Protocol summary

Study aim
Assessment of pain intensity following endodontic retreatment of asymptomatic mandibular molars with Gutta-Percha, Mineral Trioxide Aggregate, and Cold Ceramic
Design
An interventional, single-blind, randomized, parallel, phase 2/3 clinical trial on 60 patients
Settings and conduct
All procedures will be performed by an endodontist at the Endodontic Clinic, Kurdistan University of Medical Sciences. After local anesthesia and isolation, canal access will be established and prepared with M3-Pro Gold rotary files, with working length determined using an apex locator (Root ZX) and radiographs. Apical patency will be ensured with a #10 K-file. Patients will be assigned to three groups: A: Obturation with Gutta-percha using the cold lateral compaction technique B: Obturation with Mineral Trioxide Aggregate (MTA) (Angelus, Brazil), Apical as an MTA plug and coronal by the backfill method C: Obturation with Cold Ceramic (Samin, Iran), Apical as a plug and coronal using the backfill method Pain intensity will be recorded at 8, 24, 48, and 72 hours using the Visual Analog Scale (VAS)
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with at least one mandibular molar requiring retreatment, with asymptomatic teeth and periapical radiographic lesions, and systemically healthy, will be included in the study Exclusion Criteria: Patients with uncontrolled systemic diseases, pregnant women, and those with acute periapical infections causing swelling and abscess will be excluded from the study
Intervention groups
Group A : Gutta-percha using cold lateral compaction Group B: Mineral Trioxide Aggregate, apical plug and coronal backfill Group C: Cold Ceramic, apical plug and coronal backfill
Main outcome variables
Pain intensity after retreatment of mandibular molars obturated with three root canal filling materials: Gutta-percha, Mineral Trioxide Aggregate, and Cold Ceramic

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251003067492N1
Registration date: 2025-10-12, 1404/07/20
Registration timing: prospective

Last update: 2025-10-12, 1404/07/20
Update count: 0
Registration date
2025-10-12, 1404/07/20
Registrant information
Name
Erfan Ahmadyani
Name of organization / entity
Kurdisan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 937 938 6232
Email address
edrisg2001@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-11-16, 1404/08/25
Expected recruitment end date
2025-12-16, 1404/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of postoperative pain intensity after retreatment of mandibular molar teeth obturated with gutta-percha, Mineral Trioxide Aggregate (MTA), and Cold Ceramic
Public title
Comparison of pain intensity following endodontic retreatment of mandibular molars with Gutta-Percha, Mineral Trioxide Aggregate (MTA), and Cold Ceramic: A randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with asymptomatic mandibular molars requiring endodontic retreatment. Presence of periapical radiolucency on the target tooth. Patients aged over 18 years and under 60 years. Patients able and willing to provide informed consent.
Exclusion criteria:
Presence of uncontrolled systemic diseases. Presence of non-odontogenic or chronic pain.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The study will be conducted in three treatment groups, as detailed below: 1. Group A : Root canal obturation with Gutta-Percha using Cold Lateral Compaction (CLC) technique. 2. Group B: Root canal obturation with MTA (Angelus, Brazil): the apical one-third is filled with an MTA plug, and the coronal two-thirds are filled using the Backfill technique. 3. Group C: Root canal obturation with Cold Ceramic (Samin, Iran), First, the apical plug is placed, followed by the coronal backfill. • Randomization in this study will be performed using the block randomization method to allocate participants into groups. The final sample size will include 60 participants. The blocks consist of three units and are arranged in a combination of A, B, and C. The final number of blocks is six, and their sequence is as follows: 1. ABC 2. ACB 3. BAC 4. BCA 5. CBA 6. CAB To select the blocks, a random number table is used. In this method, we start from the first number in the table and move from left to right. Whenever a number between 1 and 6 appears, the corresponding block is selected, and numbers outside this range are ignored.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will not be aware of the type of canal filling material used.
Placebo
Not used
Assignment
Parallel
Other design features
This is a randomized, single-blind, parallel, interventional clinical trial, phase 2/3, conducted on 60 patients.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Ave, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713491
Approval date
2025-09-30, 1404/07/08
Ethics committee reference number
IR.MUK.REC.1404.193

Health conditions studied

1

Description of health condition studied
Postoperative pain after retreatment of mandibular molar teeth
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Pain intensity after retreatment of mandibular molars obturated with three root canal filling materials: Gutta-percha, Mineral Trioxide Aggregate, and Cold Ceramic.
Timepoint
8, 24, 48, and 72 hours after treatment.
Method of measurement
Visual Analog Scale (VAS) questionnaire.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Obturation with Gutta-Percha using Cold Lateral Compaction (CLC).
Category
N/A

2

Description
Intervention group: Obturation with Mineral Trioxide Aggregate (MTA) (Angelus, Brazil): the apical one-third is filled with an MTA plug, and the coronal two-thirds are filled using Backfill.
Category
N/A

3

Description
Intervention group: Obturation with Cold Ceramic (Samin, Iran): an apical plug is placed followed by coronal Backfill
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences Dental Clinic
Full name of responsible person
Erfan Ahmadyani
Street address
Pasdaran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713491
Phone
+98 937 938 6232
Email
Edrisg2001@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Fardin Fathi
Street address
Pasdaran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 937 938 6232
Email
Edrisg2001@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Erfan Ahmadyani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713491
Phone
+98 937 938 6232
Email
Ahmadyanierfan1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Erfan Ahmadyani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713491
Phone
+98 937 938 6232
Email
Ahmadyanierfan1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Erfan Ahmadyani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran, Kurdistan University of Medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713491
Phone
+98 937 938 6232
Email
Ahmadyanierfan1@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after de-identification of individual participants.
When the data will become available and for how long
Access will begin after the publication of the results.
To whom data/document is available
Researchers affiliated with academic and scientific institutions
Under which criteria data/document could be used
Researchers will have access to the data under any circumstances.
From where data/document is obtainable
For further information, you can contact the corresponding author via the following email: [ahmadyanierfan1@gmail.com]
What processes are involved for a request to access data/document
After sending a request via email to the corresponding author, the requester will have unlimited access to the data.
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