- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06430710
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
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:
- Class I or Class II malocclusion with minimal crowding.
- 70% 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.
Exclusion Criteria:
- 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.
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
Keywords
Additional Relevant MeSH Terms
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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