NCT04617301

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 22, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2020

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

2 months

First QC Date

October 30, 2020

Last Update Submit

October 30, 2020

Conditions

Keywords

cone beam computed tomographyendodonticstooth Resorption

Outcome Measures

Primary Outcomes (5)

  • 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)

    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)

    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)

    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)

    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)

    for three months from the beginning of the study

Study Arms (3)

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.

Eligibility Criteria

Age12 Years - 71 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • Cases of resorption that had CBCT images

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Recep Tayyip Erdogan University Training and Research Hospital

Rize, 53100, Turkey (Türkiye)

Location

Related Publications (2)

  • Heithersay GS. Clinical, radiologic, and histopathologic features of invasive cervical resorption. Quintessence Int. 1999 Jan;30(1):27-37.

    PMID: 10323156BACKGROUND
  • Patel 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.

    PMID: 19627378BACKGROUND

MeSH Terms

Conditions

Dental Pulp DiseasesTooth Resorption

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Dilara Nil Günaçar

    Recep Tayyip Erdogan University Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 5, 2020

Study Start

June 22, 2020

Primary Completion

August 10, 2020

Study Completion

October 21, 2020

Last Updated

November 5, 2020

Record last verified: 2020-10

Locations