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

NCT06267989 | Recruiting

• 1 other identifier: Gothenburg University/Göteborg
• Study Type: interventional
• Target: 324
• Locations: 3 countries
• Sites: 3

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.

Conditions

Ectopic Tooth Eruption; Palatal Expansion Technique; Randomized Clinical Trial

Outcome Measures

Primary Outcomes (1)

• Succeful eruption of the palatally displaced canines into the dental arch

  The proportion of young people who do not require surgery after 18 months from randomisation.

  18 months after intervention

Secondary Outcomes (4)

• Cost effectiveness of the interventions

  18 months

• Prevalence and severity of damage to surrounding teeth either due to the unerupted tooth or orthodontic intervention.

  18 months

• Oral Health related Quality of Life

  At baseline, 6 months and 18 months

• Cost-utility analysis

  At baseline, 6 months and 18 monts

Study Arms (3)

Extraction

ACTIVE COMPARATOR

Extraction of the primary canine

Procedure: Extraction of the primary canine teeth

Expansion

EXPERIMENTAL

Rapid maxillary expansion without extraction of the primary canine

Procedure: Expansion

Control

NO INTERVENTION

No intervention during the observation period (18 months)

Interventions

Extraction of the primary canine teeth PROCEDURE

Extraction of the primary teeth has show to be successful in some cases.

Also known as: Extraction of the baby teeth

Extraction

Expansion PROCEDURE

Expansion of the maxilla with rapid maxillary expander with no extractions

Expansion

Eligibility Criteria

• Age: 10 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Buccal displacement of the canine(s), missing permanent lateral incisors; severe upper arch dental crowding (\>2mm in each affected quadrant) or associated pathology.

Sponsors & Collaborators

• Göteborg University: lead
• University of Sheffield: collaborator
• Region Örebro County: collaborator

Study Sites (3)

Private practice

Traben-Trarbach, Germany

NOT YET RECRUITING

Gothenbrug University

Gothenburg, Sweden

RECRUITING

University of Sheffield

Sheffield, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Tooth Eruption, Ectopic

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Farhan Bazargani, DDS, PhD

  Gothenburg University, Gothenburg, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farhan Bazargani, DDS, PhD

CONTACT

+46707546107; farhan.bazargani@gu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2024
• First Posted: February 20, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); SE (1); DE (1)