Trial reportEuropean journal of orthodontics2023
Pain and discomfort during the first week of maxillary expansion using two different expanders: patient-reported outcomes in a randomized controlled trial.
Trial report in European journal of orthodontics, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04458506 (Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.
- Research Hotspots and Emerging Trends of Orthodontic-Related Discomfort and Pain: A Bibliometric Review.Pain research & management · 2025Pooled it
- Skeletal effects of posterior crossbite treatment with either quad helix or rapid maxillary expansion: a randomized controlled trial with 1-year follow-up.The Angle orthodontist · 2024Trial
- Posterior crossbite corrections in the early mixed dentition with quad helix or rapid maxillary expander: a cost-effectiveness analysis of a randomized controlled trial.European journal of orthodontics · 2024Trial
- Auditory-Perceptual and Acoustic Characteristics of Sibilant and Vowel Sounds in Children with Cleft Palate Undergoing Rapid Palatal Expansion.Folia phoniatrica et logopaedica : official organ of the International Association of Logopedics and Phoniatrics (IALP) · 2026Article
- A novel electronic key-controlled expander for precise asymmetric palatal expansion.Frontiers in dental medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundQuad Helix (QH) is the appliance most preferred by orthodontists to correct unilateral posterior crossbite in the early mixed dentition while other orthodontists suggest rapid maxillary expansion (RME) on deciduous teeth in these patients.
objectivesTo evaluate and compare perceived pain intensity, discomfort, functional jaw impairment, and analgesic consumption during the first week of treatment with either RME or QH appliances. TRIAL
designTwo-arm parallel group, two-centre, randomized controlled trial. MATERIAL AND
methodsSeventy-two patients, mean age 9.5 (SD ±0.8) years, with unilateral posterior crossbite requiring maxillary expansion were randomly allocated to either the RME (22 boys, 14 girls) or QH (22 boys, 14 girls) group. Validated questionnaires were used to assess pain intensity, discomfort, jaw function impairment, and analgesic consumption, on the first, fourth, and seventh days after appliance insertion and activation. BLINDING: Due to clinical limitations, only the outcome assessors were blinded to the groups to which the patients were allocated.
resultsSeventy patients completed the questionnaires. Pain from the tongue and chafe from the appliance were significantly higher in the QH group on the first day of treatment (P = 0.003 and P = 0.000, respectively). On the fourth day, the chafe from the appliance was still significantly higher in the QH group (P = 0.007). Speech was affected in both groups on day 1; this impairment continued and was significantly higher in the RME group days 4 and 7. No significant difference in analgesic consumption was found between the groups at any time. The analgesic consumption was highest at day 1 of treatment. HARMS: No harm was observed in any patient. LIMITATIONS: Double blinding was not possible due to the clinical limitations.
conclusionDuring the initial 4 days of treatment, pain from the tongue and chafe from the appliance caused the most reported inconvenience in the patients in the QH group. A majority of reported visual analogue scale values were in the lower mid-range, suggesting low to moderate pain and discomfort in both groups. CLINICAL
trial registrationNCT04458506.
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