NCT06430710

Brief Summary

Compare the tooth borne versus fixed orthodontic intrusive system (TADs) for the correction of anterior deep overbite

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 Sep 2022

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

September 25, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 28, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1.4 years

First QC Date

May 10, 2024

Last Update Submit

May 24, 2024

Conditions

Deep Overbite

Keywords

Anterior deep biteIntrusive archMiniscrews

Outcome Measures

Primary Outcomes (1)

  • Measure distance of insicors intrusion

    measure in mm the distance of apical movement

    2 years

Secondary Outcomes (1)

  • Pain intensity

    8 months

Study Arms (2)

Mninscrew

EXPERIMENTAL

Miniscrews for incisor intrusion

Device: Intrusion

Intrusive arch

EXPERIMENTAL

Continuous arch technique for incisor intrusion

Device: Intrusion

Interventions

IntrusionDEVICE

2 different methods for incisor intrusion

Intrusive archMninscrew

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Class I or Class II malocclusion with minimal crowding.
  • % to 100% overbite.
  • High lip line with gingival display on smiling and super-eruption of maxillary incisors.
  • All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.

You may not qualify if:

  • Having missing teeth on the anterior maxillary area.
  • Any history of trauma or root canal treatment.
  • Previous orthodontic treatment.
  • Low lip line duing social smile.
  • Having any hormonal disorder or syndromes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Overbite

Interventions

Tooth Movement Techniques

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class IIMalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistry

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Sixteen patients with anterior deep over bite participated in two groups each group contains eight patients
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2024

First Posted

May 28, 2024

Study Start

September 25, 2022

Primary Completion

February 2, 2024

Study Completion

March 27, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

EG(1)