NCT06704165

Brief Summary

Evaluate the possible apical root resorption during deep bite correction by double slot bracket with low level slot versus high level slot using CBCT.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2024

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

November 1, 2024

Enrollment Period

2.2 years

First QC Date

November 18, 2024

Last Update Submit

November 22, 2024

Conditions

Keywords

intrusion,root resorption

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    Evaluate and compare the amount of volumetric root resorption. CBCT used in volumetric image.

    "through study completion, an average of 1 year".

Secondary Outcomes (1)

  • Secondary Outcome Measure

    "through study completion, an average of 1 year".

Study Arms (2)

Evaluate the possible apical root resorption by double slot bracket withwire in high level slot.

EXPERIMENTAL

Control group : patients will receive a conventional therapy with Double slot bracket with the wire in high level for the treatment of anterior deep bite .

Procedure: Orthodontic treatment using double slot bracket wire in high level slot

Evaluate the possible apical root resorption by double slot bracket with wire in low level slot.

EXPERIMENTAL

investigational group will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite .

Procedure: Orthodontic treatment using double slot bracket with wire in low level slot

Interventions

patients will receives the new treatment therapy by using Double slot bracket with the wire in low level for the treatment of anterior deep bite .

Evaluate the possible apical root resorption by double slot bracket withwire in high level slot.

patients will receives the new treatment therapy by using Double slot bracket with the wire in high level for the treatment of anterior deep bite .

Evaluate the possible apical root resorption by double slot bracket with wire in low level slot.

Eligibility Criteria

Age18 Years - 23 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female patients to avoid any sexual dimorphism which may affect the comparison.
  • Age range from 18 to 23year.
  • Patients with anterior dento alveolar deep bite.
  • Angle class I or class II malocclusion with minimal crowding.
  • Healthy compliant and motivated patient.
  • No missing of any tooth except wisdom teeth

You may not qualify if:

  • \. Previous orthodontic treatments. 2. Any systemic or bone diseases. 3. Pregnant and lactating patient. 4. Prosthetic replacement in lower anterior teeth. 5. periodontitis with pocket depth more than 5 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaa Salama

Bohira, Egypt, 002, Egypt

Location

MeSH Terms

Interventions

Bone Wires

Intervention Hierarchy (Ancestors)

Internal FixatorsProstheses and ImplantsEquipment and SuppliesOrthopedic Fixation DevicesOrthopedic EquipmentSurgical EquipmentSurgical Fixation Devices

Study Officials

  • Samir Abdo Ibrahim, professor

    AL Azher university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket; A Clinical Trial Study

Study Record Dates

First Submitted

November 18, 2024

First Posted

November 26, 2024

Study Start

June 15, 2022

Primary Completion

September 5, 2024

Study Completion

October 1, 2024

Last Updated

November 26, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations