NCT05808062

Brief Summary

The goal of this clinical trial is to evaluate root canal obturation quality. The questions to answer are

  • what is the best protocol for canal dryness before obturation ?
  • Is compaction necessary ? Volunteer participants will perform root canal treatment in teeth planned for extraction due to orthodontic reasons

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 11, 2023

Completed
Last Updated

August 3, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

March 29, 2023

Last Update Submit

August 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • obturation quality

    percentage of voids within the filling by micro CT analysis

    after 30 days

Study Arms (2)

Total dryness

ACTIVE COMPARATOR

matching paper points are used till they come out completely dry

Procedure: Root canal obturation

Partial dryness

ACTIVE COMPARATOR

a single matching cone is inserted in the canal for 3 seconds only.

Procedure: Root canal obturation

Interventions

Root canal dryness

Partial drynessTotal dryness

Eligibility Criteria

Age23 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males and females (Category: American Society of Anesthesiologists class 1)
  • aged 23-25 years
  • presenting with sound maxillary premolars (non-carious and not previously restored)
  • a radiographically visible root canal outline

You may not qualify if:

  • dental students of any level were not eligible to avoid including vulnerability factors.
  • pregnant volunteers
  • volunteers with complicating systemic disease (ASA 3-6)
  • poor oral hygiene
  • periodontal disease (probing depth \>3 mm) related to the tooth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, The British University in Egypt

Cairo, El-Sherouk, 11837, Egypt

Location

Related Publications (2)

  • Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.

  • Nawar NN, Elashiry MM, El Banna A, Saber SM, Schafer E. Ex-vivo evaluation of clinically-set hydraulic sealers used with different canal dryness protocols and obturation techniques: a randomized clinical trial. Clin Oral Investig. 2024 Oct 27;28(11):612. doi: 10.1007/s00784-024-06006-5.

MeSH Terms

Conditions

Bites and Stings

Interventions

Root Canal Obturation

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersWounds and Injuries

Intervention Hierarchy (Ancestors)

Root Canal TherapyEndodonticsDentistry

Study Officials

  • Shehabeldin Saber, phD

    Faculty of Dentistry, The British University in Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pofessor

Study Record Dates

First Submitted

March 29, 2023

First Posted

April 11, 2023

Study Start

January 1, 2022

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

August 3, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after study completion
Access Criteria
PI email

Locations