Comparison of outcomes of single- versus multiple-visit in endodontically treated anterior and premolar teeth, using Cone-beam Computed Tomography
Design
A randomized, double-blinded, phase III clinical trial outcome assessment
Settings and conduct
This study will be conducted at Dept. of Endodontics, Shahid Beheshti Dental School. Patients meeting the inclusion criteria will be randomly assigned to two groups after filling a written informed consent. CBCT image of the region of interest would be taken before any interventions. A similar standard treatment protocol will be performed in both groups, other than the placement of intra-canal calcium hydroxide in the two-visit group.
The coronal restoration will be placed no later than one week. After one year another CBCT image will be taken and the reduction in periapical lesion volume will be measured and analyzed.
The statistician and two calibrated clinicians who analyze the CBCT images will be blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
All patients with at least one maxillary/mandibular, anterior/premolar tooth with mature apex and no previous root canal therapy
Necrotic pulp confirmed by cold and electric pulp tests
Detectable periapical radiolucency in the periapical radiograph and the largest diameter within 2-5 millimeters
Teeth without periodontal disease
Sufficient coronal structure for proper isolation and direct restoration
No history of antibiotic intake for the past one month
Exclusion criteria:
All patients with current or a history of systemic diseases interfering with tissue healing (diabetes mellitus, under radiotherapy, on bisphosphonates, immunocompromised)
Intervention groups
Intervention: Two-visit root canal treatment using calcium hydroxide as intra-canal medicament
Control: Single-visit root canal treatment
Main outcome variables
Reduction in the volume of periapical lesions
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190331043142N1
Registration date:2019-04-18, 1398/01/29
Registration timing:registered_while_recruiting
Last update:2019-04-18, 1398/01/29
Update count:0
Registration date
2019-04-18, 1398/01/29
Registrant information
Name
Mandana Naseri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2205 6675
Email address
m.naseri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-08, 1398/02/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcomes of single- versus multiple-visit in endodontically treated anterior and premolar teeth, using Cone-beam Computed Tomography
Public title
Effect of the number of treatment visits on the outcome of root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with at least one maxillary/mandibular, anterior/premolar tooth with mature apex and no previous root canal therapy
Necrotic pulp confirmed by cold and electric pulp tests
Detectable periapical radiolucency in the periapical radiograph and the largest diameter of the periapical radiolucency within 2-5 millimeters
Teeth without periodontal disease
Sufficient coronal structure for proper isolation and direct restoration
No history of antibiotic intake for the past one month
Exclusion criteria:
All patients with current or a history of systemic diseases interfering with tissue healing (diabetes mellitus, patients under radiotherapy, use of bisphosphonates, immunocompromised patients)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Restricted randomization and specifically random allocation rule was utilized in order to make the sample size in both groups equal. The whole sample size had been determined in advance (n=30) and was divided equally between two groups. Fifteen cards coded 1 and 15 others cards coded 2 were placed in an opaque bowl. A person blinded to the study picked a card from this bowl for each patient.
Blinding (investigator's opinion)
Double blinded
Blinding description
The clinician could not be blinded to the procedure.
Two calibrated clinicians other than the practitioner who performed the procedure would further analyze the size of the lesion in CBCT images.
The statistician will be also blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Velenjak St., Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2019-01-30, 1397/11/10
Ethics committee reference number
IR.SBMU.DRC.REC.1397.069
Health conditions studied
1
Description of health condition studied
Chronic apical periodontitis
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis of pulpal origin
2
Description of health condition studied
Periapical abscess with sinus tract
ICD-10 code
K04.6
ICD-10 code description
Periapical abscess with sinus
3
Description of health condition studied
Periapical abscess without sinus
ICD-10 code
K04.7
ICD-10 code description
Periapical abscess without sinus
Primary outcomes
1
Description
The volume of periapical lesions
Timepoint
Baseline, 1 year follow up
Method of measurement
Measurement of the volume of the lesion using Cone-beam Computed Tomography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Using calcium hydroxide as intra-canal medicament for 1 week and performing the root canal therapy in two visits.
Category
Treatment - Drugs
2
Description
Control group: Performing the root canal treatment in a single visit with no calcium hydroxide dressing
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dept. of Endodontics, Dental School, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mandana Naseri
Street address
Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2217 5350
Email
m.naseri@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
6th floor, Shahid Beheshti University of Medical Sciences, Arabi Ave., Daneshjoo Blvd., Yemen St., Shahid Chamran Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2387 2203
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mandana Naseri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dept. of Endodontics, Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 268 5384
Email
mandana.nasseri@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mandana Naseri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dept. of Endodontics, Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 912 268 5384
Email
mandana.nasseri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Atefeh Gohari
Position
Postgraduate student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dept. of Endodontics, Dental School, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 4464 8321
Email
atp.gohari@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Currently, we cannot publish individual patient data because of the need for further studies and analyses.