Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket

Evaluation of Apical Root Resorption in Dental Deep Bite Correction by Twin Slot Orthodontic Bracket; a Clinical Trial Study

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

Study Overview

• Status: Completed
• Conditions: Volumetric Root Resorption
• Intervention / Treatment: Procedure: Orthodontic treatment using double slot bracket wire in high level slot; Procedure: Orthodontic treatment using double slot bracket with wire in low level slot

Detailed Description

Group (A): Patients will be treated with double slot brackets using low level slot in deep bite correction. Group (B): Patients will be treated with double slot brackets using high level slot in deep bite correction.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Bohira, Egypt, 002
    • Alaa Salama

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 1. 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Evaluate the possible apical root resorption by double slot bracket withwire in high level slot.; 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; 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 .
Experimental: Evaluate the possible apical root resorption by double slot bracket with wire in low level slot.; 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; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Outcome Measure	Evaluation of alveolar bone changes using CBCT.	"through study completion, an average of 1 year".

Collaborators and Investigators

• Sponsor: Faculty of Dental Medicine for Girls
• Investigators: Principal Investigator: Samir Abdo Ibrahim, professor, AL Azher university

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2022
• Primary Completion (Actual): September 5, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: November 18, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: intrusion,root resorption
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion, Angle Class II; Malocclusion; Tooth Resorption; Overbite; Root Resorption
• Other Study ID Numbers: P-OR-22-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No