evaluating pain and flare-up after treatment following the use of NeoPUTTY as an apical plug in mandibular first molar teeth
Design
The study is conducted as a single-center double-arm trial. Thirty patients will be divided into two equal groups (15 patients each).
Settings and conduct
Department of Endodontics, Faculty of Dentistry, Mashhad
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients in the age range of 6 to 15 years
• Necrotic immature mandibular first molar with open apex (size 60 to 100)
• A tooth with chronic apical periodontitis with a radiolucency greater than 3 mm2 in periapical radiography.
• A tooth without tract sinus, no drainage from the canal, no swelling and no acute apical periodontitis
• Patients should not have pain in the desired tooth area before starting the treatment
• Patients have not received any medicine before starting the treatment
Non-entry criteria:
• Teeth with root fractures, resorption or calcifications
• Non-cooperative child
• Teeth with damaged periodontal structure, severe mobility
Intervention groups
Shaping and cleaning of the tooth root canal is done using Protaper rotary file system up to number F3. Irrigation 2.5% sodium hypochlorite using a 27-gauge side vent needle and activation with the sonic Endoactivator device.
In the first group, OrthoMTA and in the second group, NEOPUTTY will be prepared, it will be taken into the canal using System MAP One and will be condensed into a 3-5 mm thick plug at the apical end of the root canal.
Then, in both groups, the canal will be temporarily restored using cavit, and the second session 24 hours later, canal obturation will be performed using warm vertical compression technique with AH 26 sealer. Three, 6, 12, 24, 48 and 72 hours after root canal treatment, the patient's pain and swelling are evaluated according to VAS criteria.
Main outcome variables
Pain; swelling; flare-up
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240607062028N1
Registration date:2024-08-28, 1403/06/07
Registration timing:prospective
Last update:2024-08-28, 1403/06/07
Update count:0
Registration date
2024-08-28, 1403/06/07
Registrant information
Name
Maryam Khorasanchi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 611 9705
Email address
khorasanchim4011@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-11-05, 1403/08/15
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of NeoPUTTY as an apical plug used in mandibular first molar in postoperative pain and flare up; a randomized clinical trial
Public title
Evaluating the effect of NeoPUTTY as an apical plug used in 6th tooth of lower jaw in postoperative pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 6 to 15 years
Necrotic immature mandibular first molar with open apex (size 60 to 100)
A tooth with chronic apical periodontitis with the presence of a radiolucency greater than 3 mm2 in periapical radiography
Tooth without sinus tract, no drainage from the canal, no swelling and no acute apical periodontitis
Patients should not have pain in the area of the target tooth before starting the root canal treatment
Patients should have not received any medical treatment before starting the root canal treatment
Teeth without root deviation, root resorption or calcification
Tooth without previous root canal treatment or crown
Teeth without any root fracture or craze lines
Exclusion criteria:
Necrotic immature mandibular first molar with open apex (larger than size 100)
Teeth with root fracture, craze lines, root deviation, resorption or calcifications
lack of child cooperation
Teeth with compromised periodontal structure, severe mobility
Teeth with previous root canal treatment, post or crown
Teeth with open apex and severe destruction that are unrestorable
Patient unwillingness to participate
Major systemic disease (ASA 3 or higher)
The patient's severe pain that led to the use of analgesic
Age
From 6 years old to 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are entered into the study according to the inclusion criteria and are randomly assigned to one of the two study groups using double blocks and tap/line (coin toss). In order to ensure an equal number of intervention and control group samples in each of the mesial and distal root subgroups, first, the sample in odd sequences is assigned to the intervention or control group in the form of tap/line, and in even sequences as The reverse is done with the odd sequence of allocation. If there is a need to put a plug in both roots of the first molar of the mandible, first one of the roots is selected as a tap/line and the other root will be in the same group as the first root.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the participants, the evaluators for the follow-up of the patient's pain, and the statistical data analysts will not know about the study groups.
Only the operator who performs the treatment process of the patients will be aware of the participants' grouping after the allocation and immediately before the treatment.
As for the patients blinding, the preparation of the substance will be done away from the patient's sight.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Dentistry - Mashhad University of Medical Sciences (Ethics Committee)
Street address
Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Approval date
2024-03-09, 1402/12/19
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1403.019
Health conditions studied
1
Description of health condition studied
Flare-up and pain
ICD-10 code
K04.5
ICD-10 code description
Chronic apical periodontitis
Primary outcomes
1
Description
Flare-up and pain
Timepoint
3, 6, 12, 24, 48 and 72 hours postoperative
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: NeoPUTTY (Avalon Biomed Inc., Bradenton, USA). A bioceramic, bioactive MTA is premixed in a syringe. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet cotton. According to the manufacturer's brochure, the setting time of this material is 4 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). At the end of this session, a periapical radiograph is prepared to ensure the thickness of the placed plug. The next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and rubber dam isolation, temporary dressing and wet cotton balls are removed. . The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each.
Category
Treatment - Other
2
Description
Control group: OrthoMTA (BioMTA, Seoul, Korea). An MTA is a powder that needs to be mixed with normal saline to achieve a sandy/creamy consistency. This material is placed at the apical end of the roots as a plug by MAP One (Produits Dentaires S. A., Vevey, Switzerland). Using a suitable plugger, it will be compacted in the form of a plug to reach a thickness of 3-5 mm at the apical end of the root canal. After the MTA has solidified, the excess MTA on the canal wall is gently wiped off with wet paper point. According to the manufacturer's brochure, the setting time of this material is 3 hours. Therefore, a wet paper point will be placed on it and the canal is temporarily dressed with Cavit (3M ESPE, Seefeld, Germany). A periapical radiograph is prepared at the end of this session to ensure the thickness of the plug. In the next session, after 24 hours, if there is no pain and symptoms, under local anesthesia and isolation of Ruberdem, the temporary dressing and wet cotton balls are removed. The MTA setting is slowly checked with a #40k file. Obturation of the canal will be done by the hot vertical compression technique with AH 26 sealer, and the patient's root canal treatment will be completed. In total, 2 treatment sessions will take about 90 minutes each
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad School of Dentistry
Full name of responsible person
Maryam Gharechahi
Street address
School of dentistry, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٧٧٩۴٨٩۵٩
Phone
+98 51 3882 9510
Email
khorasanchim4011@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Research and Technology Vice-Chancellor, Qurashi Building, next to Hoizeh Cinema, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khorasanchi
Position
Endodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No43, South Khayyam1, Khayyam Blv.
City
Mashhad
Province
Razavi Khorasan
Postal code
9185714715
Phone
+98 915 119 9667
Email
khorasanchim4011@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Gharechahi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Endodontics Department, Mashhad School of Dentistry, University Campus, Azadi Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
gharechahim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Khorasanchi
Position
Endodontics Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Azadi Square, University campus, Faculty of Dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 933 611 9705
Fax
Email
khorasanchim4011@mums.ac.ir
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
No more info is 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only part of the data, such as the information related to the main outcome, can be shared.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Researchers working in academic and scientific institutions and people who are also engaged in industry
Under which criteria data/document could be used
Just for study and not for analysis
From where data/document is obtainable
Maryam Khorasanchi
Khorasanchim4011@mums.ac.ir
What processes are involved for a request to access data/document
After receiving the request email, it will take about 2 to 4 weeks