The Impact of Surgical Technique on PDC

• Register: ClinicalTrials.gov
• Last refreshed on: 20 September 2021
• Main ID: NCT02186548
• Date of registration: 07/07/2014
• Prospective Registration: No
• Primary sponsor: Örebro County Council
• Public title: The Impact of Surgical Technique on PDC PDC
• Scientific title: Closed Versus Open Surgical Exposure of Palatally Displaced Canines (PDC); Treatment and Treatment Outcome Including Aspects of Cost-benefit and Patients´Perceptions. A Multicenter Prospective Randomized Clinical Trial
• Date of first enrolment: June 2013
• Target sample size: 120
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02186548
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Farhan Bazargani, DDS, PhD
• Affiliation: Centrum för specialisttandvård, avdelningen för ortodonti, Klostergatan 26, 703 61 Örebro. Tel: [phone]

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients with diagnosis of uni- or bilateral palatally impacted canine/-s planned for
surgical exposure at start of treatment of the impacted canines. In the bilateral
impaction cases, the impacted canine in the more severe position according to the
criteria (in Zone 2-4) proposed by Ericson and Kurol is included in the trial.

- Dental development stage: maxillary DS2M1 and DS3M2 according to Björk

- Pretreatment mesial position of the impacted canine in Zone 2-4, according to the
criteria proposed by Ericson and Kurol, documented in panoramic radiographs.

Exclusion Criteria:

- Diseases affecting the somatic and/or craniofacial growth

- Diseases not compatible with anaesthesia or surgery

- Known neuropsychiatric diagnosis or documented learning disability

- Problem to understand Swedish (patient and parent). Interpreter needed

- Patients older than 16 years of age at the year of start of treatment

- Ongoing orthodontic treatment

- Patients with agenesis of the lateral incisor in the impacted side

- Pretreatment mesial position of the impacted canine in Zone 5, according to the
criteria proposed by Ericson and Kurol, documented in panoramic radiographs

- Pretreatment vertical position of the impacted canine above the full length root of
the central incisor on the same side, according to Fleming, PS. et al.



Age minimum: 8 Years
Age maximum: 16 Years
Gender: All

Health Condition(s) or Problem(s) studied

Tooth, Impacted

Intervention(s)

Procedure: Closed surgical technique

Procedure: Open surgical technique

Primary Outcome(s)

Treatment success; the previous impacted canine is positioned in the dental arch [Time Frame: Within 3 years after surgery]

Secondary Outcome(s)

Duration from surgery until the previous impacted canine has erupted into the mouth [Time Frame: Within 1,5 year from surgery]

Secondary ID(s)

ÖLL-2013/091

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Jonkoping County Hospital

Sormland County Council, Sweden