Faculty of Dentistry
Al Mansurah, Egypt
Location status: Recruiting
Recruiting
NCT Number: NCT06507319
Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
Aim of study: this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Material and methods: The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University.
Patients will be divided into 2 groups, group 1 will be treated by direct bone anchored pull distal slider, and group 2 by indirect bone anchored dual force distalizer.
Recruiting
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Conditions
Age range
12 year–16 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
Aim of study:
this study will be conducted for Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage.
Participant and eligibility criteria:
The study will consist of two groups, each group has 10 Patients. The patients will be selected from the outpatient clinic of the orthodontic department at Mansoura University. pretreatment records will be taken including: intraoral and extraoral photographs, study models, panoramic radiographs, and lateral cephalometric radiographs.
Intervention:
written and informed consents will be taken from the patients.
Group 1:
- Two metal bands will be chosen and fitted on the maxillary first molars.
- Rubber base impression material will be taken with bands in place.
- Two metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the maxillary first molars by glass ionomer luting cement and two miniscrews will be placed in their positions.
- The appliance will be activated by closed coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Group 2:
- Four metal bands ( two for maxillary first premolars and two for maxillary first molars ) will be chosen and fitted on the teeth.
- Rubber base impression material will be taken with bands in place.
- Four metal bands will be placed in their relative positions in the impression and then poured up with stone.
- Send it to the LAB for appliance fabrication.
- At delivery day, the appliance will be cemented on the teeth by glass ionomer luting cement and two miniscrews will be placed in their positions, and activated by compressing the NiTi open coil spring, which apply 300g force. Patients will be monitored every 3 weeks.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Dental class II.
- No or mild to moderate maxillary teeth crowding.
- Erupted or partially erupted maxillary second molars.
- No previous orthodontic therapy.
- Absence or minimum crowding in the mandibular arch.
- Good oral hygiene.
Exclusion criteria
- Dental class I, III
- severe maxillary teeth crowding.
- Extracted or badly decayed maxillary first molars.
- Previous orthodontic therapy.
- Severe crowding in the mandibular arch.
- Bad oral hygiene.
Treatment and study plan
Direct bone anchored pull distal slider
Devicedistalization from the palatal side only.
Indirect bone anchored dual force distalizer.
Devicedistalization from the palatal and buccal sides.
Primary outcomes
-
Anteroposterior skeletal measurements
Time frame: 8 months
From the lateral cephalometric, the maxillary and mandibular sagittal positions will be measured according to the SN plane, before and after distalization.
-
Vertical skeletal measurements
Time frame: 8 months
From the lateral cephalometric, mandibular plane angle according to the SN plane and Frankfort horizontal plane, will be measured before and after distalization.
-
Dental angular measurements
Time frame: 8 months
From the lateral cephalometric, the angle between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the SN plane will be measured before and after distalization to measure the amount of tipping.
-
Amount of distalization
Time frame: 8 months
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the pterygoid vertical (PTV) plane will be measured before and after distalization to calculate the amount of distalization in mm.
-
Amount of intrusion
Time frame: 8months
From the lateral cephalometric, the distance between teeth (maxillary central incisor, first premolar, second premolar, first molar) and the palatal plane (PP) will be measured before and after distalization to calculate the amount of intrusion in mm.
.
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Amount of expansion
Time frame: 8 months
From the study model, the maxillary inter-canine, inter-first premolar, inter-second premolar, inter-first molar, and inter-second molar widths will be measured before and after distalization to calculate the amount of expansion in mm.
-
Amount of rotation
Time frame: 8 months
From the study model, the angle between buccopalatal axis of teeth (maxillary first premolar, second premolar, first molar) and the midpalatal suture will be measured before and after distalization to calculate the amount of rotation.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Mansoura University
Other
Registry information
Important dates
- Study start
- 2023
- Primary completion
- 2024
- Study completion
- 2024
- First posted
- Jul 18, 2024
- Registry last updated
- Jul 18, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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