Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome
NCT ID: NCT03636087
Last Updated: 2021-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
176 participants
INTERVENTIONAL
2019-01-01
2022-09-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional
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
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 Determination
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 preparation
Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
Root canal obturation
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 up
A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
Cone Beam Computed Tomography scanning (CBCT)
CBCT will be taken before treatment and one year after completion
Radiographic imaging using periapical radiographs
Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)
Enhanced sterile protocol
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
Access cavity preparation
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 Determination
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 preparation
Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
Root canal obturation
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 up
A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
Changing gloves before obturation
The treating dentist will change gloves before obturation
Disinfecting rubber dam
2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface
The use of new instruments at time of obturation
A new instrument's kit will be use at the time of obturation
Cone Beam Computed Tomography scanning (CBCT)
CBCT will be taken before treatment and one year after completion
Radiographic imaging using periapical radiographs
Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)
Interventions
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Access cavity preparation
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 Determination
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 preparation
Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
Root canal obturation
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 up
A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
Changing gloves before obturation
The treating dentist will change gloves before obturation
Disinfecting rubber dam
2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface
The use of new instruments at time of obturation
A new instrument's kit will be use at the time of obturation
Cone Beam Computed Tomography scanning (CBCT)
CBCT will be taken before treatment and one year after completion
Radiographic imaging using periapical radiographs
Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)
Eligibility Criteria
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Inclusion Criteria
2. Healthy patients.
3. Diagnosed with Irreversible pulpitis or pulpal necrosis on any molar tooth and accepting root canal treatment.
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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National Health Service, United Kingdom
OTHER_GOV
King's College London
OTHER
Responsible Party
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Principal Investigators
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Francesco Mannocci, PhD
Role: PRINCIPAL_INVESTIGATOR
Professor of Endodontology and 1st Academic Supervisor
Locations
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guy's Hospital
London, , United Kingdom
Countries
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Other Identifiers
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242774
Identifier Type: -
Identifier Source: org_study_id
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