NCT06146894

Brief Summary

The goal of this prospective clinical randomized study is to evaluate the effect of different obturation techniques on postobturation pain in single-visit root canal treatment in 18-60 years old patient who present no systemic disease (American Society of Anesthesiology class I or II) and require nonsurgical root canal treatment The main question it aims to answer which obturation technique used with bioceramic sealer cause less postobturation pain in single-visit root canal treatment in comparison to AH plus sealer used with lateral condensation or warm vertical compaction. Participants will receive single visit root canal treatment using bioceramic sealer with different obturation techniques Group 1: Single cone technique Group 2: lateral condensation technique Group 3: Vertical compaction technique to see effect of different obturation technique on postobturation pain in single-visit root canal treatment.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 27, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2024

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

6 months

First QC Date

November 17, 2023

Last Update Submit

June 5, 2024

Conditions

Postoperative Pain

Keywords

Postoperative PainBioceramic sealerObturation

Outcome Measures

Primary Outcomes (1)

  • postobturation pain

    Presence of post-obturation pain will accessed by visual analog scale (VAS) scale (0-10), where 0 showed no pain, 1-3 mild pain, 4-6 moderate pain, 7-9 severe pain, and 10 worst possible pain.

    30 days

Study Arms (5)

Single cone technique (Bioceramic Sealer)

EXPERIMENTAL
Procedure: Single obturation technique (Bioceramic Sealer)

lateral condensation technique (Bioceramic Sealer)

EXPERIMENTAL
Procedure: lateral condensation technique (Bioceramic Sealer)

Warm Vertical condensation technique (Bioceramic Sealer)

EXPERIMENTAL
Procedure: Warm Vertical condensation technique (Bioceramic Sealer)

lateral condensation technique (AH plus Sealer)

EXPERIMENTAL
Procedure: lateral condensation technique (AH Plus Sealer)

Warm Vertical condensation technique (AH plus Sealer)

EXPERIMENTAL
Procedure: Warm Vertical condensation technique (AH plus Sealer)

Interventions

Single obturation technique (Bioceramic Sealer)PROCEDURE

Root canal will be obturated using single cone technique using Bioceramic Sealer

Single cone technique (Bioceramic Sealer)
lateral condensation technique (Bioceramic Sealer)PROCEDURE

Root canal will be obturated using lateral condensation technique using Bioceramic Sealer

lateral condensation technique (Bioceramic Sealer)
Warm Vertical condensation technique (Bioceramic Sealer)PROCEDURE

Root canal will be obturated using vertical condensation technique using Bioceramic Sealer

Warm Vertical condensation technique (Bioceramic Sealer)
lateral condensation technique (AH Plus Sealer)PROCEDURE

Root canal will be obturated using lateral condensation technique using AH plus Sealer

lateral condensation technique (AH plus Sealer)
Warm Vertical condensation technique (AH plus Sealer)PROCEDURE

Root canal will be obturated using vertical condensation technique using AH plus Sealer

Warm Vertical condensation technique (AH plus Sealer)

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-60 years who presented no systemic disease (American Society of Anesthesiology class I or II) and required nonsurgical root canal treatment.
  • Diagnosis of asymptomatic irreversible pulpitis in a molar tooth with 3 independent root canals.

You may not qualify if:

  • Presence of immature root apexes, root fracture, or periodontal disease
  • Use of any analgesic, anti- inflammatory, or antibiotics before the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

kafrelsheikh University

Kafr ash Shaykh, Kafr El-Shaikh, 33511, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Pain, PostoperativeBites and Stings

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPoisoningChemically-Induced DisordersWounds and Injuries

Study Officials

  • Hisham Abada, PhD

    Kafrelsheikh University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hisham Abada, PhD

CONTACT

01003772427Hisham.dentist@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

November 17, 2023

First Posted

November 27, 2023

Study Start

December 1, 2023

Primary Completion

June 10, 2024

Study Completion

June 28, 2024

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

EG(1)