The Effect of Surgical Technique on PDC

NCT05067712 | Active Not Recruiting DMC

• 1 other identifier: 2015715
• Study Type: interventional
• Target: 88
• Locations: 2 countries
• Sites: 2

Brief Summary

Permanent maxillary canines are the second teeth that most commonly assume ectopic positions after the third molars. They are diagnosed as impacted and have an incidence of 1 % to 3% In their ectopic path of eruption, they can cause damage (resorption) of the adjacent roots, a severe complication that may lead to the loss of anterior teeth. When cone-beam computed tomography (CT) scanning is used for diagnose, root resorption is detected in two-thirds of the lateral incisors adjacent to impacted maxillary canines before treatment. The treatment of this condition comprises two stages: a surgical intervention to uncover the canine crown followed by orthodontic treatment to move the canine into correct position. The surgical intervention commonly involves two different techniques: the open and the closed technique. The open technique procedure involves removing the bone and mucosa covering the crown of the canine. The exposed crown is left uncovered and a pack is placed over the area to avoid overgrowth of tissue. When enough spontaneous eruption of the canine has occurred, an orthodontic attachment is bonded to the crown and the tooth is moved above the mucosa with orthodontic appliances into the correct position. The closed technique procedure involves bonding an orthodontic attachment to the crown with a chain after exposing the canine during the surgery. The palatal flap is sutured back covering the exposed crown and the chain is left through the palatal mucosa free in the oral cavity. Shortly after, the canine is forced to erupt through the palatal mucosa and moved into the correct position with orthodontic appliances. The purpose of this prospective randomized clinical trial is to compare outcome variables between the Open and Closed surgical exposure techniques regarding the success of treatment, patient's perceptions of pain and discomfort experienced and analgesic consumption, treatment time, and complications. The null hypothesis is that similar outcomes occur when the surgical exposure of palatally impacted canines is performed by using the open or the closed surgical technique.

Conditions

Embedded and Impacted Teeth

Outcome Measures

Primary Outcomes (2)

• Success of treatment

  The canine is aligned in the dental arch. "Aligned in the dental arch" meaning the canine being ligated to a 0.016 X .0.22 nickel- titanium/ standard steel in a 0.018-appliance system or to a 0.019 X 0.025 nickel-titanium/ standard steel arch-wire in a 0.022- appliance system

  Within 3 years from surgery

• Patient's perceptions of pain-discomfort experience and analgesic consumption

  Perceptions of pain-discomfort experienced and analgesic consumption are self reported on a 100 mm visual analogue scale (VAS) and questionnaires in the first evening and the following 7 evenings, after surgery, after suture and pack removal and after every second/ third orthodontic activation.

  Within 3 years from surgery

Secondary Outcomes (1)

• Canine eruption time

  Within 1,5 years from surgery

Other Outcomes (3)

• Surgery operation time

  1,5 hours

• Complications associated with the surgical technique

  Within 1,5 years from the surgery

• Duration of orthodontic treatment

  Within 3 years from the surgery

Study Arms (2)

Open Surgical Exposure Technique

ACTIVE COMPARATOR

After randomization, the PDC allocated to this arm is surgically exposed with the Open Technique followed by the Orthodontic Treatment phase

Procedure: Open Surgical Exposure Technique

Closed Surgical Exposure Technique

ACTIVE COMPARATOR

After randomization, the PDC allocated to this arm is surgically exposure with the Closed technique followed by the Orthodontic Treatment phase.

Procedure: Closed Surgical Exposure Technique

Interventions

Open Surgical Exposure Technique PROCEDURE

* A mucoperiosteal palatal flap is elevated off the bone from the premolar to the midline * The bone covering the crown aspect of the canine is removed until the largest diameter of the crown is exposed * Follicular tissue is removed from the exposed crown area * The flap is repositioned back and sutured * The area over the exposed canine crown is excised leaving a window with the crown uncovered. * If the tooth is deeply embedded in the bone, a dressing is placed over the uncovered crown and kept in place with sutures. * The extraction of the primary canine (if present) is made before or in connection with the surgical exposure. * Ten to fifteen days later the dressing and sutures are removed and the tooth is left to erupt autonomously. * When the canine has spontaneously erupted above the palatal mucosa an attachment is bonded to the crown and the canine is moved into alignment in the dental arch above the mucosa with orthodontic appliances.

Open Surgical Exposure Technique

Closed Surgical Exposure Technique PROCEDURE

* A mucoperiosteal palatal flap is elevated off the bone from the premolar to the midline * The bone covering the crown aspect of the canine is removed until the largest diameter of the crown is exposed. * Follicular tissue is removed from the exposed crown area. * An attachment with a chain is bonded to the exposed canine crown. * The flap is repositioned back and sutured to cover the exposed crown leaving the chain through the palatal mucosa free in the oral cavity * The extraction of the primary canine (if present) made before or in connection with the surgical exposure * Ten to fifteen days later the sutures are removed. * Within days, traction is applied to the canine with orthodontic appliances by means of the chain, and the canine is pulled through the palatal mucosa out to the oral cavity and into alignment in the dental arch.

Closed Surgical Exposure Technique

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Consecutive patients diagnosed with palatally impacted canine with a sagittal position in Zone 2-4 as documented on panoramic radiographs according to the criteria proposed by Ericson and Kurol,1988, planned to start treatment with surgical exposure of the impacted canine.
• Patients with uni- or bilateral impacted canines are included. In bilateral impaction cases, the more severely positioned impacted canine according to the Zone (Zone 2 - 4) is included in the trial.
• No restriction of presenting malocclusion
• Dental developmental stage: Maxillary DS2M1 and DS3M2 according to Bjork.
• Age not older than 16 years at surgery

You may not qualify if:

• Agenesis of lateral incisors on the impaction side
• Peg-shaped lateral incisors on the impaction side
• Previous orthodontic treatment
• Subjects with craniofacial deformity/ syndromes
• Documented learning disability
• Communication problems related to the language when an interpreter is needed
• Sagittal position of the impacted canine in Zone 5, according to Ericson and Kurol, documented on panoramic radiographs.

Sponsors & Collaborators

• University of Oslo: lead
• Jonkoping County Hospital: collaborator

Study Sites (2)

Det Odontologiske Fakultet, avdelingen for kjeveortopedi

Oslo, 0455, Norway

Location

Odontologiska Institutionen, avdelingen för ortodonti

Jönköping, 551 11, Sweden

Location

Related Publications (36)

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  PMID: 40157786 DERIVED

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Lucete Fe Færøvig

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: October 5, 2021
• Study Start: November 25, 2017
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Locations

NO (1); SE (1)