NCT06013293

Brief Summary

The goal of root canal therapy is thorough disinfection and obturation of the root canal system in all its dimensions and promote periradicular tissue repair.This study was done to compare the postopertaive pain after single visit endodontics using resin based sealer and zinc oxide eugeonal sealer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 28, 2023

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2023

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

August 28, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

August 22, 2023

Last Update Submit

August 22, 2023

Conditions

Post Operative Pain

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    . Postoperative Visual analogue pain scores will be recorded

    immediately after the procedure

Study Arms (2)

Zinc oxide eugenol based sealer

EXPERIMENTAL

Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and zinc oxide eugenol sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.

Procedure: Zinc oxide eugeonal based sealer

Resin based sealer

ACTIVE COMPARATOR

Root canal treatment will be performed in posterior teeth.In this group the root canal will be dried with paper points and obturated with using gutta-percha cones and resin based sealer. Coronal access cavities will be restored with direct composite restorations using dentinal adhesives and universal composite resin . Postoperative VAS scores will be recorded after 24 h and 48 h to determine their post-operative pain.

Procedure: Resin Based Sealer

Interventions

Zinc oxide eugeonal based sealerPROCEDURE

Zinc oxide-eugenol (ZOE)- based preparations, which have been used in root canal obturation (RCO) for over a hundered years and are known for their antimicrobial activities.slight microleakage and zinc oxide-eugenol's superior antibacterial property,slight microleakage and concerning the lower cytotoxicity, the zinc oxide-eugenol (ZOE) sealer can be used for root canal obturation as an endodontic sealer.After root canal prepartion , the root canal will be dried with paper points and obturated using gutta-percha cones and zinc oxide eugenol sealer.

Zinc oxide eugenol based sealer
Resin Based SealerPROCEDURE

resin-based sealer used frequently as a gold standard for endodontic sealers, due to its good physicochemical properties and provide satisfactory adhesion interface with dentin radicular surface.After root canal preparation, the root canal will be dried with paper points and obturated using gutta-percha cones and Resin based sealer

Resin based sealer

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who agree to participate in study
  • ASA CLASSIFICATION 1or 2
  • Minimum age of 18years old and maximum age of 65 years old
  • Maxillary and Mandibular single rooted teeth included in the study
  • Patient with symptomatic irreversible pulpitis with either normal apical tissue or symptomatic apical periodontitis.

You may not qualify if:

  • \- 1. ASA Classification 3 to 5 2. Patient with immature apices and root resorption will be excluded from the study.
  • \. Severe periodontal problem. 4. Vertical or horizontal root fractures will be excluded from the study 5. Patients who will be already on analgesia within 24 hours excluded from study 6. Those requiring root canal treatment of two or more teeth ipsilaterally (since the pain caused by any of these teeth can result in false positive reading) will be excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry

Islamabad, 0920, Pakistan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

epoxy resin-based root canal sealer

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Ahsen Amin, BDS

CONTACT

03315161642ahsen_amin@hotmail.com

Aqsa Waheed, BDs

CONTACT

03063422518q.aqsa@rocketmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 22, 2023

First Posted

August 28, 2023

Study Start

October 1, 2022

Primary Completion

August 30, 2023

Study Completion

September 1, 2023

Last Updated

August 28, 2023

Record last verified: 2023-08

Locations

PA(1)