CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
Topical anesthesia (buccal and palatal) +6 moredrug
Likely dose
Local anesthesia (buccal and palatal) 1,5 mlfrom 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/NCT02644811
NCT02644811N/ACompleted

Miniscrews as Anchorage Device for Orthodontic Treatment - Randomized Controlled Trials on Anchorage Capacity, Cost Efficiency and Patient Acceptance

Region Gävleborg·interventional·Posted Jan 1, 2016·Updated Feb 27, 2019

In Brief

A clinical study evaluating Topical anesthesia (buccal and palatal), Local anesthesia (buccal and palatal), and 5 other interventions for Orthodontic Anchorage Procedures and Orthodontic Space Closure. Completed, enrolled 80 participants across 1 site.

Detailed Summary

The purpose of this trial is to study and compare two different anchorage techniques. Adolescent patients in need for orthodontic treatment are randomized into Group A and B. Both groups are treated with extractions of the maxillary first premolars and fixed appliance. Anchorage is reinforced by miniscrews in Group A and by molarblock in Group B. The hypotheses are: * that placement of miniscrews does not cause more pain or discomfort than premolar extractions * that molarblock provides increase of anchorage * that miniscrews have a better anchorage capacity than molarblock * that miniscrews are more cost-efficient than conventional anchorage techniques

Study Details

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 1, 2016
Enrollment StartNov 1, 2009
Primary CompletionJul 1, 2018
Study CompletionSep 21, 2018
TodayJul 2, 2026
Enrollment to primary: 8.7 yearsPosted 10.5 years ago

Interventions

Topical anesthesia (buccal and palatal)drug

Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.

Local anesthesia (buccal and palatal)drug

Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).

Extraction of the maxillary first premolarsprocedure

Careful extraction of the maxillary first premolars after mobilization.

Topical anesthesia (buccal)drug

Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.

Local anesthesia (buccal)drug

Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).

Molarblockdevice

Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.

Spider Screw K1 short neckdevice

The Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used.