Failure of Tooth Eruption Associated With Tooth ImpactionNCT04282772
Ectopic Eruption of Permanent First Molars
An observational study of Failure of Tooth Eruption Associated With Tooth Impaction, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
Ectopic eruption may be defined as the eruption of a permanent tooth that takes place in such a manner that a partial or a total resorption of the root(s) of an adjacent primary tooth occurs and can be noted during routine dental radiographic evaluation. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Failure of Tooth Eruption Associated With Tooth Impaction
- What is being tested?
- Impacted and Self-corrected
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 1 Feb 2020
- Phase
- Observational
- 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 11,924 child patients aged 6-10 years who attended the Pediatric Dentistry clinics at the Faculty of Dentistry, Eskisehir Osmangazi University, between March 2016 and March 2018.
Who may be able to join
- -Among the 11,924 radiographs, only the children who had at least one ectopically erupted PFM were included.
Who cannot join
- -Presence of any history of extraction due to impaction, orthodontic treatment, or caries; the presence of any craniofacial anomalies, congenital deformities, or syndromes involving dental eruption; absent adjacent PSMs; and presence of any cyst, tumor, or other pathological condition in the molar area.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskişehir Osmangazi University
Eskişehir, 26040
About this study
Official title: Ectopic Eruption of Permanent First Molars: A Retrospective Study
Ectopic eruption may be defined as the eruption of a permanent tooth that takes place in such a manner that a partial or a total resorption of the root(s) of an adjacent primary tooth occurs and can be noted during routine dental radiographic evaluation. It is a common case in mixed dentition and is usually diagnosed by a pediatric dentist. This retrospective study aimed to determine the prevalence and related factors of the ectopic eruption of permanent first molars(PFM). This retrospective study was performed using the panoramic radiographs of 11,924 child patients aged 6-10 years with at least one ectopically erupted PFM were included. The total prevalence of ectopic eruption, type, age, gender, jaw distribution, and bilateral versus unilateral occurrence were determined. The angulation of PFM, mesialization ratio of PFM, and degree of adjacent primary second molar(PSM) tooth root resorption were also assessed. The chi-square test, ANOVA was used for statistical analysis. A total of 76 ectopic eruptions were detected in the maxilla, 6 in the mandible, and 2 in both the maxilla and the mandible. In terms of the eruption status of cases with ectopic eruption, 27 were self-corrected, 51 remained impacted, and 6 were both. The impaction rate of the right upper PFMs was higher than that of others. No significant relationship was found between eruption status and degree of resorption. As a conclusion, small impaction of the PFM does not mean that the PSM lesion is also small. With substantial displacements, a proportionally diminutive lesion can exist, and vice versa.
Read the detailed description
Assessment of Angulation The angles between the axes of the PSMs and the long axes of the PFMs were measured. The angle was measured using ImageJ application (1.50 n, National Institutes of Health, Bethesda, MD, USA). The long axes were formed by a line extending parallel to the center of the tooth in an occluso-cervical manner. The vertical angle was defined as (-) or (+) according to Sun et al.The angles between the occlusal lines of the PSMs and the PFMs were measured. The horizontal angle was defined as (-) or (+) according to Sun et al.
Assessment of PSM Root Resorption The distal root resorption level of the PSM was determined using Barberia-Leache et al.'s classification2 as follows; Grade I: mild-limited resorption of the cementum or with minimum dentin penetration Grade II: moderate-resorption of the dentin without pulp exposition Grade III: severe-resorption of the distal root leading to pulp exposure Grade IV: very severe-resorption that affects the mesial root of the PSM.
Assessment of PFM Mesialization Ratio The mesiodistal size of the PFM and the amount of mesialization were measured by the Image J application to evaluate the differences between reversible and irreversible ectopic eruption. The mesiodistal size was measured from the largest part of the crown, and the amount of mesialization was measured using the distance between the drawn tangent on the distal wall of the PSM and the mesial convexity of the PFM. Afterwards, the amount of mesialization was proportioned to the mesiodistal size of the PFM.
- Being tested
- Impacted, Self-corrected
- Keywords
- Ectopic Eruption, Eruption Failure, Impacted Teeth
- Medical subject headings
- Tooth, Unerupted, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImpactedDiagnostic test
Until an active treatment for the PFM is started or the early exfoliation of PSM occurs, the tooth remains in a self-locking position
Self-correctedDiagnostic test
The ectopic erupted permanent molar can disregard the self-locking position and continue in a normal direction, but the distal root of the PSM remains more or less a significant atypical resorption
| Study group | Role | What they receive |
|---|---|---|
| Ectopic Eruption | The ectopic eruption of PFMs were classified in two ways: impacted and self-corrected. Receives: Diagnostic Test: Impacted; Diagnostic Test: Self-corrected |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of the ectopic eruption prevalence.
Data were collected retrospectively from clinical notes and panoramic radiographs. Among the 11,924 radiographs, only the children who had at least one ectopically erupted PFM were included.
Measured: 6 months
Determination of the ectopic eruption related factors.
The angulation of PFM, mesialization ratio of PFM, and degree of adjacent PSM tooth root resorption were assessed using ImageJ application.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failure of Tooth Eruption Associated With Tooth ImpactionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seçil Çalışkan, Eskisehir Osmangazi University
- Investigators
- Seçil Çalışkan, Principal investigator, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282772
- Sponsor's protocol ID
- 2019/77-12
- Status last verified
- Feb 2020
- First submitted
- 21 Feb 2020
- Last updated
- 25 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ectopic Eruption of Permanent First Molars: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04282772
- Acronym / sponsor ID
- 2019/77-12
- Keywords
- Ectopic Eruption, Eruption Failure, Impacted Teeth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 25 Feb 2020 (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.
Ectopic eruption may be defined as the eruption of a permanent tooth that takes place in such a manner that a partial or a total resorption of the root(s) of an adjacent primary tooth occurs and can be noted during routine dental radiographic evaluation. It is a common case in mixed dentition and is usually diagnosed by a pediatric dentist. This retrospective study aimed to determine the prevalence and related factors of the ectopic eruption of permanent first molars(PFM). This retrospective study was performed using the panoramic radiographs of 11,924 child patients aged 6-10 years with at least one ectopically erupted PFM were included. The total prevalence of ectopic eruption, type, age, gender, jaw distribution, and bilateral versus unilateral occurrence were determined. The angulation of PFM, mesialization ratio of PFM, and degree of adjacent primary second molar(PSM) tooth root resorption were also assessed. The chi-square test, ANOVA was used for statistical analysis. A total of 76 ectopic eruptions were detected in the maxilla, 6 in the mandible, and 2 in both the maxilla and the mandible. In terms of the eruption status of cases with ectopic eruption, 27 were self-corrected, 51 remained impacted, and 6 were both. The impaction rate of the right upper PFMs was higher than that of others. No significant relationship was found between eruption status and degree of resorption. As a conclusion, small impaction of the PFM does not mean that the PSM lesion is also small. With substantial displacements, a proportionally diminutive lesion can exist, and vice versa.
Detailed description
Assessment of Angulation The angles between the axes of the PSMs and the long axes of the PFMs were measured. The angle was measured using ImageJ application (1.50 n, National Institutes of Health, Bethesda, MD, USA). The long axes were formed by a line extending parallel to the center of the tooth in an occluso-cervical manner. The vertical angle was defined as (-) or (+) according to Sun et al.The angles between the occlusal lines of the PSMs and the PFMs were measured. The horizontal angle was defined as (-) or (+) according to Sun et al.
Assessment of PSM Root Resorption The distal root resorption level of the PSM was determined using Barberia-Leache et al.'s classification2 as follows; Grade I: mild-limited resorption of the cementum or with minimum dentin penetration Grade II: moderate-resorption of the dentin without pulp exposition Grade III: severe-resorption of the distal root leading to pulp exposure Grade IV: very severe-resorption that affects the mesial root of the PSM.
Assessment of PFM Mesialization Ratio The mesiodistal size of the PFM and the amount of mesialization were measured by the Image J application to evaluate the differences between reversible and irreversible ectopic eruption. The mesiodistal size was measured from the largest part of the crown, and the amount of mesialization was measured using the distance between the drawn tangent on the distal wall of the PSM and the mesial convexity of the PFM. Afterwards, the amount of mesialization was proportioned to the mesiodistal size of the PFM.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ectopic Eruption | – | Diagnostic Test: Impacted, Diagnostic Test: Self-correctedThe ectopic eruption of PFMs were classified in two ways: impacted and self-corrected. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 11,924 child patients aged 6-10 years who attended the Pediatric Dentistry clinics at the Faculty of Dentistry, Eskisehir Osmangazi University, between March 2016 and March 2018.
Key inclusion criteria (1 listed)
- -Among the 11,924 radiographs, only the children who had at least one ectopically erupted PFM were included.
Key exclusion criteria (1 listed)
- -Presence of any history of extraction due to impaction, orthodontic treatment, or caries; the presence of any craniofacial anomalies, congenital deformities, or syndromes involving dental eruption; absent adjacent PSMs; and presence of any cyst, tumor, or other pathological condition in the molar area.
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 |
|---|---|---|
| ImpactedUntil an active treatment for the PFM is started or the early exfoliation of PSM occurs, the tooth remains in a self-locking position | Diagnostic test | Ectopic Eruption |
| Self-correctedThe ectopic erupted permanent molar can disregard the self-locking position and continue in a normal direction, but the distal root of the PSM remains more or less a significant atypical resorption | Diagnostic test | Ectopic Eruption |
Primary outcome
Determination of the ectopic eruption prevalence.
Time frame: 6 months
Data were collected retrospectively from clinical notes and panoramic radiographs. Among the 11,924 radiographs, only the children who had at least one ectopically erupted PFM were included.
Determination of the ectopic eruption related factors.
Time frame: 3 months
The angulation of PFM, mesialization ratio of PFM, and degree of adjacent PSM tooth root resorption were assessed using ImageJ application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Individual participant dataSharing planned: Undecided
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.
Seçil Çalışkan principal investigator
Eskişehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failure of Tooth Eruption Associated With Tooth Impaction, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Determination of the ectopic eruption prevalence. (time frame: 6 months). 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?
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 25 Feb 2020.