Effect of Maxillary Third Molar Extraction vs Non-extraction on Distalization of First Molars in a Group of Adolescent Patients Using Infra-Zygomatic Gear Distalizer: A Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Future University in Egypt
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- distalization amount of maxillary firs molars at the crown and root levels
Study Overview
Brief Summary
There is a scarcity in literature regarding the influence of maxillary third molar on distalization . This study aimed to compare the influence of unerupted maxillary third molars and their extraction on the bilateral distalization of upper first molars using the infra-zygomatic gear distalizer
Detailed Description
Maxillary molar distalization is one of the non-extraction modalities for treating class II malocclusion. When distalizing maxillary molars In adults, it is not a problem to extract fully erupted third molars, and it may even be suggested that the extraction site may accommodate distalization. On the contrary, adolescents usually have unerupted third molars with partially formed roots, rendering the surgical extraction more difficult and traumatic. The necessity of surgically extracting upper third molar buds before distalization remains questionable. Therefore, this study was conducted to three-dimensionally assess the impact of maxillary third molar presence on distalizing maxillary molars in adolescent patients having Class II malocclusion.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Only the outcome assessors will be blind. The patients name will be sealed from the pre- and post-radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study
Eligibility Criteria
- Ages
- 16 Years to 19 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adolescent patients aged 16-19 years
- •skeletal Class I
- •bilateral Class II molar relationship. defined by at least an end-to-end molar relationship.
- •normal vertical growth pattern.
- •full permanent dentition with unerupted upper third molars.
Exclusion Criteria
- •skeletal Class II or Class III relationship.
- •past orthodontic treatment.
- •poor oral hygiene.
- •Increased vertical dimension.
Arms & Interventions
Third molar extraction group
After surgical extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.
Intervention: Distalization combined with upper third molars extraction (Procedure)
Third molar presence group
Without extraction of unerupted upper third molars, the maxillary first molars were distalized using the infra-zygomatic gear distalizer, which is anchored to infra-zygomatic mini-implants inserted in the infra-zygomatic crest.
Intervention: Distalization without upper third molars extraction (Procedure)
Outcomes
Primary Outcomes
distalization amount of maxillary firs molars at the crown and root levels
Time Frame: From pre to post distalization (an average of 8 months)
Anteroposterior changes in the position of maxillary first molars assessed on digitized models and cone beam computed tomography (CBCT) taken for each patient before and after distalization. Measurements were done by identifying landmarks, reference lines, and planes(measured in mm)
Secondary Outcomes
- Tipping of maxillary third molar(From pre- to post-distalization (an average of 8 months))
- Tipping of maxillary first molar(From pre- to post-distalization (an average of 8 months))
- Vertical position of maxillary first molar(From pre- to post-distalization (an average of 8 months))
- Molar rotation(From pre- to post-distalization (an average of 8 months))
- Vertical position of maxillary third molar(From pre- to post-distalization (an average of 8 months))
- Vertical position of upper incisors(From pre- to post-distalization (an average of 8 months))
- Inter molar width(From pre- to post-distalization (an average of 8 months))
- Anteroposterior position of upper incisors(From pre- to post-distalization (an average of 8 months))
- Rate of maxillary first molar Distalization(From pre- to post-distalization (an average of 8 months))
- Tipping of maxillary second molar(From pre- to post-distalization (an average of 8 months))
- upper incisors torque(From pre- to post-distalization (an average of 8 months))
- Anteroposterior changes of upper first and second premolars(From pre- to post-distalization (an average of 8 months))
Investigators
Nadeen Hafez
Principal investigator
Future University in Egypt