of positional and dimensional changes of the mandibular condyle was performed by certain measurement obtained at certain cross-sectional cuts on CBCTs obtained before and after posterior segment intrusion in both groups .

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Total amount of posterior intrusion (mm)

  Three-dimensional linear change in vertical position of the maxillary posterior segment from baseline to end of intrusion, measured on CBCT using the palatal plane (ANS-PNS) as a stable reference plane. The distance from centroid of each tooth to that Palatal plane was measured before and after intrusion.

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Air way changes in volume after intrusion

  Evaluate the pharyngeal airway space (PAS) volume in cm3 for patients with anterior open bite (AOB) before and after intrusion by using cone beam computed tomography (CBCT).

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Changes in alveolar bone density after posterior intrusion

  Evaluation of alveolar bone density in Hounsfield Units (HU)ollowing intrusion using cross sectional cuts in pre- and post- intrusion CBCTs.

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Apical root resorption after intrusion (mm)

  Evaluation of the development of apical root resorption in any root of the whole posterior segment bilaterally by measuring the difference in length of all roots before and after posterior segment intrusion using CBCTs scans. A comparison was made between both groups the evaluate the difference and the efficiency of micro-osteoperforation to reduce the risk of this problem. .

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Evaluation of the relationship between the amount of posterior intrusion and the subsequent crown lengthening requirements resulting from alveolar or soft tissue excess.

  Correlation between the extent of posterior segment intrusion and the requirement for crown lengthening via alveolar bone or soft tissue reduction using CBCT obtained before and after intrusion.

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Air way changes in cross-sectional area after intrusion

  Evaluate the pharyngeal airway space (PAS) narrowest cross-sectional areas in cm2 for patients with anterior open bite (AOB) before and after intrusion by using cone beam computed tomography (CBCT).

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

• Alveolar bone trabecular architecture changes

  Evaluation of alveolar bone trabecular microstructural changes including buccal, palatal and apical alveolar bone in mm following intrusion using cross sectional cuts in pre- and post- intrusion CBCTs.

  From beginning of intrusion till a positive overbite was observed at an average of 6-9 months

Secondary Outcomes (13)

• Stability of posterior intrusion

  Post-intrusion till finishing conventional orthodontic treatment an average of 2 years post intrusion

• Root resorption after conventional orthodontic treatment

  Post-intrusion till finishing conventional orthodontic treatment an average of 2 years post intrusion

• Investigating the association between skeletal open bite malocclusion and maxillary constriction

  Three years during patients recruitment for the study

• Association between open bite and other malocclusions in anteroposterior planes

  During patients' recruitment for three years during the study

• Correlation between open bite and enamel hypoplasia

  During patients' recruitment for the study at an average of three years

Study Arms (2)

Micro-osteoperforation (MOP) Group I

EXPERIMENTAL

Micro-osteoperforation was performed immediately before applying intrusion force on the maxillary posterior segment bilaterally using maxillary intrusion splint and miniscrew implants for anchorage

Procedure: Micro-osteoperforation

Control Group II

ACTIVE COMPARATOR

Posterior segment intrusion was performed bilaterally using the same intrusion splint and miniscrew implant anchorage set-up but without micro-osteoperforations

Device: Conventional posterior segment intrusion

Interventions

Micro-osteoperforation PROCEDURE

Patients were subjected to micro-osteoperforations using Prope Excellerator MOP device. Three perforations were performed in a linear pattern at the buccal side, mesial and distal to the roots of maxillary posterior segment bilaterally immediately before intrusive force application.

Micro-osteoperforation (MOP) Group I

Conventional posterior segment intrusion DEVICE

Patients were treated with posterior segment intrusion using posterior acrylic splint. Miniscrew implants were placed bilaterally at the zygomatic buttress and palatal to maxillary first molar. Intrusion force was applied using closed coil springs from hooks at the splints to the heads of the implants for anchorage.

Control Group II

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical anterior open bite involving the incisors and canines ranging from -3 mm to -8 mm
• Skeletal open bite confirmed by pretreatment cephalometric angular and linear measurements.
• Maxillary posterior vertical dentoalveolar excess guided by the analysis of Burstone et al.
• Normal incisor display at rest and during smile.
• Non-growing postpubertal adolescent and adult patients with CVM 6 according to Baccetti et al.
• Full set of permanent dentition regardless of third molars.
• Good oral hygiene.

You may not qualify if:

• Skeletal Class III cases.
• Patients suffering from any systemic diseases or congenital anomalies affecting bone.
• Patients with previous orthodontic treatment.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbasia, 11566, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: August 12, 2026
• Study Start: April 22, 2015
• Primary Completion: December 11, 2022
• Study Completion: September 5, 2025
• Last Updated: August 12, 2026

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: No limit

Locations

EG (1)