The effect of AH26 and Resil resin sealers on postoperative pain after endodontic treatment in patient with irreversible pulpitis: A randomized controlled clinical trial study
• Post-treatment pain after AH26 and Resil sealer and comparison of patients' pain levels with AH26 sealer and Resil sealer.
• Analgesics consumption after endodontic treatment with AH26 and Resil sealer.
• Comparison of analgesics consumption after endodontic treatment with AH26 sealer and Resil sealer.
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized by stratified permuted block randomization method, phase 3 per 100 patients
Settings and conduct
Patients will be selected from those referred to the endodontics department of Shahid Beheshti Dental School who have first or second mandibular molars with irreversible pulpitis. Participants were divided into two groups based on the type of sealer used and the pulp condition: 1) irreversible pulp/sealer AH26 2) irreversible pulp / Resil sealer and 50 patients will be examined in each group. It is a double-blind controlled randomized trial. Patients are randomly assigned to the modified block randomization method.
Participants/Inclusion and exclusion criteria
Individuals who have molars with irreversible pulpitis will be selected. Patients with healthy periapical tissue and without allergic sensitivity to the materials and drugs used during endodontic treatment are included in the study. Patients who need emergency treatment or have taken painkillers and antibiotics during the last seven days with more than 4 mm probing depth are excluded from the study.
Intervention groups
The AH26 resin sealer is placed in the canals for obturation in the first group.
The Resil resin sealer is placed in the canals for obturation in the second group.
Main outcome variables
Number of pain after root canal treatment; Number of analgesic consumption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150720023253N5
Registration date:2022-05-10, 1401/02/20
Registration timing:registered_while_recruiting
Last update:2022-05-10, 1401/02/20
Update count:0
Registration date
2022-05-10, 1401/02/20
Registrant information
Name
Nazanin Zargar
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 3075
Email address
n.zargar48@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-10, 1401/02/20
Expected recruitment end date
2022-06-10, 1401/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of AH26 and Resil resin sealers on postoperative pain after endodontic treatment in patient with irreversible pulpitis: A randomized controlled clinical trial study
Public title
The effect of AH26 and Resil sealers on pain after endodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years
Patients who do not have systemic problems and immunosuppression and are not treated with medication.
Patients who are not allergic to the medicines used during endodontic treatment and local anesthetics.
Patients with a long-term positive pulp response to the cold test and EPT (moderate to severe responses (vas = 40-100)) or long and delayed responses.
Patients diagnosed with irreversible pulpitis in the first or second mandibular molars.
Patients with healthy periapical tissue (confirmed by radiography and clinic)
Exclusion criteria:
Symptomatic teeth that need emergency endodontic treatment.
Teeth that have been treated in two sessions.
Patients who have been taking analgesics or antibiotics for the past seven days.
Patients with periodontal disease (probe depths greater than 4 mm).
Teeth with open apex, apical resorption, or canal calcification.
Patients who have multiple teeth in need of endodontic treatment.
Teeth that have been treated with crown.
Patients taking antibiotics after treatment for any reason.
Patients with allergies to nonsteroidal anti-inflammatory drugs
Patients who are pregnant or breastfeeding.
Overfilling treatments (gutta-percha or sealer extrusion beyond radiographic apex).
Under filing treatments (more than 2 mm shorter than radiographic apex).
Teeth with severe crown destruction need core build-up crowns.
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The permuted block randomization method randomly divides 100 patients into two groups.
Eighteen blocks, each with four subjects, are assumed. The statistician generates the random sequence for each block using the Excel software (Microsoft Corporation, Redmond, WA, USA). Following the random sequence, a nurse places the sealer and VAS diagrams into similar opaque bags labeled for each block and opens only after chemo-mechanical preparation and before the obturation. The investigator is unaware of the coding details.
Blinding (investigator's opinion)
Double blinded
Blinding description
A research assistant not involved in the treatment performs allocation by random permuted block and stratification by gender. Computer-generated randomized patient codes concealed in opaque envelopes are revealed just before obturation. The envelopes are opened by an assistant not involved in the research, but only when the endodontic sealer is going to be inserted into the root canal. Patients are randomized for the endodontic sealer used (AH26, Resil). Each patient can contribute a maximum of two teeth only when they are on opposite sides of the mouth. Patients are blinded to the treatment allocation, and clinicians are also blinded to the treatment allocation up to obturation. The operator knows which sealer will be used right before filling the root canal. The patients are blinded to the sealer.
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, School of Dentistry
Street address
Shahid Beheshti University of Medical Sciences., Daneshjou Blvd., Velenjak., Tehran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2021-12-26, 1400/10/05
Ethics committee reference number
IR.SBMU.DRC.REC.1400.088
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Number of pain after root canal treatment
Timepoint
6,12,24,48 hours after treatment and 3,4,5,6 and 7 days after treatment
Method of measurement
visual analog scale
2
Description
Dosage of analgesics consumption
Timepoint
6,12,24,48 hours after treatment and 3,4,5,6 and 7 days after treatment
Method of measurement
Number of medicaments taken
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After canal preparation and selecting the gutta-percha cone, the AH26 resin sealer is placed in the canals for obturation.
Category
Treatment - Drugs
2
Description
Intervention group: After canal preparation and selecting the gutta-percha cone, the Resil resin sealer is placed in the canals for obturation.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences, School of Dentistry