CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Mini-implants +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05652244
NCT05652244N/ACompleted

Evaluation of Pain, Discomfort and Functional Impairment Associated With the Two-step Retraction Technique Anchored With Transpalatal Arches Versus the en Masse Retraction of Upper Anterior Teeth Anchored With Mini-implants: A Randomized Controlled Clinical Trial

Damascus University·interventional·Posted Dec 15, 2022·Updated Dec 15, 2022

In Brief

A clinical study evaluating Mini-implants and Transpalatal arche (TPA) for Class II Malocclusion. Completed, enrolled 38 participants across 1 site.

Detailed Summary

Thirty-eight patients requiring extraction of maxillary first premolars will participate in the study. They will be divided randomly into two groups: an en-masse retraction group and a two-step group. In each group, anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side, Mini-implants will be used as an anchor unit in the en-masse retraction group, and TPA in the two-step's retraction group. The levels of pain, discomfort, and functional impairments will be self-reported using a validated questionnaire with a 4-points Likert scale.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSyria
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2022
Enrollment StartJan 13, 2013
Primary CompletionMay 3, 2014
Study CompletionJan 24, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.5 years ago

Interventions

Mini-implantsdevice

En masse retraction of upper anterior teeth will be applied where mini-implants will be used as an anchor unit. Anterior teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.

Transpalatal arche (TPA)device

Two-step retraction of upper anterior teeth will be applied where transpalatal arches (TPAs) will be used as an anchor unit. Teeth retraction will be initiated after completion of the leveling and alignment phase via closed nickel-titanium coil springs applying 150 g of force per side.