Embedded and Impacted TeethPDCNCT05067712
The Effect of Surgical Technique on PDC
A study testing Open Surgical Exposure Technique and Closed Surgical Exposure Technique in people with Embedded and Impacted Teeth, run by University of Oslo at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 9 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Embedded and Impacted Teeth
- What is being tested?
- Open Surgical Exposure Technique and Closed Surgical Exposure Technique
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Nov 2017to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Norway1 site
Det Odontologiske Fakultet, avdelingen for kjeveortopedi
Oslo, 0455
Sweden1 site
Odontologiska Institutionen, avdelingen för ortodonti
Jönköping, 551 11
About this study
Official title: Treatment of Palatally Displaced Maxillary Canines - a Controlled Randomized Clinical Trial
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.
Read more
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.
Read the detailed description
Consecutive patients planned for surgical exposure of uni- or bilateral palatally impacted canines of two centers, are invited to participate in the Trial. The centers are the University Orthodontic Departments of Oslo, Norway, and Jonkoping, Sweden.
Potential participant patients and their parents are given verbal and written information about the Trial and Informed Consent is obtained.
Participants are randomly allocated to one of two interventions by use of Permuted Block Randomization in order to maintain equal allocations across treatment groups. Allocation concealment is held by one individual in each center that is not involved in the study. No stratification is made for age or gender in the two groups.
If the maxillary deciduous canine is present at the time of the surgery, the tooth is removed together with the exposure of the impacted canine.
Before entering the surgery room, participants answer a first questionnaire on whether they are experiencing pain or discomfort (measured in VAS-scales) in the area of the impacted canine and whether they have taken analgesics. The questionnaire is filled in and delivered back before entering the surgery room. After the surgical exposure, verbal and written information and recommendations on chlorhexidine mouth rinse and analgesic consumption are given. A second questionnaire is then handed out for participants to self-report the pain-discomfort they experienced during surgery, and are experiencing in the evening the same day and the following seven days together with the analgesic consumption. The second questionnaire is delivered back to the clinic at the post-surgical control.
At the post-surgical control, participants receive a third questionnaire where they self-report the pain-discomfort they experienced during and after sutures (closed technique) and packing (open technique) are removed.
After the surgical exposure with the open technique, the canine is left to erupt spontaneously. Participants are follow-up by the orthodontist until the canine has erupted enough (approximately ½ - 1/3 of the crown above the level of the palatal mucosa) to bond an attachment to the crown. The canine then starts to be moved into alignment in the dental arch above the mucosa with orthodontic appliances.
After the surgical exposure with the closed technique, the impacted canine starts to be moved with orthodontic appliances within 2 weeks after surgery. The canine is moved into alignment in the dental arch through the mucosa.
From the completion of the surgical exposure phase until the previously impacted canine is orthodontically positioned in the dental arch, similar questionnaires are handed out to the participants in both treatment groups every second/ third orthodontic control.
The participants are followed until the active orthodontic treatment is finished and orthodontic retainers bonded.
Schedule/ registrations:
Before the surgical exposure phase of treatment (T0)
- Clinical anamnesis
- Routine dental clinical examination. Assessment of periodontal pocket depth, gingival bleeding on probing, gingival recession in the lateral incisor in the impacted and nonimpacted contralateral side.
- Study models. Assessment of occlusion traits, presence of maxillary deciduous canine.
- Panoramic radiograph. Assessment of the position of the impacted canine: mesial position, mesial inclination, and distance to the occlusal line according to Ericson and Kurol.
- Cephalogram. Assessment of upper incisor sagittal inclination.
- CBCT (cone beam computed tomography). Assessment of the exact impacted canine position, size of the impacted canine's follicle, crestal bone height in the lateral incisor in the impacted and nonimpacted contra lateral side, root resorption of the impacted canine, lateral incisor, and first premolar in the impacted and nonimpacted contra lateral side
Surgical exposure day (T1)
- Questionnaires are handed out to the participants for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption : (1) before surgery same day (2) after surgery same day and following 7 days, (3) post-surgery control same day and following 7 days.
- Registrations at the surgery: duration of the operation, complications, depth of the impacted canine from the mucosa surface.
The previously palatally impacted canine has erupted (approximately 1/3-1/2 canine crown above palatal mucosa) (T2)
- Questionnaires are handed out to participants between T1 and T2 for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption the same day and following 7 days after every second/ third orthodontic control
- Timespan T1-T2
- Complications associated with the eruption of the canine since surgery
The previously palatally impacted canine is aligned in the dental arch and ligated to a 0.016 X 0.022 nickel-titanium / standard steel archwire in the 0.018- appliance system or a 0.019 X 0.025 nickel-titanium / standard steed archwire in the 0.022- appliance system (T3)
- CBCT (cone beam computed tomography). Assessment of the position of the canine root, crestal bone height in the canine, lateral incisor, and first premolar in the impacted and nonimpacted contra lateral side, root resorption of the impacted canine, incisors, and first premolar in the impacted and nonimpacted contra lateral side
- Questionnaires are handed out to participants between T2 and T3 for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption the same day and following 7 days after every second/ third orthodontic control
- Timespan T2-T3
- Complications associated with the orthodontic alignment of the previously impacted canine into the dental arch.
The active orthodontic treatment is finished and an orthodontic retainer is fitted (T4)
- Routine clinical examination. Assessment of periodontal pocket depth, gingival bleeding on probing, gingival recession in the canine, incisors and first premolar in the impacted and nonimpacted contra lateral side.
- Study models. Assessment of occlusion traits.
- Panoramic radiograph. Assessment of root parallelism, root resorption.
- Cephalogram. Assessment of upper incisor sagittal inclination.
Except for the CBCT examinations and questionnaires, all the examinations and treatments performed in this trial are the routine examinations and treatments of palatally impacted maxillary canines performed in Norway and Sweeden. All the surgical exposures and orthodontic treatments are performed by or under the supervision of the same specialist in oral surgery and orthodontics, respectively, in each center, with many years of experience.
- Conditions
- Embedded and Impacted Teeth
- Being tested
- Open Surgical Exposure Technique, Closed Surgical Exposure Technique
- Medical subject headings
- Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Surgical Exposure TechniqueProcedure or surgery
- 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.
Closed Surgical Exposure TechniqueProcedure or surgery
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: Closed Surgical Exposure Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Within 3 years from surgery
Secondary outcomes (1)
Canine eruption time
Time span from the surgery until 1/3 to 1/2 of the canine crown is above the level of the palatal mucosa
Measured: Within 1,5 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start25 Nov 2017
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Embedded and Impacted TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oslo
- Sponsor type
- University, hospital or other
- Collaborators
- Jonkoping County Hospital
- Responsible party
- Principal investigator, Lucete Fernandes faerovig, University of Oslo
- Investigators
- Lucete Fe Færøvig, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067712
- Sponsor's protocol ID
- 2015715
- Acronym
- PDC
- Status last verified
- Feb 2024
- First submitted
- 3 Jun 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ericson S, Kurol J. Radiographic examination of ectopically erupting maxillary canines. Am J Orthod Dentofacial Orthop. 1987 Jun;91(6):483-92. doi: 10.1016/0889-5406(87)90005-9.
PubMed 3473928Bishara SE. Impacted maxillary canines: a review. Am J Orthod Dentofacial Orthop. 1992 Feb;101(2):159-71. doi: 10.1016/0889-5406(92)70008-X.
PubMed 1739070Peck S, Peck L, Kataja M. The palatally displaced canine as a dental anomaly of genetic origin. Angle Orthod. 1994;64(4):249-56. doi: 10.1043/0003-3219(1994)0642.0.CO;2.
PubMed 7978519Walker L, Enciso R, Mah J. Three-dimensional localization of maxillary canines with cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):418-23. doi: 10.1016/j.ajodo.2004.04.033.
PubMed 16214621Stewart JA, Heo G, Glover KE, Williamson PC, Lam EW, Major PW. Factors that relate to treatment duration for patients with palatally impacted maxillary canines. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):216-25. doi: 10.1067/mod.2001.110989.
PubMed 11244415Spencer 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.
PubMed 19889488Pearson 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.
PubMed 9386337Counihan K, Al-Awadhi EA, Butler J. Guidelines for the assessment of the impacted maxillary canine. Dent Update. 2013 Nov;40(9):770-2, 775-7. doi: 10.12968/denu.2013.40.9.770.
PubMed 24386769Burden DJ, Mullally BH, Robinson SN. Palatally ectopic canines: closed eruption versus open eruption. Am J Orthod Dentofacial Orthop. 1999 Jun;115(6):640-4. doi: 10.1016/s0889-5406(99)70289-1.
PubMed 10358246Parkin 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.
PubMed 18843740Wisth PJ, Norderval K, Booe OE. Comparison of two surgical methods in combined surgical-orthodontic correction of impacted maxillary canines. Acta Odontol Scand. 1976;34(1):53-7. doi: 10.3109/00016357609026558.
PubMed 1066949Gharaibeh 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.
PubMed 18547839Parkin 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.
PubMed 22677328Chaushu S, Becker A, Zeltser R, Branski S, Vasker N, Chaushu G. Patients perception of recovery after exposure of impacted teeth: a comparison of closed- versus open-eruption techniques. J Oral Maxillofac Surg. 2005 Mar;63(3):323-9. doi: 10.1016/j.joms.2004.11.007.
PubMed 15742281Caminiti MF, Sandor GK, Giambattistini C, Tompson B. Outcomes of the surgical exposure, bonding and eruption of 82 impacted maxillary canines. J Can Dent Assoc. 1998 Sep;64(8):572-4, 576-9.
PubMed 9785687
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Palatally Displaced Maxillary Canines - a Controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05067712
- Acronym / sponsor ID
- PDC / 2015715
- Conditions
- Embedded and Impacted Teeth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of OsloUniversity, hospital or other
- Collaborators
- Jonkoping County Hospital
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Consecutive patients planned for surgical exposure of uni- or bilateral palatally impacted canines of two centers, are invited to participate in the Trial. The centers are the University Orthodontic Departments of Oslo, Norway, and Jonkoping, Sweden.
Potential participant patients and their parents are given verbal and written information about the Trial and Informed Consent is obtained.
Participants are randomly allocated to one of two interventions by use of Permuted Block Randomization in order to maintain equal allocations across treatment groups. Allocation concealment is held by one individual in each center that is not involved in the study. No stratification is made for age or gender in the two groups.
If the maxillary deciduous canine is present at the time of the surgery, the tooth is removed together with the exposure of the impacted canine.
Before entering the surgery room, participants answer a first questionnaire on whether they are experiencing pain or discomfort (measured in VAS-scales) in the area of the impacted canine and whether they have taken analgesics. The questionnaire is filled in and delivered back before entering the surgery room. After the surgical exposure, verbal and written information and recommendations on chlorhexidine mouth rinse and analgesic consumption are given. A second questionnaire is then handed out for participants to self-report the pain-discomfort they experienced during surgery, and are experiencing in the evening the same day and the following seven days together with the analgesic consumption. The second questionnaire is delivered back to the clinic at the post-surgical control.
At the post-surgical control, participants receive a third questionnaire where they self-report the pain-discomfort they experienced during and after sutures (closed technique) and packing (open technique) are removed.
After the surgical exposure with the open technique, the canine is left to erupt spontaneously. Participants are follow-up by the orthodontist until the canine has erupted enough (approximately ½ - 1/3 of the crown above the level of the palatal mucosa) to bond an attachment to the crown. The canine then starts to be moved into alignment in the dental arch above the mucosa with orthodontic appliances.
After the surgical exposure with the closed technique, the impacted canine starts to be moved with orthodontic appliances within 2 weeks after surgery. The canine is moved into alignment in the dental arch through the mucosa.
From the completion of the surgical exposure phase until the previously impacted canine is orthodontically positioned in the dental arch, similar questionnaires are handed out to the participants in both treatment groups every second/ third orthodontic control.
The participants are followed until the active orthodontic treatment is finished and orthodontic retainers bonded.
Schedule/ registrations:
Before the surgical exposure phase of treatment (T0)
- Clinical anamnesis
- Routine dental clinical examination. Assessment of periodontal pocket depth, gingival bleeding on probing, gingival recession in the lateral incisor in the impacted and nonimpacted contralateral side.
- Study models. Assessment of occlusion traits, presence of maxillary deciduous canine.
- Panoramic radiograph. Assessment of the position of the impacted canine: mesial position, mesial inclination, and distance to the occlusal line according to Ericson and Kurol.
- Cephalogram. Assessment of upper incisor sagittal inclination.
- CBCT (cone beam computed tomography). Assessment of the exact impacted canine position, size of the impacted canine's follicle, crestal bone height in the lateral incisor in the impacted and nonimpacted contra lateral side, root resorption of the impacted canine, lateral incisor, and first premolar in the impacted and nonimpacted contra lateral side
Surgical exposure day (T1)
- Questionnaires are handed out to the participants for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption : (1) before surgery same day (2) after surgery same day and following 7 days, (3) post-surgery control same day and following 7 days.
- Registrations at the surgery: duration of the operation, complications, depth of the impacted canine from the mucosa surface.
The previously palatally impacted canine has erupted (approximately 1/3-1/2 canine crown above palatal mucosa) (T2)
- Questionnaires are handed out to participants between T1 and T2 for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption the same day and following 7 days after every second/ third orthodontic control
- Timespan T1-T2
- Complications associated with the eruption of the canine since surgery
The previously palatally impacted canine is aligned in the dental arch and ligated to a 0.016 X 0.022 nickel-titanium / standard steel archwire in the 0.018- appliance system or a 0.019 X 0.025 nickel-titanium / standard steed archwire in the 0.022- appliance system (T3)
- CBCT (cone beam computed tomography). Assessment of the position of the canine root, crestal bone height in the canine, lateral incisor, and first premolar in the impacted and nonimpacted contra lateral side, root resorption of the impacted canine, incisors, and first premolar in the impacted and nonimpacted contra lateral side
- Questionnaires are handed out to participants between T2 and T3 for assessment of pain and discomfort (measured on VAS-scale) and analgesic consumption the same day and following 7 days after every second/ third orthodontic control
- Timespan T2-T3
- Complications associated with the orthodontic alignment of the previously impacted canine into the dental arch.
The active orthodontic treatment is finished and an orthodontic retainer is fitted (T4)
- Routine clinical examination. Assessment of periodontal pocket depth, gingival bleeding on probing, gingival recession in the canine, incisors and first premolar in the impacted and nonimpacted contra lateral side.
- Study models. Assessment of occlusion traits.
- Panoramic radiograph. Assessment of root parallelism, root resorption.
- Cephalogram. Assessment of upper incisor sagittal inclination.
Except for the CBCT examinations and questionnaires, all the examinations and treatments performed in this trial are the routine examinations and treatments of palatally impacted maxillary canines performed in Norway and Sweeden. All the surgical exposures and orthodontic treatments are performed by or under the supervision of the same specialist in oral surgery and orthodontics, respectively, in each center, with many years of experience.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open Surgical Exposure Technique | Active comparator | Procedure: Open Surgical Exposure TechniqueAfter randomization, the PDC allocated to this arm is surgically exposed with the Open Technique followed by the Orthodontic Treatment phase |
| Closed Surgical Exposure Technique | Active comparator | Procedure: Closed Surgical Exposure TechniqueAfter randomization, the PDC allocated to this arm is surgically exposure with the Closed technique followed by the Orthodontic Treatment phase. |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open Surgical Exposure Technique* 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. | Procedure or surgery | Open Surgical Exposure Technique |
| Closed Surgical Exposure Technique* 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. | Procedure or surgery | Closed Surgical Exposure Technique |
Primary outcome
Success of treatment
Time frame: Within 3 years from surgery
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
Patient's perceptions of pain-discomfort experience and analgesic consumption
Time frame: Within 3 years from surgery
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.
1 secondary outcome
Canine eruption time
Time frame: Within 1,5 years from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 3473928Ericson S, Kurol J. Radiographic examination of ectopically erupting maxillary canines. Am J Orthod Dentofacial Orthop. 1987 Jun;91(6):483-92. doi: 10.1016/0889-5406(87)90005-9.
- Background: PubMed 1739070Bishara SE. Impacted maxillary canines: a review. Am J Orthod Dentofacial Orthop. 1992 Feb;101(2):159-71. doi: 10.1016/0889-5406(92)70008-X.
- Background: PubMed 7978519Peck S, Peck L, Kataja M. The palatally displaced canine as a dental anomaly of genetic origin. Angle Orthod. 1994;64(4):249-56. doi: 10.1043/0003-3219(1994)0642.0.CO;2.
- Background: PubMed 16214621Walker L, Enciso R, Mah J. Three-dimensional localization of maxillary canines with cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2005 Oct;128(4):418-23. doi: 10.1016/j.ajodo.2004.04.033.
- Background: PubMed 11244415Stewart JA, Heo G, Glover KE, Williamson PC, Lam EW, Major PW. Factors that relate to treatment duration for patients with palatally impacted maxillary canines. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):216-25. doi: 10.1067/mod.2001.110989.
- Background: PubMed 19889488Spencer 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.
- Background: PubMed 9386337Pearson 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.
- Background: PubMed 24386769Counihan K, Al-Awadhi EA, Butler J. Guidelines for the assessment of the impacted maxillary canine. Dent Update. 2013 Nov;40(9):770-2, 775-7. doi: 10.12968/denu.2013.40.9.770.
- Background: PubMed 10358246Burden DJ, Mullally BH, Robinson SN. Palatally ectopic canines: closed eruption versus open eruption. Am J Orthod Dentofacial Orthop. 1999 Jun;115(6):640-4. doi: 10.1016/s0889-5406(99)70289-1.
- Background: PubMed 18843740Parkin 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.
- Background: PubMed 1066949Wisth PJ, Norderval K, Booe OE. Comparison of two surgical methods in combined surgical-orthodontic correction of impacted maxillary canines. Acta Odontol Scand. 1976;34(1):53-7. doi: 10.3109/00016357609026558.
- Background: PubMed 18547839Gharaibeh 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucete Fe Færøvig principal investigator
University of Oslo
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Surgical Exposure Technique and Closed Surgical Exposure Technique in people with Embedded and Impacted Teeth, run by University of Oslo at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of treatment (time frame: Within 3 years from surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067712, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2024; AzTrials last refreshed its copy on 6 Nov 2026.