An occasionally irregular blog about orthodontics

Do “orthodontic” pacifiers work? Someone has done a trial!

By on October 3, 2016 in Clinical Research, Recent posts with 1 Comment
Do “orthodontic” pacifiers work?  Someone has done a trial!

Do “orthodontic” pacifiers work:  Someone has done a trial!

When my children were babies we gave them pacifiers (or dummies) when we were trying to get them to sleep at night!  We weaned them off them after about a year and so we did no harm. Since then many concerned mothers have asked me  whether I thought that “orthodontic” pacifiers caused less harm that conventional pacifiers. I always told them that I did not know.  But now we have a trial that may answer this question…

jena

A team from Jena, Germany did this study and they published it in the excellent Orthodontics and Craniofacial Research

Effect of a thin-neck pacifier on primary dentition: a randomized controlled trial

Y Wagner and R Heinrich-Weltzien

Orthod Craniofac Res 2016; 19: 127–136.

DOI: 10.1111/ocr.12126

Pacifier or Non-nutritive sucking is common amongst young children and varies from 60 to 80%. In an ideal world children should stop non nutritive sucking by 24 to 36 months of age, so that they can reduce the risk of developing a malocclusion.

Parents may give several types of pacifier to their children. One of these is called an orthodontic pacifier and they have a neck that is thinner than the conventional models. This is also called a Thin Neck Pacifier (TNP).

The purpose of this study was to evaluate the effects of the TNP and conventional pacifiers on the dentition.

What did they do?

They carried out a prospective parallel group RCT.  The enrolled 86 children into the study from a larger group of patients who were attending their clinic. The inclusion criteria were:

  • Ages 16-24 months
  • Diagnosed with pacifier associated Anterior Open Bite or increased overjet
  • They were still using their pacifier.

They randomly assigned the children to one of three groups.

  1. Thin neck pacifier (n=28)
  2. Control, they continued to use their conventional pacifier (n=30)
  3. To be weaned off the pacifier during the study period (n=28)

Allocation concealment, randomisation was good. They carried out a sample size calculation..

I thought that it was important to point out that if any children (Group 3) were not successfully weaned off the pacifier they were excluded from the data analysis.

Two dentists measured the overjet, overbite and open bite.  I spotted that only one of these was blinded to the treatment allocation.  They collected the data at the start of the study and then after 3, 6, 9 and 12 months.

What did they find?

When they followed the children they lost 12 participants because they moved away. They then excluded a further 11 because of dental trauma, mouth breathing(5) and no weaning off (6).

There were no differences between the groups at the start of the study. They grouped the data and presented it at different time periods and.   This was very confusing.  I thought that the simplest and most relevant data was the dental measurements at the end of the study period. I have put this information into this table.

 Thin neck pacifierConventional pacifierWeaned offp
Overbite (mm)0.2 (1.2)-0.8 (1.8)0.5 (0.3)0.002
Overjet (mm)2.7 (0.5)3.2 (0.7)2.4 (0.7)0.031

The data analysis showed that there were statistically significant differences between those who used pacifiers and those who were weaned off for final overjet and overbite. There were no differences between the pacifiers. They carried out many multiple comparisons across the data that evaluated the change in measurements, proportion of patients in groups and whether they stopped pacifier wear. They found some differences. However, I was cautious in accepting this information because they ran multiple tests. If you test a set of data many times you are bound to find a statistically significant difference somewhere…..

They concluded that changing to a TNP reduced pacifier induced malocclusion in the primary dentition.  They said that this was a remarkable finding.

What did I think?

At first, I thought that this was a good study.  However, when I looked at it closely I found the following main problems.

Firstly, they did not use an intention to treat design. They excluded data from patients who did not stop using their pacifier.  As a result, they only included patients whose treatment (weaning off) was successful. If we consider that the intervention was a request and instruction to stop using the pacifier, then excluding the patients for not stopping did not test the intervention.

Secondly, they carried out multiple comparison tests and this increases the chance of finding a statistically significant difference that is not really there.  When I looked at the simple differences in dental measurements at the end of the study, these showed that there were no difference between the pacifiers.

Finally, they detected effect sizes that were not clinically significant. For example, there was a reduction in overjet of only 0.3mm from weaning off the pacifiers.

Most importantly, they confined this study to the primary dentition. I think that I really need information on the effects of different types of pacifiers on the permanent dentition before I can make any recommendations on their use.

Unfortunately,  these issues are rather important and I am afraid that still do not know if orthodontic pacifiers cause less harm than conventional pacifiers.

(Visited 3,102 times, 1 visits today)

Tags: , , , , , , ,

There is 1 Comment

Trackback URL | Comments RSS Feed

  1. Badar Monir Zaki says:

    Hi Kevin
    I live in the middle East and this neck of the Woods vertical problems are very common. Read AOBs. I would like it very much if you could expend some energy looking at the hearsys and the falsehood surrounding the treatment of such conditions.

Post a Comment

Your email address will not be published. Required fields are marked *

Top