NCT04249206

Brief Summary

The objective of the study is to evaluate and compare, clinically and radiographically, the outcome of non surgical primary/secondary root canal treatment using a hydraulic sealer or a zinc oxide-eugenol sealer.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2016

Longer than P75 for phase_4

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

May 1, 2016

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

5.6 years

First QC Date

January 28, 2020

Last Update Submit

January 29, 2020

Conditions

Apical Periodontitis

Keywords

root canal obturationhydraulic sealersingle coneendodontic outcome

Outcome Measures

Primary Outcomes (1)

  • Periapical Healing

    Clinical and radiographic evidence of the absence of apical periodontitis or healing of each tooth (PAI score \<2)

    4 year

Secondary Outcomes (1)

  • tooth survival

    4 year

Study Arms (2)

Hydraulic Sealer Group

EXPERIMENTAL

The single-cone obturation technique is based on a master cone of gutta-percha in conjunction with a hydraulic sealer. Hydraulic endodontic cements exhibit excellent hydraulic properties, biocompatibility and bioactivity.

Procedure: Root Canal Treatment

Zinc oxide-eugenol Sealer Group

ACTIVE COMPARATOR

The continuous wave of condensation of gutta-percha and a zinc oxide-eugenol (ZOE) sealer is a gold standard in endodontic obturation.

Procedure: Root Canal Treatment

Interventions

Root Canal TreatmentPROCEDURE
Hydraulic Sealer GroupZinc oxide-eugenol Sealer Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • a permanent, single or multi-rooted mature tooth
  • clinical diagnosis of irreversible pulpitis
  • diagnosis of apical periodontitis

You may not qualify if:

  • subjects with immune-compromised status
  • subjects with an overall poor prognosis for their treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bardini G, Casula L, Ambu E, Musu D, Mercade M, Cotti E. A 12-month follow-up of primary and secondary root canal treatment in teeth obturated with a hydraulic sealer. Clin Oral Investig. 2021 May;25(5):2757-2764. doi: 10.1007/s00784-020-03590-0. Epub 2020 Sep 28.

    PMID: 32989597DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2020

First Posted

January 30, 2020

Study Start

May 1, 2016

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

January 30, 2020

Record last verified: 2020-01