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Clinical Trials/NCT05841290
NCT05841290
Recruiting
N/A

The Incidence of Postoperative Pain After Using Different Types of Sealers (A Randomized Clinical Trial)

British University In Egypt1 site in 1 country50 target enrollmentAugust 1, 2022

Overview

Phase
N/A
Intervention
Primary local anesthesia
Conditions
Post Operative Pain
Sponsor
British University In Egypt
Enrollment
50
Locations
1
Primary Endpoint
Postoperative pain
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of this randomized clinical trial is to evaluate and compare the incidence and intensity of post-operative pain after obturation using resin and silicon-based sealers.

Detailed Description

The main objectives of root canal therapy are to achieve long-term comfort, function, and aesthetics for the patients and prevention of reinfection of tooth. These objectives are provided through complete cleaning, shaping, and obturation of canals of affected teeth . Some patients may report moderate-to-severe pain and/or swelling following root canal treatment . This is detrimental for both patient and dentist and may entail an unscheduled emergency visit by patients to relieve their symptoms. Postoperative pain is considered a clinical outcome that exhibits the multifactorial nature of patients' responses to variables among treatment procedures such as maintaining the working length to the apical constriction, finishing the endodontic treatment in single visit or multiple visit, instrumentation technique and the type of endodontic sealer used for obturation . Such pain occurrence is mainly due to mechanical, chemical or microbial injury to the periapical tissues . Trauma of periapical tissue or bacterial extrusion and root canal sealer specifically, extrusion of root canal sealer can disrupt periodontal tissues and cause inflammatory reactions. The intensity of this reaction depends on the composition of the sealer . Root canal sealers can play a crucial role in this regard by coming in contact with the periapical tissues through apical foramen and lateral canals causing a localized inflammation with a direct influence on the degree of inflammation based on the composition of the sealer in turn influencing postoperative pain levels . Silicone is inert and biocompatible and has been widely used in medicine as an implant material Silicone-based root-canal sealers are also available. However, there are no data on the clinical performance of this type of material in endodontic treatment .

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
October 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kareem darwish

Teaching Assistant, Endodontics department , Faculty of dentistry brititsh university in egypt

British University In Egypt

Eligibility Criteria

Inclusion Criteria

  • • Patient's age ranges from 18-50 years old.
  • Patients with teeth diagnosed with symptomatic irreversible pulpitis.
  • Normal periapical condition confirmed by normal periapical radiograph
  • The teeth are restorable
  • Teeth are periodontally free, with no mobility and negative to percussion and palpation test.

Exclusion Criteria

  • • Teeth with immature roots
  • Non restorable teeth
  • Medically compromised patients with systemic complication that would alter the treatment.
  • Necrotic teeth
  • Teeth with apical periodontitis or periapical lesions
  • necrotic Teeth.

Arms & Interventions

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Primary local anesthesia

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Supplemental local anesthesia

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Removal Of Caries and Access Cavity

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Rubber dam isolation of tooth

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Bleeding control

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Canal negotiation

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Coronal flaring

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Working Length Determination (W.L)

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Glide path

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Irrigation

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Cleaning and shaping using rotary system

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Second w.l determination

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Apical gauging

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Activation of the irrigant

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Master cone check

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: application of resin based sealer inside the canal in the resin based sealer group

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: application of the sillicon based sealer inside the canal in the sillicon based group

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Obturation

Group (1) Resin Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.

Intervention: Visual Analogue Scale (VAS)

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Primary local anesthesia

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Supplemental local anesthesia

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Removal Of Caries and Access Cavity

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Rubber dam isolation of tooth

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Bleeding control

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Canal negotiation

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Coronal flaring

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Working Length Determination (W.L)

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Glide path

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Irrigation

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Cleaning and shaping using rotary system

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Second w.l determination

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Apical gauging

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Activation of the irrigant

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Master cone check

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: application of resin based sealer inside the canal in the resin based sealer group

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: application of the sillicon based sealer inside the canal in the sillicon based group

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Obturation

Group (2) Silicone Based Sealer intervention

evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Intervention: Visual Analogue Scale (VAS)

Outcomes

Primary Outcomes

Postoperative pain

Time Frame: after 72 hours of endodontic treatment

Pain is evaluated using visual analogue scale (VAS) which is a pain rating scale. Scores are based on measures that are self-reported of symptoms that are recorded through a single handwritten mark placed at one point along the length of a 10-cm line representing a continuum between the two ends of the scale; on the left end of the scale (0 cm) means "no pain" and the on the right end of the scale (10 cm) "worst pain"

Study Sites (1)

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