NCT07566676

Brief Summary

Study will be directed to evaluate the dentoalveolar changes following maxillary incisor intrusion using utility arch assisted with micro-osteoperforations in deep bite cases.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
38mo left

Started May 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2029

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 24, 2026

Last Update Submit

April 30, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Amount of root resorption

    Up to 6 months or correction of deep bite

  • Marginal bone level changes

    Up to 6 months or correction of deep bite

Secondary Outcomes (1)

  • Amount of intrusion of maxillary incisors

    Up to 6 months or correction of deep bite

Study Arms (2)

Maxillary incisor intrusion with utility arch assisted with micro-osteoperforations.

EXPERIMENTAL

Using Ricketts utility arch in the maxillary arch inside the molar tubes bypassing premolars and canines to engage inside the four incisors brackets with application of micro-osteoperforations above the apices of maxillary incisors.

Procedure: Micro-osteoperforations

Maxillary incisor intrusion with utility arch without micro-osteoperforations

ACTIVE COMPARATOR

Using Ricketts utility arch in the maxillary arch inside the molar tubes bypassing premolars and canines to engage inside the four incisors brackets without application of micro-osteoperforations.

Device: Utility arch

Interventions

Using utility arch with micro-osteoperforations (MOPs). The biologic mechanism behind MOPs is to increase the cytokine expression that leads to increase bone resorption and the catabolic phase of tooth movement in the direction of tooth movement. Transmucosal holes in cortical bone are made to trigger bone remodeling changes for faster tooth movement at the apices above maxillary incisors to evaluate the amount of movement and amount of root resorption.

Also known as: MOPs
Maxillary incisor intrusion with utility arch assisted with micro-osteoperforations.

Patients will receive utility arch for intrusion of maxillary incisors without micro-osteoperforations.

Maxillary incisor intrusion with utility arch without micro-osteoperforations

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients age between 15-25 years.
  • Patients with overbite ≥ 4 mm.
  • All permanent teeth erupted (excluding 3rd molars).
  • No previous orthodontic treatment.
  • Patients with good oral hygiene and good periodontal health.

You may not qualify if:

  • Skeletal discrepancies.
  • Missing maxillary anterior teeth or any kind of tooth/root shape anomaly.
  • Patients with root resorption or impacted canines.
  • Previous history of orthodontic treatment.
  • Systemic disease interferes with orthodontic tooth movement.
  • History of trauma affecting the maxillary incisors.
  • Poor oral hygiene or periodontally compromised patient.
  • Endodontically treated upper anterior teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental Medicine (Boys), Al-Azhar University

Cairo, Nasr City, 4434103, Egypt

RECRUITING

MeSH Terms

Conditions

Root Resorption

Interventions

morpholinopropane sulfonic acid

Condition Hierarchy (Ancestors)

Tooth ResorptionTooth DiseasesStomatognathic Diseases

Study Officials

  • Hussein N.I Al khalifa, Professor, Vice Dean (Phd)

    Faculty of Dental medicine (Boys), Al-Azhar University, Cairo, Egypt

    STUDY DIRECTOR
  • Raafat E. Mohamed, Prof, Head of Department (Phd)

    Faculty of Dental medicine (Boys), Al-Azhar University, Cairo, Egypt

    STUDY DIRECTOR

Central Study Contacts

Taha S.S Hossameldin, MSc Candidate

CONTACT

Hussein N.I Al khalifa, Professor, Vice Dean (Phd)

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MSc Candidate in Orthodontics

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 5, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data will not be shared due to privacy considerations.

Locations