NCT03636087

Brief Summary

The main goal of root canal treatment is the removal of existing microorganisms and the prevention of introducing new ones to the root canal system. This will require the application of strict aseptic measures. Microorganisms may also find their way into the root canal system through dental materials and instruments that are used during the treatment. Some studies have suggested the necessity of decontamination of these materials and instruments prior to using. Also, the practice of changing gloves and disinfecting the tooth and rubber dam may help to reduce the possibility of introducing bacteria into the root canal space. This study is aimed to evaluate the success rate of initial root canal treatment using an enhanced sterility protocol.

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
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

August 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 1, 2021

Status Verified

August 1, 2021

Enrollment Period

2.9 years

First QC Date

August 13, 2018

Last Update Submit

August 31, 2021

Conditions

Endodontic DiseaseRoot Canal TreatmentRoot Canal Infection

Outcome Measures

Primary Outcomes (4)

  • Clinical healing of root canal treated teeth

    Absence of symptoms reported by the patient.

    one year follow up after treatment completion

  • Clinical healing of root canal treated teeth

    Absence of pain with Percussion test.

    one year follow up after treatment completion

  • Clinical healing of root canal treated teeth

    Clinical examination to assess of the coronal filling.

    one year follow up after treatment completion

  • Clinical healing of root canal treated teeth

    Clinical examination of the soft tissue integrity around treated tooth(Absence of bumps, lumps or swelling)

    one year follow up after treatment completion

Secondary Outcomes (2)

  • Radiographic healing of root canal treated teeth with periapical radiographs

    one year follow up after treatment completion

  • Radiographic healing of root canal treated teeth with Cone Beam Computed Tompgraphy

    one year follow up after treatment completion

Study Arms (2)

Conventional

ACTIVE COMPARATOR

Access cavity preparation Working length determination Root canal instrumentation and chemo-mechanical preparation Root canal obturation Coronal restoration build up Cone Beam Computed Tomography scanning (CBCT) Radiographic imaging using periapical radiographs

Procedure: Access cavity preparationProcedure: Working Length DeterminationProcedure: Root canal instrumentation and chemo-mechanical preparationProcedure: Root canal obturationProcedure: Coronal restoration build upRadiation: Cone Beam Computed Tomography scanning (CBCT)Radiation: Radiographic imaging using periapical radiographs

Enhanced sterile protocol

EXPERIMENTAL

Access cavity preparation Working length determination Root canal instrumentation and chemo-mechanical preparation Root canal obturation Coronal restoration build up Changing gloves before obturation Disinfecting rubber dam The use of new instruments at time of obturation Cone Beam Computed Tomography scanning (CBCT) Radiographic imaging using periapical radiographs

Procedure: Access cavity preparationProcedure: Working Length DeterminationProcedure: Root canal instrumentation and chemo-mechanical preparationProcedure: Root canal obturationProcedure: Coronal restoration build upOther: Changing gloves before obturationOther: Disinfecting rubber damOther: The use of new instruments at time of obturationRadiation: Cone Beam Computed Tomography scanning (CBCT)Radiation: Radiographic imaging using periapical radiographs

Interventions

Access cavity preparationPROCEDURE

High speed handpieces will be used with access burs to open the pulp chamber and get access to the root canal system (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol
Working Length DeterminationPROCEDURE

The length of the root canal will be measured using periodical radiographs and Electronic Apex Locators (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol
Root canal instrumentation and chemo-mechanical preparationPROCEDURE

Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol
Root canal obturationPROCEDURE

Gutta Percha filling materials will be used to fill the root canal space with root canal sealer (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol
Coronal restoration build upPROCEDURE

A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol
Changing gloves before obturationOTHER

The treating dentist will change gloves before obturation

Enhanced sterile protocol
Disinfecting rubber damOTHER

2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface

Enhanced sterile protocol
The use of new instruments at time of obturationOTHER

A new instrument's kit will be use at the time of obturation

Enhanced sterile protocol
Cone Beam Computed Tomography scanning (CBCT)RADIATION

CBCT will be taken before treatment and one year after completion

ConventionalEnhanced sterile protocol
Radiographic imaging using periapical radiographsRADIATION

Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)

ConventionalEnhanced sterile protocol

Eligibility Criteria

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

You may qualify if:

  • Patients seeking root canal treatment over 18 years old.
  • Healthy patients.
  • Diagnosed with Irreversible pulpitis or pulpal necrosis on any molar tooth and accepting root canal treatment.

You may not qualify if:

  • Patients with clinical and radiographic diagnosis of previously treated root canal.
  • Anterior or premolar teeth.
  • Evidence of external or internal root resorption.
  • Pregnant women.
  • Patients younger than 18.
  • Patients unable to give consent.
  • Patients with compromised medical condition that affect the outcome of root canal therapy.
  • Non-restorable teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

guy's Hospital

London, SE1 9RT, United Kingdom

Location

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Root Canal PreparationRoot Canal Obturation

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Root Canal TherapyEndodonticsDentistryTooth Preparation

Study Officials

  • Francesco Mannocci, PhD

    Professor of Endodontology and 1st Academic Supervisor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study is single blind since the patient will not be aware of what technique is being used. The study cannot be double blind because the dentist will need to identify the protocol to follow. Randomization by blocks (block size 4) will be performed by a statistician at Kings College Dental Institute.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2018

First Posted

August 17, 2018

Study Start

January 1, 2019

Primary Completion

December 2, 2021

Study Completion

September 1, 2022

Last Updated

September 1, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Consented patients will be allocated an a pseudo anonymized number. This number will be used for the sample collection and all study analysis. The Principal Investigator will maintain a document database of all patient's allocation numbers. Personal data, clinical notes and treatment records will be recorded in SALUD software as part of routine dental treatment at Guy's hospital. Only the chief investigator and supervisors will have access to the participants' allocation numbers and thus treatment records in SALUD during the study.

Locations

GB(1)