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Acceleration of Orthodontic Tooth Movement

Plain-language guide to NCT05560919: phase 2, phase 3 randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent), 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05560919
Phase
phase 2, phase 3
Status
completed
Start
2021-09-20
Completion (planned or actual)
2022-04-30
Participants
18 (actual)
Design
randomized, double-blind, treatment
Conditions studied
Mild to Moderate Anterior Mandibular Segment Crowdind
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2, phase 3 trial, researchers set out to test DMSO (dimethyl sulfoxide, non-peptide solvent).

It had three arms (groups): Group 1 (experimental), Group 2 (experimental) and Group 3 (experimental).

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of 1,25 DHC at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale.

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. Local periodontal injection of dimethylsulfoxide at weekly interval (3 times). The gingival fluid volume will measured befor and after 1-1.5 hours after first injection. the same is done visit at the second and third visits. Pain during injection and treatment will be assessed using the FLACC scale and face scale.

Six participants were bonded with 0.022 × 0.028 inch slot brackets (Ortho Smile) using pre-adjusted edgewise appliance with 0.022 MBT prescriptions. ocal periodontal injection of serum at weekly interval (3 times). The gingival fluid volume will measured once. Pain during treatment will be assessed using the FLACC scale and face scale.

The registry classes the interventions as drug and other.

More on the Plan

The rate of orthodontic tooth movement depends on two general factors: the forces used in order to cause orthodontic tooth movement and respectively the individual (biological) response of the body to these forces.

There are many methods for accelerating orthodontic tooth movement. but, every method has its disadvantages, such as pain and root absorption.

Locally injected of vitamin d3 was proposed to accelerates tooth movement with minimal disadvantages, but there aren't enough clinical studies to prove this claim.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 15 years up to 25 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Mild to moderate crowding of mandible teeth. In accordance with LITTLE'S IRREGULARITY INDEX. No previous orthodontic treatment. Vital teeth with periodental tissue without root absorption,.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: previous history of orthodontic or orthopedic treatment; presence of craniofacial anomalies; presence of any signs and symptoms of gingival and periodontal diseases.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got DMSO (dimethyl sulfoxide, non-peptide solvent) and who got the comparison, which limits bias.

The DMSO (dimethyl sulfoxide, non-peptide solvent) group and the comparison group ran side by side rather than switching.

As a double-blind DMSO (dimethyl sulfoxide, non-peptide solvent) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2021-09-20 with completion listed for 2022-04-30.

It ran at 1 site in Syria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Primary Outcome Measure was the overall time needed to complete leveling and aligning (OLAT) the mandible dental arch (time frame: 6 months).

It also tracked 2 secondary outcomes, for example VAS scale.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of DMSO (dimethyl sulfoxide, non-peptide solvent) in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the DMSO (dimethyl sulfoxide, non-peptide solvent) compound page, all human trials.

Our Notes on the Compound

DMSO (dimethyl sulfoxide, non-peptide solvent): A solvent that carries substances through skin and into the blood, described as a free-radical scavenger; not a peptide.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.