The Incidence of Postoperative Pain After Using Different Types of Sealers

Not Applicable

Recruiting

• Conditions: Root Canal Sealers; Sillicon Based Sealers; Resin Based Sealers; Post Operative Pain
• Interventions: Procedure: Primary local anesthesia; Procedure: Supplemental local anesthesia; Procedure: Removal Of Caries and Access Cavity; Procedure: Rubber dam isolation of tooth; Procedure: Bleeding control; Procedure: Canal negotiation; Procedure: Coronal flaring; Procedure: Working Length Determination (W.L); Procedure: Glide path; Procedure: Irrigation; Procedure: Cleaning and shaping using rotary system; Procedure: Second w.l determination; Procedure: Apical gauging; Procedure: Activation of the irrigant; Procedure: Master cone check; Drug: application of resin based sealer inside the canal in the resin based sealer group; Diagnostic Test: application of the sillicon based sealer inside the canal in the sillicon based group; Procedure: Obturation; Diagnostic Test: Visual Analogue Scale (VAS)

• Registration Number: NCT05841290
• Lead Sponsor: British University In Egypt

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 .

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2023-04-22
• Study First Posted: 2023-05-03
• Status Verified: 2024-07
• Primary Completion: 2024-07
• Last Update Submitted: 2024-07-05
• Last Update Posted: 2024-07-08
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group (1) Resin Based Sealer intervention	Rubber dam isolation of tooth	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Primary local anesthesia	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Bleeding control	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Canal negotiation	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Coronal flaring	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Supplemental local anesthesia	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Removal Of Caries and Access Cavity	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Working Length Determination (W.L)	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Glide path	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Irrigation	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Cleaning and shaping using rotary system	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Second w.l determination	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Apical gauging	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Activation of the irrigant	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Master cone check	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	application of resin based sealer inside the canal in the resin based sealer group	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	application of the sillicon based sealer inside the canal in the sillicon based group	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Obturation	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (1) Resin Based Sealer intervention	Visual Analogue Scale (VAS)	evaluate the incidence and intensity of post-operative pain after obturation using resin based sealers.
Group (2) Silicone Based Sealer intervention	Rubber dam isolation of tooth	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Bleeding control	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Canal negotiation	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Coronal flaring	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Primary local anesthesia	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Supplemental local anesthesia	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Removal Of Caries and Access Cavity	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Working Length Determination (W.L)	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Glide path	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Irrigation	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Cleaning and shaping using rotary system	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Second w.l determination	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Apical gauging	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Activation of the irrigant	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Master cone check	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	application of resin based sealer inside the canal in the resin based sealer group	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	application of the sillicon based sealer inside the canal in the sillicon based group	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Obturation	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.
Group (2) Silicone Based Sealer intervention	Visual Analogue Scale (VAS)	evaluate the incidence and intensity of post-operative pain after obturation using sillicon based sealers.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	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"

Trial Locations

Locations (1)

British University in Egypt; 🇪🇬 El Shorouk, Cairo, Egypt