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Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

Primary Purpose

Endodontic Disease, Root Canal Treatment, Root Canal Infection

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
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
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • guy's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional

Enhanced sterile protocol

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical healing of root canal treated teeth
Absence of symptoms reported by the patient.
Clinical healing of root canal treated teeth
Absence of pain with Percussion test.
Clinical healing of root canal treated teeth
Clinical examination to assess of the coronal filling.
Clinical healing of root canal treated teeth
Clinical examination of the soft tissue integrity around treated tooth(Absence of bumps, lumps or swelling)

Secondary Outcome Measures

Radiographic healing of root canal treated teeth with periapical radiographs
Healing of the bony area around the root tip assessed by the absence or change in the size of radiolucincies (Darkness) in the x-rays.
Radiographic healing of root canal treated teeth with Cone Beam Computed Tompgraphy
Healing of the bony area around the root tip assessed by the absence or change in the size of radiolucincies (Darkness) in the x-rays.

Full Information

First Posted
August 13, 2018
Last Updated
August 31, 2021
Sponsor
King's College London
Collaborators
National Health Service, United Kingdom
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1. Study Identification

Unique Protocol Identification Number
NCT03636087
Brief Title
Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome
Official Title
Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 2, 2021 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
National Health Service, United Kingdom

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Patients will be randomized to either group 1 or 2.Randomization by blocks will be performed by a statistician at Kings College Dental Institute. Group 1 will receive a conventional root canal therapy. While in group 2,clinician will follow sterile protocol. This will be carried out at KCL Dental Institute at Guy's Hospital as a part of the routine dental treatment at the endodontic postgraduate unit. Potential participants will be given a written information sheet and sufficient time to consider participation. Fully informed written consent will be obtained if they are interested in participation. After providing consent, all participants will receive dental periapical (PA) radiograph and Cone Beam Computed Tomography (CBCT) scans which are part of standard care in root canal treatment. Then, a clinical assessment will be carried out for the tooth needing treatment which is routinely done before treatment. Participants will then be randomly assigned to one of treatment groups. Treatment will be carried out by MclinDent postgraduate students (PG) supervised by their assigned clinical supervisor. It is a standard of care for PG students to undertake this type of treatment. During the treatment, clinical samples will be taken from tooth decay and from the root canal. These samples will undergo microbiological analysis by the research team. After one year, all patients will be contacted for follow up appointment. Paired clinical and radiographic examination (PA and CBCT) will be carried out, matching the baseline measures. Healing will be evaluated radiographically and clinically. The tooth of interest will be examined for any pain or discomfort, the restoration will be evaluated, and the scans will be checked for radiographic healing. This follow up procedure is a standard of care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endodontic Disease, Root Canal Treatment, Root Canal Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
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
Arm Title
Enhanced sterile protocol
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Access cavity preparation
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Working Length Determination
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Root canal instrumentation and chemo-mechanical preparation
Intervention Description
Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
Intervention Type
Procedure
Intervention Name(s)
Root canal obturation
Intervention Description
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)
Intervention Type
Procedure
Intervention Name(s)
Coronal restoration build up
Intervention Description
A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
Intervention Type
Other
Intervention Name(s)
Changing gloves before obturation
Intervention Description
The treating dentist will change gloves before obturation
Intervention Type
Other
Intervention Name(s)
Disinfecting rubber dam
Intervention Description
2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface
Intervention Type
Other
Intervention Name(s)
The use of new instruments at time of obturation
Intervention Description
A new instrument's kit will be use at the time of obturation
Intervention Type
Radiation
Intervention Name(s)
Cone Beam Computed Tomography scanning (CBCT)
Intervention Description
CBCT will be taken before treatment and one year after completion
Intervention Type
Radiation
Intervention Name(s)
Radiographic imaging using periapical radiographs
Intervention Description
Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)
Primary Outcome Measure Information:
Title
Clinical healing of root canal treated teeth
Description
Absence of symptoms reported by the patient.
Time Frame
one year follow up after treatment completion
Title
Clinical healing of root canal treated teeth
Description
Absence of pain with Percussion test.
Time Frame
one year follow up after treatment completion
Title
Clinical healing of root canal treated teeth
Description
Clinical examination to assess of the coronal filling.
Time Frame
one year follow up after treatment completion
Title
Clinical healing of root canal treated teeth
Description
Clinical examination of the soft tissue integrity around treated tooth(Absence of bumps, lumps or swelling)
Time Frame
one year follow up after treatment completion
Secondary Outcome Measure Information:
Title
Radiographic healing of root canal treated teeth with periapical radiographs
Description
Healing of the bony area around the root tip assessed by the absence or change in the size of radiolucincies (Darkness) in the x-rays.
Time Frame
one year follow up after treatment completion
Title
Radiographic healing of root canal treated teeth with Cone Beam Computed Tompgraphy
Description
Healing of the bony area around the root tip assessed by the absence or change in the size of radiolucincies (Darkness) in the x-rays.
Time Frame
one year follow up after treatment completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Mannocci, PhD
Organizational Affiliation
Professor of Endodontology and 1st Academic Supervisor
Official's Role
Principal Investigator
Facility Information:
Facility Name
guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.

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Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

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