Evaluation of Maxillary Posterior Teeth Intrusion by Skeletally Anchored Mousetrap Appliance in Adult Patient With Anterior Open Bite.

Evaluation of Maxillary Posterior Teeth Intrusion by Skeletally Anchored Mousetrap Appliance in Adult Patient With Anterior Open Bite

Aim of the study: This clinical study aims to evaluate the dental, skeletal, and soft tissue effects of the Mousetrap appliance on the intrusion of maxillary posterior teeth in adult patients with anterior open bite.

Material and methods: An uncontrolled clinical trial will be conducted involving 20 participants aged 15 to 27 years with skeletal Class I, II, or mild Class III relationships and a measured AOB of 3-8 mm. Participants will receive mini-implants inserted in the anterior palate, with the Mousetrap appliance designed to promote molar intrusion while maintaining vertical dimension. Intraoral scans, radiographs, and clinical photographs will be recorded at baseline and post-intrusion.

Study Overview

• Status: Recruiting
• Conditions: Maxillary Molar Intrusion
• Intervention / Treatment: Device: Mousetrap appliance

Detailed Description

Aim of the study:

This clinical study will evaluate the dental, skeletal and soft tissue effects of skeletally anchored mousetrap appliance on the intrusion of maxillary posterior teeth in adult patient with anterior open bite.

Materials and methods:

Trial Design: This study will be uncontrolled clinical trial. Intervention All patients will start the treatment by mini-implants insertion in anterior palate. Application of topical and/or local anesthesia, mini-implants will be inserted in anterior palate, using a manual contra-angle driver. The implants are oriented perpendicularly to the palatal curvature. Intraoral scanning for maxillary arch will be recorded before and after intrusion for each patient; at T0 (before intrusion), T1 (after intrusion) appliance construction: the principle of the Mousetrap appliance. For molar intrusion, lever arms are connected to two mini-implants inserted in the anterior palate. A transpalatal arch is placed to avoid tipping of the molars during intrusion. Customized intrusion appliance including upper first molar with band and occlusal rest on posterior teeth. The appliance will be digitally designed. A modified transpalatal arch with a is fitted with sufficient clearance between the palatal mucosa to avoid impingement and irritation during and after successful molar intrusion.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: waleed Mostafa Al Shannaq, orthodontist; Phone Number: +20 01507373075; Email: shunnaqwaleed@gmail.com

Study Locations

• Egypt
  • Mansoura, Egypt, 7650001
    • Recruiting
    • Faculty of Dentistry, Mansoura University
    • Contact: Ahmed Kamel Elmorsy, Phd, lecture,orthodontist; Email: ahmedkamel@mans.edu.eg
    • Contact: Marwa Ali Tawfik, prof,Phd,orthodontist; Email: marwaali@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age ranging from 15 to 27 years.
• High angle patients with skeletal Class I, II or mild Class III.
• Patients with anterior open bite requiring maxillary posterior teeth intrusion as part of orthodontic treatment.
• Anterior open bite: range from 3-8 mm.
• Healthy adult patients.
• No previous orthodontic treatment.
• No evidence of either periodontal problems, gingival problems, or bruxism, at the beginning of orthodontic treatment.
• No medical problems interfering with orthodontic treatment.

Exclusion Criteria:

• Moderate to severe Class III skeletal relationship patients were excluded, as the molars intrusion would lead to increase the severity of Class III malocclusion.
• Patient with bad oral hygiene.
• Periodontal problems.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: maxillary molar intrusion	Device: Mousetrap appliance; two mini-implant will be inserted in the palate. then, the mousetrap appliance will be inserted on the mini-implant and activated with power chain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of molar intrusion	The amount of molar intrusion performed, difference in the linear distance from the mesio-buccal cusp of maxillary first permanent molar to the palatal plane, between the pretreatment and post-intrusion cone-beam computed tomography records, will be measured	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
external root resorption	To calculate the amount of external apical root resorption, each cusp tip and root apex will be precisely detected in all three planes (sagittal, coronal and axial), for all teeth included in the study.	6 months

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2024
• Primary Completion (Estimated): September 25, 2025
• Study Completion (Estimated): September 30, 2025

Study Registration Dates

• First Submitted: December 27, 2024
• First Submitted That Met QC Criteria: December 27, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: MansouraU

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No