NCT03171376

Brief Summary

Increased incidence of apical periodontitis was reported where root filling was found coronal to the marginal bone due to communication between pulp and periodontal space. It has been suggested to place intraorifice barrier in the canal to provide coronal seal. However there exists a void in literature regarding clinical validity of the termination of obturation apical to marginal bone and placement of intraorifice barrier in resolution of periapical pathology. Therefore this randomized controlled trial intends to investigate effect of coronal level of obturation on endodontic success and marginal breakdown.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2016

Status
completed

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 14, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
Last Updated

May 24, 2018

Status Verified

September 1, 2017

Enrollment Period

1.1 years

First QC Date

May 24, 2017

Last Update Submit

May 22, 2018

Conditions

Apical Periodontitis

Keywords

Root canal treatmentCoronal leakageIntraorifice barrier

Outcome Measures

Primary Outcomes (2)

  • Clinical success

    Success was defined as absence of signs and symptoms and reduction in pocket depth measured in millimeter.

    Baseline to one year.

  • Radiographic Success

    Absence of periapical alterations (radiolucency at furcal or periapical region).

    Baseline to one year

Study Arms (3)

Intraorifice Group

ACTIVE COMPARATOR

After root canal treatment intraorifice barrier of glass-ionomer cement (Ketac™ Molar, 3M ESPE ) placed 3mm inside canals from root canal orifice.

Procedure: Root canal treatment and coronal restoration

Base Group

ACTIVE COMPARATOR

2mm thick base of glass-ionomer cement (Ketac™ Molar, 3M ESPE ) applied uniformly on the floor of the pulp chamber after completion root canal treatment.

Procedure: Root canal treatment and coronal restoration

Control Group

ACTIVE COMPARATOR

Neither intraorifice barrier nor base applied after completion of root canal treatment.

Procedure: Root canal treatment and coronal restoration

Interventions

Root canal treatment and coronal restorationPROCEDURE

After primary root canal treatment, Glass Ionomer Cement (Ketac™ Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.

Base GroupControl GroupIntraorifice Group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mature permanent mandibular molars.
  • Pulpal necrosis as confirmed by negative response to pulp sensibility test (cold and electric pulp test) ;
  • Radiographic evidence of apical periodontitis in the form of periapical radiolucency (size not more than 2 × 2 mm);
  • Generalized chronic periodontitis criteria will be considered when ≥ 30% of sites will be involved with clinical attachment loss (CAL) slight = 1or 2mm, Moderate = 3-4mm, and severe ≥ 5mm.
  • Probing depth\<4mm
  • Radiographic alveolar bone breakdown not more than one third of root length.

You may not qualify if:

  • Younger than 18 years;
  • Pregnant, diabetic, or immunocompromised;
  • Having a positive history of antibiotic use within the past month or require antibiotic premedication for dental treatment (including infective endocarditis or prosthetic joint prophylaxis);
  • Teeth having previous root fillings, unrestorable teeth, fractured/perforated roots, grade 3 mobility, and history of recent periodontal therapy (within previous 6 months); and
  • Teeth with established endodontic-periodontal lesions exhibiting \<2 mm radiopaque bone between the root apex.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

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
SPONSOR

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 31, 2017

Study Start

October 14, 2016

Primary Completion

November 15, 2017

Study Completion

November 15, 2017

Last Updated

May 24, 2018

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share