Endodontic DiseaseNCT04617301
Volumetric Analysis of Resorption Types on CBCT
An observational study of Endodontic Disease and Tooth Resorption, run by Recep Tayyip Erdogan University Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study. Read more about this study
- Who is it for?
- Ages 12 to 71 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease, Tooth Resorption
- How many people
- 43 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2020to 21 Oct 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 12 to 71 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Cases of resorption that had CBCT images were included in the study. Radiographic features of resorption were defined in the images of 34 patients in accordance with these criteria. A total of 43 teeth with ECR (n=27), ERR (n=4), and IRR (n=12) were identified from 34 patients.
Who may be able to join
- Cases of resorption that had CBCT images
Who cannot join
- those presenting pathologic lesions, congenital/developmental anomalies or teeth with root canal filling
- those whose CBCT scans failed to present satisfactory quality.
- Additionally, SR, TAP, and EIR cases were excluded because their true dimensions could not be completely determined before resorption.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Recep Tayyip Erdogan University Training and Research Hospital
Rize, 53100
About this study
Official title: Three-dimensional Volumetric/ Linear Analysis and Axial Classification of Root Resorptions Using Cone Beam Computed Tomography: A Retrospective Study
More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.
Read the detailed description
The aim of this study was to investigate the volumetric and linear analysis, and to present the axial classification of root resorptions using cone beam computed tomography (CBCT).
A total of 43 teeth of external cervical resorption (ECR) (n=27), external replacement resorption (ERR) (n=4) and internal root resorption (IRR) (n=12) were identified from 34 patients. The volume of resorption and total tooth, the widest lengths of these resorptions, and the amount of thinnest dentin thickness around them were measured and compared according to age and sex. Additionally, the eight regional axial classification was performed and the percentages in these regions were evaluated. Significance was set at p=0.05 for statistical analysis.
More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.
- Conditions
- Endodontic Disease, Tooth Resorption
- Keywords
- cone beam computed tomography, endodontics, tooth Resorption
- Medical subject headings
- Dental Pulp Diseases, Tooth Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1. Internal root resorption (IRR) | Internal root resorption is the progressive destruction of intraradicular dentin and dentinal tubules along the middle and apical thirds of the canal walls as a result of clastic activities. It is seen as a radiolucent area around the pulpal cavity, usually of incisors and mandibular molars. The various etiological factors suggested for internal root resorption include traumatic injury; infection and orthodontic treatment. | |
| Group 2. external cervical resorption (ECR) | Cementum is considered to protect the underlying root dentin from being resorbed. It is broadly accepted that damage to or deficiency of this protective cementum layer below the epithelial attachment exposes the root surface to osteoclasts, which then resorb the dentin. Clinical sign; Located in cervical region of tooth Pink spot might be noted by patient/dentist Tooth usually responds positively to vitality tests unless there is pulpal involvement (in very advanced cases) Spontaneous and profuse bleeding on probing Sharp, thinned out edges around the resorptive cavity | |
| Grup 3. external replacement resorption (ERR) | external replacement resorption also known as trauma-induced resorption - and this resorption may occur in teeth that also have external inflammatory resorption. This review will not discuss external replacement resorption in detail but it will be mentioned where relevant as both types of resorption may occur in some cases. This is because replacement resorption is a consequence of the same injuries that typically cause external inflammatory resorption - such as intrusion and avulsion where there is significant damage to the external root surface during the injury, as well as sometimes during the repositioning/ replantation of the tooth. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of total tooth and resorbed area
The total volume and the resorption volume were measured with used 3D semi-automatic segmentation program (ITK-SNAP 2.4)
Measured: for three months from the beginning of the study
Measurement widest mesio-distal length, bucco-lingual length and corono-apical length of the resorbed lesion
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
Measured: for three months from the beginning of the study
Linear measurements for thinnest dentin (buccal, distal, mesial and lingual/ palatinal) and resorbed area (mesio-distal length and bucco-lingual length) were made on axial sections
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
Measured: for three months from the beginning of the study
The corono-apical length was measured on sagittal sections where the tooth axis was perpendicular to the ground plane.
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
Measured: for three months from the beginning of the study
the axial section of the tooth was divided into eight parts and regional settlement classification was performed
Segmentation were made with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
Measured: for three months from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start22 Jun 2020
- Primary completion10 Aug 2020
- Study completion21 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Endodontic DiseaseStudies 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLARA NİL GÜNAÇAR, Recep Tayyip Erdogan University Training and Research Hospital
- Investigators
- Dilara Nil Günaçar, Study chair, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617301
- Sponsor's protocol ID
- 2020/98
- Status last verified
- Oct 2020
- First submitted
- 30 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heithersay GS. Clinical, radiologic, and histopathologic features of invasive cervical resorption. Quintessence Int. 1999 Jan;30(1):27-37.
PubMed 10323156Patel S, Dawood A, Wilson R, Horner K, Mannocci F. The detection and management of root resorption lesions using intraoral radiography and cone beam computed tomography - an in vivo investigation. Int Endod J. 2009 Sep;42(9):831-8. doi: 10.1111/j.1365-2591.2009.01592.x. Epub 2009 Jul 14.
PubMed 19627378
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Volumetric/ Linear Analysis and Axial Classification of Root Resorptions Using Cone Beam Computed Tomography: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04617301
- Acronym / sponsor ID
- 2020/98
- Conditions
- Endodontic Disease, Tooth Resorption
- Keywords
- cone beam computed tomography, endodontics, tooth Resorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 10 Aug 2020 (actual)
- Study completion
- 21 Oct 2020 (actual)
- First posted
- 5 Nov 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.
More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.
Detailed description
The aim of this study was to investigate the volumetric and linear analysis, and to present the axial classification of root resorptions using cone beam computed tomography (CBCT).
A total of 43 teeth of external cervical resorption (ECR) (n=27), external replacement resorption (ERR) (n=4) and internal root resorption (IRR) (n=12) were identified from 34 patients. The volume of resorption and total tooth, the widest lengths of these resorptions, and the amount of thinnest dentin thickness around them were measured and compared according to age and sex. Additionally, the eight regional axial classification was performed and the percentages in these regions were evaluated. Significance was set at p=0.05 for statistical analysis.
More accurate management of resorption can be achieved thanks to the three-dimensions volumetric and linear analysis, and the axial classification presented in this study.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1. Internal root resorption (IRR) | – | –Internal root resorption is the progressive destruction of intraradicular dentin and dentinal tubules along the middle and apical thirds of the canal walls as a result of clastic activities. It is seen as a radiolucent area around the pulpal cavity, usually of incisors and mandibular molars. The various etiological factors suggested for internal root resorption include traumatic injury; infection and orthodontic treatment. |
| Group 2. external cervical resorption (ECR) | – | –Cementum is considered to protect the underlying root dentin from being resorbed. It is broadly accepted that damage to or deficiency of this protective cementum layer below the epithelial attachment exposes the root surface to osteoclasts, which then resorb the dentin. Clinical sign; Located in cervical region of tooth Pink spot might be noted by patient/dentist Tooth usually responds positively to vitality tests unless there is pulpal involvement (in very advanced cases) Spontaneous and profuse bleeding on probing Sharp, thinned out edges around the resorptive cavity |
| Grup 3. external replacement resorption (ERR) | – | –external replacement resorption also known as trauma-induced resorption - and this resorption may occur in teeth that also have external inflammatory resorption. This review will not discuss external replacement resorption in detail but it will be mentioned where relevant as both types of resorption may occur in some cases. This is because replacement resorption is a consequence of the same injuries that typically cause external inflammatory resorption - such as intrusion and avulsion where there is significant damage to the external root surface during the injury, as well as sometimes during the repositioning/ replantation of the tooth. |
Who may qualify
- Ages
- 12 to 71 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cases of resorption that had CBCT images were included in the study. Radiographic features of resorption were defined in the images of 34 patients in accordance with these criteria. A total of 43 teeth with ECR (n=27), ERR (n=4), and IRR (n=12) were identified from 34 patients.
Key inclusion criteria (1 listed)
- Cases of resorption that had CBCT images
Key exclusion criteria (3 listed)
- those presenting pathologic lesions, congenital/developmental anomalies or teeth with root canal filling
- those whose CBCT scans failed to present satisfactory quality.
- Additionally, SR, TAP, and EIR cases were excluded because their true dimensions could not be completely determined before resorption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Volume of total tooth and resorbed area
Time frame: for three months from the beginning of the study
The total volume and the resorption volume were measured with used 3D semi-automatic segmentation program (ITK-SNAP 2.4)
Measurement widest mesio-distal length, bucco-lingual length and corono-apical length of the resorbed lesion
Time frame: for three months from the beginning of the study
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
Linear measurements for thinnest dentin (buccal, distal, mesial and lingual/ palatinal) and resorbed area (mesio-distal length and bucco-lingual length) were made on axial sections
Time frame: for three months from the beginning of the study
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
The corono-apical length was measured on sagittal sections where the tooth axis was perpendicular to the ground plane.
Time frame: for three months from the beginning of the study
Linear measurement were measured with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
the axial section of the tooth was divided into eight parts and regional settlement classification was performed
Time frame: for three months from the beginning of the study
Segmentation were made with used Planmeca ProMax 3D Classic (Planmeca Promax 3D; Planmeca Oy; Helsinki, Finland)
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 5 Nov 2020.
- Background: PubMed 10323156Heithersay GS. Clinical, radiologic, and histopathologic features of invasive cervical resorption. Quintessence Int. 1999 Jan;30(1):27-37.
- Background: PubMed 19627378Patel S, Dawood A, Wilson R, Horner K, Mannocci F. The detection and management of root resorption lesions using intraoral radiography and cone beam computed tomography - an in vivo investigation. Int Endod J. 2009 Sep;42(9):831-8. doi: 10.1111/j.1365-2591.2009.01592.x. Epub 2009 Jul 14.
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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.
Dilara Nil Günaçar study chair
Recep Tayyip Erdogan University Training and Research Hospital
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 Endodontic Disease and Tooth Resorption, run by Recep Tayyip Erdogan University Training and Research Hospital 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 3 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 5 Nov 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?
Volume of total tooth and resorbed area (time frame: for three months from the beginning of the study). The study lists 5 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 NCT04617301, which also lists 2 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 Nov 2020.