The Impact of Surgical Technique on PDC

NCT02186548 | Completed

• 1 other identifier: ÖLL-2013/091
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Tooth, Impacted

Outcome Measures

Primary Outcomes (1)

• Treatment success; the previous impacted canine is positioned in the dental arch

  "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.

  Within 3 years after surgery

Secondary Outcomes (1)

• Duration from surgery until the previous impacted canine has erupted into the mouth

  Within 1,5 year from surgery

Other Outcomes (6)

• Presence, type and number of complications/failures associated with the operation techniques

  Within 1,5 years from surgery

• Operation time (hours, minutes)

  Within 6 months from allocation

• Estimation of total treatment costs

  Within 3,5 years from surgery

Study Arms (2)

Closed surgical technique

ACTIVE COMPARATOR

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

Open surgical technique

ACTIVE COMPARATOR

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

Interventions

Closed surgical technique PROCEDURE

* 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

Closed surgical technique

Open surgical technique PROCEDURE

* 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

Open surgical technique

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Örebro County Council: lead
• Sormland County Council, Sweden: collaborator
• Jonkoping County Hospital: collaborator

Study Sites (3)

Tandregleringen, Kungsgatan. 21A

Eskilstuna, 631 88, Sweden

Location

Odontologiska institutionen, avdelningen för ortodonti, Hermansvägen 5

Jönköping, 551 11, Sweden

Location

Centrum för specialisttandvård, avdelningen för ortodonti, Klostergatan 26

Örebro, 703 61, Sweden

Location

Related Publications (23)

• Parkin N, Benson PE, Thind B, Shah A. Open versus closed surgical exposure of canine teeth that are displaced in the roof of the mouth. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006966. doi: 10.1002/14651858.CD006966.pub2.

  PMID: 18843740 BACKGROUND

• Spencer HR, Ramsey R, Ponduri S, Brennan PA. Exposure of unerupted palatal canines: a survey of current practice in the United Kingdom, and experience of a gingival-sparing procedure. Br J Oral Maxillofac Surg. 2010 Dec;48(8):641-4. doi: 10.1016/j.bjoms.2009.08.032. Epub 2009 Nov 3.

  PMID: 19889488 BACKGROUND

• Parkin NA, Deery C, Smith AM, Tinsley D, Sandler J, Benson PE. No difference in surgical outcomes between open and closed exposure of palatally displaced maxillary canines. J Oral Maxillofac Surg. 2012 Sep;70(9):2026-34. doi: 10.1016/j.joms.2012.02.028. Epub 2012 Jun 6.

  PMID: 22677328 BACKGROUND

• Gharaibeh TM, Al-Nimri KS. Postoperative pain after surgical exposure of palatally impacted canines: closed-eruption versus open-eruption, a prospective randomized study. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Sep;106(3):339-42. doi: 10.1016/j.tripleo.2007.12.025. Epub 2008 Jun 11.

  PMID: 18547839 BACKGROUND

• Pearson MH, Robinson SN, Reed R, Birnie DJ, Zaki GA. Management of palatally impacted canines: the findings of a collaborative study. Eur J Orthod. 1997 Oct;19(5):511-5. doi: 10.1093/ejo/19.5.511.

  PMID: 9386337 BACKGROUND

• Caprioglio A, Vanni A, Bolamperti L. Long-term periodontal response to orthodontic treatment of palatally impacted maxillary canines. Eur J Orthod. 2013 Jun;35(3):323-8. doi: 10.1093/ejo/cjs020. Epub 2012 Apr 24.

  PMID: 22531665 BACKGROUND

• Fleming PS, Scott P, Heidari N, Dibiase AT. Influence of radiographic position of ectopic canines on the duration of orthodontic treatment. Angle Orthod. 2009 May;79(3):442-6. doi: 10.2319/042708-238.1.

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  PMID: 18251594 BACKGROUND

• Becker A, Kohavi D, Zilberman Y. Periodontal status following the alignment of palatally impacted canine teeth. Am J Orthod. 1983 Oct;84(4):332-6. doi: 10.1016/s0002-9416(83)90349-4.

  PMID: 6578683 BACKGROUND

• Hansson C, Rindler A. Periodontal conditions following surgical and orthodontic treatment of palatally impacted maxillary canines--a follow-up study. Angle Orthod. 1998 Apr;68(2):167-72. doi: 10.1043/0003-3219(1998)0682.3.CO;2.

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  PMID: 15210926 BACKGROUND

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• Cuthbert MI, Melamed BG. A screening device: children at risk for dental fears and management problems. ASDC J Dent Child. 1982 Nov-Dec;49(6):432-6. No abstract available.

  PMID: 6960031 BACKGROUND

• BJOERK A, KREBS A, SOLOW B. A METHOD FOR EPIDEMIOLOGICAL REGISTRATION OF MALOCCLUSION. Acta Odontol Scand. 1964 Feb;22:27-41. doi: 10.3109/00016356408993963. No abstract available.

  PMID: 14158468 BACKGROUND

• Ericson S, Kurol J. Early treatment of palatally erupting maxillary canines by extraction of the primary canines. Eur J Orthod. 1988 Nov;10(4):283-95. doi: 10.1093/ejo/10.4.283. No abstract available.

  PMID: 3208843 BACKGROUND

• Bjorksved M, Ryen L, Lindsten R, Bazargani F. Open and closed surgical exposure of palatally displaced canines: a cost-minimization analysis of a multicentre, randomized controlled trial. Eur J Orthod. 2021 Oct 4;43(5):498-505. doi: 10.1093/ejo/cjab052.

  PMID: 34386824 DERIVED

• Bjorksved M, Arnrup K, Bazargani SM, Lund H, Magnusson A, Magnuson A, Lindsten R, Bazargani F. Open vs closed surgical exposure of palatally displaced canines: a comparison of clinical and patient-reported outcomes-a multicentre, randomized controlled trial. Eur J Orthod. 2021 Oct 4;43(5):487-497. doi: 10.1093/ejo/cjab015.

  PMID: 34114630 DERIVED

• Bjorksved M, Arnrup K, Lindsten R, Magnusson A, Sundell AL, Gustafsson A, Bazargani F. Closed vs open surgical exposure of palatally displaced canines: surgery time, postoperative complications, and patients' perceptions: a multicentre, randomized, controlled trial. Eur J Orthod. 2018 Nov 30;40(6):626-635. doi: 10.1093/ejo/cjy070.

  PMID: 30321323 DERIVED

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Farhan Bazargani, DDS, PhD

  Centrum för specialisttandvård, avdelningen för ortodonti, Klostergatan 26, 703 61 Örebro. Tel: 0046-019-6024050

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 10, 2014
• Study Start: June 1, 2013
• Primary Completion: January 1, 2021
• Study Completion: February 1, 2021
• Last Updated: September 10, 2021

Record last verified: 2021-09

Locations

SE (3)