NCT07521267

Brief Summary

study will be directed to evaluate silver-hydroxyapatite nano-coated versus uncoated orthodontic miniscrews for en masse retraction of the upper anterior segment.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
41mo left

Started May 2026

Longer than P75 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 Progress4%
May 2026Nov 2029

First Submitted

Initial submission to the registry

April 3, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

April 3, 2026

Last Update Submit

April 8, 2026

Conditions

Class I MalocclusionMaxillary PrognathismOrthodontic Tooth Movement

Outcome Measures

Primary Outcomes (1)

  • Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction

    Assessment of the clinical and radiographically success rate of nanocoated versus uncoated orthodontic miniscrews after en masse retraction

    about 6 months

Secondary Outcomes (1)

  • Assessment of the rate of en masse retraction of the anterior segment of the upper arch

    6 months

Study Arms (2)

silver-hydroxyapatite nanocoated titanium miniscrews

EXPERIMENTAL

Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews. These miniscrews will be placed in the maxillary bone for en masse retraction of the upper anterior teeth.

Device: Silver nanoparticles

uncoated titanium miniscrews

ACTIVE COMPARATOR

Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as Arm 1, but without nano-coating.

Device: uncoated titanium miniscrews

Interventions

Silver nanoparticlesDEVICE

Patients will receive silver-hydroxyapatite nanocoated titanium miniscrews.These miniscrews will be placed in the maxillary bone for en masse retractonof the upper anterior teeth.

silver-hydroxyapatite nanocoated titanium miniscrews
uncoated titanium miniscrewsDEVICE

Patients will receive conventional uncoated titanium miniscrews of the same dimensions and design as the intervention of the group1, but without nano-coating.

uncoated titanium miniscrews

Eligibility Criteria

Age14 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Class I orthodontic cases with bimaxillary protrusion of the anterior segment of the upper jaw that need at least extraction for orthodontic treatment.
  • Age 14-20 years.
  • Good oral hygiene with healthy periodontium.
  • Need for an absolute skeletal anchorage.
  • Systemically healthy patients.

You may not qualify if:

  • Patient with craniofacial anomalies (e.g, cleft lip and palate)
  • Presence of systemic diseases or syndromes affecting bone metabolism (e.g, osteoporosis, rickets)
  • Poor oral hygiene or uncooperative patients.
  • Extensive dental caries or untreated periodontal disease.
  • History of trauma or surgery affecting the maxilla or mandible.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cairo, Cairo Governorate, 4434103, Egypt

RECRUITING

MeSH Terms

Conditions

Malocclusion, Angle Class I

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Study Officials

  • Mahmoud FA Aboelmahasen, Phd

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

    STUDY DIRECTOR

  • Ahmed Ak El-Awady, Phd

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

    STUDY DIRECTOR

Central Study Contacts

Hashem Kh Al-Washali, MScCandidate

CONTACT

+01120042296Hashemalwashali.2.209@azhar.edu.eg

Mahmoud FA Aboelmahasen, Phd

CONTACT

+01222993318MahmoudFathy.209@azhar.edu.eg

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
Principle Investigator, MSc Candidate in Orthodontics

Study Record Dates

First Submitted

April 3, 2026

First Posted

April 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

November 1, 2029

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Data Will not be Shared Due to Privacy Consideration.

Locations

EG(1)