Trial record 1 of 38 for:    PDC
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The Impact of Surgical Technique on PDC

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Örebro County Council
Sponsor:
Collaborators:
Sormland County Council, Sweden
Jonkoping County Hospital
Information provided by (Responsible Party):
Margitha Björksved, Örebro County Council
ClinicalTrials.gov Identifier:
NCT02186548
First received: July 7, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In approximately 2% of the Swedish population they fail to erupt, and are then referred to as impacted. One severe complication of impacted maxillary canines is damage (root resorption) to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth are lost. If the impaction is detected early (at 9-10 years of age), the recommended treatment is to extract the deciduous canine, to help the permanent canine to resolve its unfavorable position. If there is no improvement of the position of the canine 1 year after the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine into correct position.

Two different main principles of surgical exposure in palatally impacted maxillary permanent canines are the so called closed versus open surgical techniques.

Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap dissected off the bone. The bone covering the canine is being removed and an attachment with a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The canine is orthodontically moved beneath the palatal mucosa by forced eruption.

Open technique involves surgically uncovering of the canine, removing a window of tissue around it and placing pack to cover the exposed area. Then the treatment approaches vary depending on whether the attachment with a chain is bonded to the exposed tooth at surgery or if spontaneous eruption of the palatally impacted canine is expected postsurgically. In both alternatives orthodontic force is applied via the chain and the canine is orthodontically moved above the mucosa. These two techniques of surgical exposure of palatally impacted canines seem to be the two routinely used in Sweden.

The purposes of this study are to examine, describe and compare the treatment outcomes in regard to success and duration of treatment, complications, side effects, cost-benefit aspects and patients´ perceptions in closed versus open surgical exposure techniques, in cases with palatally impacted canines.

The objective is to test the null hypothesis that there are no differences in the above outcomes between open or closed surgical exposure of palatally impacted canines.


Condition Intervention
Tooth, Impacted
Procedure: Closed surgical technique
Procedure: Open surgical technique

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by Örebro County Council:

Primary Outcome Measures:
  • Treatment success; the previous impacted canine is positioned in the dental arch [ Time Frame: Within 3 years after surgery ] [ Designated as safety issue: No ]
    "Positioned in the dental arch"; here meaning that the previous impacted canine has been treated with fixed orthodontic braces and is inligated in .016x.022 nickel titanium/ standard steel arch-wire in a .018- appliance system and .019x.025 nickel-titanium/ standard steel arch-wire in a .022- appliance system.


Secondary Outcome Measures:
  • Duration from surgery until the previous impacted canine has erupted into the mouth [ Time Frame: Within 1,5 year from surgery ] [ Designated as safety issue: No ]
    "Erupted into the mouth"; here meaning that approximately ⅓-½ of the clinical crown of the impacted canine is exposed intraorally.


Other Outcome Measures:
  • Presence, type and number of complications/failures associated with the operation techniques [ Time Frame: Within 1,5 years from surgery ] [ Designated as safety issue: No ]
  • Operation time (hours, minutes) [ Time Frame: Within 6 months from allocation ] [ Designated as safety issue: No ]
  • Estimation of total treatment costs [ Time Frame: Within 3,5 years from surgery ] [ Designated as safety issue: No ]
  • Patients´perceptions of experienced pain, discomfort and consumption of analgesics. [ Time Frame: Within 3 years from surgery ] [ Designated as safety issue: No ]
    Patients´perceptions of experienced pain, discomfort and consumption of analgesics is registered in questionnaires at the first evening and one week after surgical exposure and every 3rd month until the impacted canine is positioned in the dental arch.

  • Presence of dental anxiety (patient) and eventual change in dental anxiety during treatment [ Time Frame: Within 3 years from surgery ] [ Designated as safety issue: No ]
    A Dental Subscale of the Children´s Fear Survey Schedule, CFSS-DS questionnaire will be handed out to the patients at three times (before start of treatment, after the impacted canine has erupted and when the canine is positioned in the dental arch). Dental anxiety and eventual change in dental anxiety will be described, compared and evaluated compared between the two surgical exposure group and individually.

  • Dental health comparison between the two groups of different surgical exposure [ Time Frame: Within 3,5 years from surgery ] [ Designated as safety issue: No ]

    Dental health is measured before start of treatment and when treatment is finished, and compared between the surgical groups and also between the impacted and non impacted side in the individual, here as:

    • Periodontal health measured as pocket depth, bleeding on probing and recession of the gingival margin (clinical routine examination)
    • Crestal bone height and eventual root resorption (cone beam computed tomography)


Estimated Enrollment: 120
Study Start Date: November 2013
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Closed surgical technique
After randomization, the PDC:s randomized to this arm, are to undergo closed surgical exposure, which is an intervention to correct the position of PDC:s.
Procedure: Closed surgical technique
  • Surgically uncovering of the impacted canine with a mucoperiosteal flap dissected off the bone
  • The bone covering the canine is being removed
  • Attachment with a chain is bonded to the exposed tooth
  • The palatal flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery
  • The canine is orthodontically moved beneath the palatal mucosa
Active Comparator: Open surgical technique
After randomization, the PDC:s randomized to this arm, are to undergo open surgical exposure, which is an intervention to correct the position of PDC:s.
Procedure: Open surgical technique
  • Surgically uncovering of the impacted canine, removing a window of tissue from around the tooth
  • Pack/filling material is applied on the tooth
  • Spontaneous eruption of the palatally impacted canine is allowed expected
  • The canine is orthodontically moved above the mucosa

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02186548

Contacts
Contact: Farhan Bazargani, DDS, PhD 0046-19-6024050 farhan.bazargani@orebroll.se
Contact: Kristina Arnrup, DDS, PhD 0046-19-6024036 kristina.arnrup@orebroll.se

Locations
Sweden
Tandregleringen, Kungsgatan. 21A Recruiting
Eskilstuna, Sweden, 631 88
Contact: Margitha Björksved, DDS    0046-16-104380    margitha.bjorksved@dll.se   
Contact: Farhan Bazargani, DDS, PhD    0046-19-6024050    farhan.bazargani@orebroll.se   
Principal Investigator: Margitha Björksved, DDS         
Odontologiska institutionen, avdelningen för ortodonti, Hermansvägen 5 Recruiting
Jönköping, Sweden, 551 11
Contact: Rune Lindsten, PhD,ass.prof    0046-36-325350    rune.lindsten@lj.se   
Contact: Farhan Bazargani, DDS, PhD    0046-19-6024050    farhan.bazargani@orebroll.se   
Principal Investigator: Rune Lindsten, DDS, PhD         
Centrum för specialisttandvård, avdelningen för ortodonti, Klostergatan 26 Recruiting
Örebro, Sweden, 703 61
Contact: Farhan Bazargani, DDS, PhD    0046-19-6024050    farhan.bazargani@orebroll.se   
Contact: Kristina Arnrup, PhD,ass.prof    0046-19-6024036    kristina.arnrup@orebroll.se   
Principal Investigator: Farhan Bazargani, DDS, PhD         
Sponsors and Collaborators
Örebro County Council
Sormland County Council, Sweden
Jonkoping County Hospital
Investigators
Study Director: Farhan Bazargani, DDS, PhD Centrum för specialisttandvård, avdelningen för ortodonti, Klostergatan 26, 703 61 Örebro. Tel: 0046-019-6024050
  More Information

Publications:

Responsible Party: Margitha Björksved, DDS, MSc, Örebro County Council
ClinicalTrials.gov Identifier: NCT02186548     History of Changes
Other Study ID Numbers: ÖLL-2013/091
Study First Received: July 7, 2014
Last Updated: July 10, 2014
Health Authority: Sweden: Regional Ethical Review Board

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014