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Recruiting NCT06267989

NCT06267989 The Effectiveness of Early Intervention to Correct the Position of PDC:s

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Clinical Trial Summary
NCT ID NCT06267989
Status Recruiting
Phase —
Sponsor Göteborg University
Condition Ectopic Tooth Eruption
Study Type INTERVENTIONAL
Enrollment 324 participants
Start Date 2024-10-01
Primary Completion 2030-12-30

Eligibility & Interventions

Sex All sexes
Min Age 10 Years
Max Age 12 Years
Study Type INTERVENTIONAL
Interventions
Extraction of the primary canine teethExpansion

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 324 participants in total. It began in 2024-10-01 with a primary completion date of 2030-12-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * One or both upper permanent canine teeth are not palpable or there is a pronounced difference in the eruption between the left and right side. Dental radiographs will be taken to confirm that the permanent tooth is displaced. Canines in sector 5 are going to be excluded from this trial. Exclusion Criteria: * Buccal displacement of the canine(s), missing permanent lateral incisors; severe upper arch dental crowding (\>2mm in each affected quadrant) or associated pathology.

Contact & Investigator

Central Contact

Farhan Bazargani, DDS, PhD

✉ farhan.bazargani@gu.se

📞 +46707546107

Principal Investigator

Farhan Bazargani, DDS, PhD

PRINCIPAL INVESTIGATOR

Gothenburg University, Gothenburg, Sweden

Frequently Asked Questions

Who can join the NCT06267989 clinical trial?

This trial is open to participants of all sexes, aged 10 Years or older, up to 12 Years, studying Ectopic Tooth Eruption. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06267989 currently recruiting?

Yes, NCT06267989 is actively recruiting participants. Contact the research team at farhan.bazargani@gu.se for enrollment information.

Where is the NCT06267989 trial being conducted?

This trial is being conducted at Traben-Trarbach, Germany, Gothenburg, Sweden, Sheffield, United Kingdom.

Who is sponsoring the NCT06267989 clinical trial?

NCT06267989 is sponsored by Göteborg University. The principal investigator is Farhan Bazargani, DDS, PhD at Gothenburg University, Gothenburg, Sweden. The trial plans to enroll 324 participants.

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