Endodontic DiseaseNCT03636087
Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome
A study testing Access cavity preparation, Working Length Determination and Root canal instrumentation and chemo-mechanical preparation in people with Endodontic Disease and Root Canal Treatment, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Endodontic Disease, Root Canal Treatment, Root Canal Infection
- What is being tested?
- Access cavity preparation, Working Length Determination and Root canal instrumentation and chemo-mechanical preparation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Access cavity preparation, Working Length Determination, Root canal instrumentation and chemo-mechanical preparation, Root canal obturation, Coronal restoration build up
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access cavity preparationProcedure or surgery
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)
Working Length DeterminationProcedure or surgery
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)
Root canal instrumentation and chemo-mechanical preparationProcedure or surgery
Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
Root canal obturationProcedure or surgery
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)
Coronal restoration build upProcedure or surgery
A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
Changing gloves before obturationOther
The treating dentist will change gloves before obturation
Disinfecting rubber damOther
2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface
The use of new instruments at time of obturationOther
A new instrument's kit will be use at the time of obturation
Cone Beam Computed Tomography scanning (CBCT)Radiation
CBCT will be taken before treatment and one year after completion
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)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Access cavity preparation; Procedure: Working Length Determination; Procedure: Root canal instrumentation and chemo-mechanical preparation; Procedure: Root canal obturation; Procedure: Coronal restoration build up; Radiation: 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 Receives: Procedure: Access cavity preparation; Procedure: Working Length Determination; Procedure: Root canal instrumentation and chemo-mechanical preparation; Procedure: Root canal obturation; Procedure: Coronal restoration build up; Other: Changing gloves before obturation; Other: Disinfecting rubber dam; Other: The use of new instruments at time of obturation; Radiation: Cone Beam Computed Tomography scanning (CBCT); Radiation: Radiographic imaging using periapical radiographs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical healing of root canal treated teeth
Absence of symptoms reported by the patient.
Measured: one year follow up after treatment completion
Clinical healing of root canal treated teeth
Absence of pain with Percussion test.
Measured: one year follow up after treatment completion
Clinical healing of root canal treated teeth
Clinical examination to assess of the coronal filling.
Measured: 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)
Measured: one year follow up after treatment completion
Secondary outcomes (2)
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.
Measured: one year follow up after treatment completion
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.
Measured: one year follow up after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start1 Jan 2019
- Primary completion2 Dec 2021 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Francesco Mannocci, PhD, Principal investigator, Professor of Endodontology and 1st Academic Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636087
- Sponsor's protocol ID
- 242774
- Status last verified
- Aug 2021
- First submitted
- 13 Aug 2018
- Last updated
- 1 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome
- ClinicalTrials.gov ID
- NCT03636087
- Acronym / sponsor ID
- 242774
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- National Health Service, United Kingdom
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 2 Dec 2021 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Procedure: Access cavity preparation, Procedure: Working Length Determination, Procedure: Root canal instrumentation and chemo-mechanical preparation, Procedure: Root canal obturation, Procedure: Coronal restoration build up, Radiation: Cone Beam Computed Tomography scanning (CBCT), Radiation: Radiographic imaging using periapical radiographsAccess 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 |
| Enhanced sterile protocol | Experimental | Procedure: Access cavity preparation, Procedure: Working Length Determination, Procedure: Root canal instrumentation and chemo-mechanical preparation, Procedure: Root canal obturation, Procedure: Coronal restoration build up, Other: Changing gloves before obturation, Other: Disinfecting rubber dam, Other: The use of new instruments at time of obturation, Radiation: Cone Beam Computed Tomography scanning (CBCT), Radiation: Radiographic imaging using periapical radiographsAccess 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Access cavity preparationHigh 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) | Procedure or surgery | Conventional, Enhanced sterile protocol |
| Working Length DeterminationThe 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) | Procedure or surgery | Conventional, Enhanced sterile protocol |
| Root canal instrumentation and chemo-mechanical preparationRotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol) | Procedure or surgery | Conventional, Enhanced sterile protocol |
| Root canal obturationGutta 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) | Procedure or surgery | Conventional, Enhanced sterile protocol |
| Coronal restoration build upA Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol) | Procedure or surgery | Conventional, Enhanced sterile protocol |
| Changing gloves before obturationThe treating dentist will change gloves before obturation | Other | Enhanced sterile protocol |
| Disinfecting rubber dam2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface | Other | Enhanced sterile protocol |
| The use of new instruments at time of obturationA new instrument's kit will be use at the time of obturation | Other | Enhanced sterile protocol |
| Cone Beam Computed Tomography scanning (CBCT)CBCT will be taken before treatment and one year after completion | Radiation | Conventional, Enhanced sterile protocol |
| Radiographic imaging using periapical radiographsPeriapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol) | Radiation | Conventional, Enhanced sterile protocol |
Primary outcome
Clinical healing of root canal treated teeth
Time frame: one year follow up after treatment completion
Absence of symptoms reported by the patient.
Clinical healing of root canal treated teeth
Time frame: one year follow up after treatment completion
Absence of pain with Percussion test.
Clinical healing of root canal treated teeth
Time frame: one year follow up after treatment completion
Clinical examination to assess of the coronal filling.
Clinical healing of root canal treated teeth
Time frame: one year follow up after treatment completion
Clinical examination of the soft tissue integrity around treated tooth(Absence of bumps, lumps or swelling)
2 secondary outcomes
Radiographic healing of root canal treated teeth with periapical radiographs
Time frame: one year follow up after treatment completion
Radiographic healing of root canal treated teeth with Cone Beam Computed Tompgraphy
Time frame: one year follow up after treatment completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2021.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Mannocci, PhD principal investigator
Professor of Endodontology and 1st Academic Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access cavity preparation, Working Length Determination and Root canal instrumentation and chemo-mechanical preparation in people with Endodontic Disease and Root Canal Treatment, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical healing of root canal treated teeth (time frame: one year follow up after treatment completion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2021.