Clinical trial NCT06507319: Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
Official title: Comparative Evaluation Of Two Bone-Anchored Maxillary Molar Distalization Appliances: Direct Versus Indirect Anchorage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Maxillary First Molar Distalization
Keywords: orthodontics
miniscrews
distalization
direct anchorage
indirect anchorage
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anteroposterior skeletal measurements
timeFrame: 8 months
measure: Vertical skeletal measurements
timeFrame: 8 months
measure: Dental angular measurements
timeFrame: 8 months
measure: Amount of distalization
timeFrame: 8 months
measure: Amount of intrusion
timeFrame: 8months
measure: Amount of expansion
timeFrame: 8 months
measure: Amount of rotation
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
Study officials:
References: