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The Effectiveness of Early Intervention to Correct the Position of PDC:s

Study acronym: PDC
StatusRecruiting
PhaseNot applicable
Started2024-10-01
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 36 months later Dec 30, 2027 → Dec 30, 2030
See other at-risk trials from Göteborg University

Amendment history

2026-09-08
critical
Study Status v4
Primary completion pushed: 2027-12-30 → 2030-12-30
Completion pushed: 2027-12-30 → 2032-12-30
2025-04-22
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v3
Study sitescontacts updated at 1 of 3 sites
2024-12-11
minor
Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Study Design, Outcome Measures, Contacts/Locations v2
Start date2024-02-12→2024-10-01
Enrollment target318→324
Study sites1→3
Lead sponsorRegion Örebro County→Göteborg University
Secondary endpoints2 to 4 entries
Oral Health related Quality of Life Cost-utility analysis
Study description+281 characters
[...] nd the UK (Sheffield). Target Population: Children, aged 10-1211 years. Inclusion criteria: One or both upper permanent cani [...] mple size calculation suggests that we will need to recruit 300324 children (100108 per group), assuming a dropout rate of 2015%. Research questions The study aim is to investigate whethe [...] ion (primary outcome). Methods Population Children, aged 10-1211 years with at least one palatally displaced maxillary perma [...] Secondary outcomes will include patient reported outcomes: • The cost-effectivenessIncidence of theDamage: interventions OtherIs secondarythere outcomesa willhigher [...]
Collaborators+44 characters
University of Sheffield Region Örebro County
2024-02-20
minor
Study Status, Study Description v1
Study description+8,201 characters
Design: A multicentre, parallel 3-group, randomised clinical trial. Setting: Orthodontic Departments in Sweden (5 centres), Germany (5 centres) and the UK (Sheffield). Target Population: Children, aged 10-12 years. Inclusion criteria: One or both upper permanent canine teeth are not palpable or ther [...]
2024-02-12
minor
Original filing
Approximately 2-3% of children will have problems with one or both of their permanent or 'adult' canine teeth in the upper jaw. These canine teeth sometimes fail to erupt properly, because they are displaced into the roof of the mouth or palate. These are known as palatally displaced canines, PDC, (Brin et al., 1986, Ericson and Kurol, 1987). In addition to failing to erupt, displaced teeth can cause problems, such as damage to the roots or displacement of the neighbouring teeth (Ericson and Kurol, 1988a, Ericson and Kurol, 2000, Falahat et al., 2008). It has been suggested that if the primary ('baby' or 'milk') canine is extracted at an appropriate time in a child with a suspected palatally displaced canine, then the displaced tooth might spontaneously correct its position (Ericson and Kurol, 1988b) and the extraction of the baby canine when a clinician suspects that the adult canine is displaced has become accepted clinical practice (Short, 2009). This appears to be on the basis of one report of a series of 35 children who received the intervention and no control group (Ericson and Kurol, 1988b). Two recent systematic reviews have examined the evidence for the effectiveness of removal of the primary canine with the aim of correcting the eruption path of a palatally displaced canine. A recent systematic review published in The Cochrane Library in 2021 (Benson et al., 2021) noted that the evidence for any intervention to correct the eruption path of a displaced permanent canine is weak and further research is required. Numerous problems with the reported studies were identified by both reviews. Other authors have suggested that using a RME (Rapid Maxillary expansion) or headgrear (EOT) to create sufficient space within the dental arch for the permanent canine tooth will encourage the tooth to erupt (Baccetti et al., 2011). This approach might be less traumatic to a child who may have had no experience of dental treatment, other than routine check-ups. If either or both approaches are shown to be effective then their widespread use would be advantageous to both the child and the healthcare provider, because the need for an operation, under general anaesthetic, to uncover the tooth and extensive brace treatment to straighten the tooth will be avoided.
Trial Details
NCT Number NCT06267989
Lead Sponsor Göteborg University
Collaborators: University of Sheffield, Region Örebro County
Conditions Ectopic Tooth Eruption, Palatal Expansion Technique, Randomized Clinical Trial
Enrollment 324 participants
Start Date 2024-10-01
Primary Completion 2030-12-30 (estimated)
Study Completion 2032-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-09