NCT06027931

Brief Summary

Aims of the study:

  1. 1.Assess the clinical and radiographical outcomes (success/failure) of root canal treatments performed after traditional vs conservative access cavities in permanent posterior teeth after one-year follow-up.
  2. 2.Assess the level of disinfection in root canals accessed by traditional vs conservative access cavities in permanent posterior teeth before obturation.

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
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 12, 2024

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

March 28, 2023

Last Update Submit

September 7, 2023

Conditions

Root Canal InfectionRoot Canal Treatment

Keywords

Root Canal,CFU

Outcome Measures

Primary Outcomes (1)

  • The absence of clinical signs and symptoms in participants.

    (pain, tenderness to percussion, sinus tract, swelling).

    1 year

Study Arms (2)

Conservative Access Opening

EXPERIMENTAL

Root canal treatment using Conservative Access Opening type.

Procedure: Conservative Access Opening, Traditional Access Opening

Traditional Access Opening

EXPERIMENTAL

Root canal treatment using Traditional Access Opening type.

Procedure: Conservative Access Opening, Traditional Access Opening

Interventions

Conservative Access Opening, Traditional Access OpeningPROCEDURE

Conservative Access Opening will be used and evaluated for cleaning ability versus Traditional Access Opening.

Conservative Access OpeningTraditional Access Opening

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of root canal disease.
  • Must be able to undergo endodontic treatment.

You may not qualify if:

  • pregnancy patients.
  • patients received radiotherapy.
  • patient age over 70 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Private Dental Center

Baghdad, 00964, Iraq

Location

Study Officials

  • Ahmed H Ali, Ph.D

    University of Baghdad

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 28, 2023

First Posted

September 7, 2023

Study Start

September 12, 2022

Primary Completion

May 12, 2024

Study Completion

May 12, 2024

Last Updated

September 13, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

CBCTs

Locations

IR(1)