Tooth Borne Versus Temporary Anchorage Devices (TAD) Based Intrusion Systems for the Correction of Anterior Deep Overbite

May 24, 2024 updated by: Faculty of Dental Medicine for Girls

Tooth Borne Versus Temporary Anchorage Devices Based Intrusion Systems for the Correction of Anterior Deep Overbite;Oral Hygiene, Pain and Treatment Effect

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

this study determined which method was more compliant, efficacy and comfortable. It was performed to evaluate intrusion of upper incisors with applying tooth borne system as Connecticut Intrusion Arch (CIA) and temporary anchorage devices (TADs) [miniscrew] and evaluate the dental and skeletal cephalometric effects of these intrusion methods on individuals with deep bite caused by supraocclusion of upper incisors. It also evaluated oral hygiene and pain sensation in the two groups during the study period.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Class I or Class II malocclusion with minimal crowding.
  2. 70% to 100% overbite.
  3. High lip line with gingival display on smiling and super-eruption of maxillary incisors.
  4. All patients had permanent dentition with average to vertical growth pattern and curve of Spee of 4mm or less.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mninscrew
Miniscrews for incisor intrusion
2 different methods for incisor intrusion
Experimental: Intrusive arch
Continuous arch technique for incisor intrusion
2 different methods for incisor intrusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure distance of insicors intrusion
Time Frame: 2 years
measure in mm the distance of apical movement
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 8 months
By unit on Visual Analogue Scale
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2022

Primary Completion (Actual)

February 2, 2024

Study Completion (Actual)

March 27, 2024

Study Registration Dates

First Submitted

May 10, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • ORTHO-109-2H

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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