Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

Not Applicable

• Conditions: Root Canal Treatment; Endodontic Disease; Root Canal Infection
• Interventions: 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; Radiation: Radiographic imaging using periapical radiographs; Other: Disinfecting rubber dam; Other: The use of new instruments at time of obturation; Radiation: Cone Beam Computed Tomography scanning (CBCT)

• Registration Number: NCT03636087
• Lead Sponsor: King's College London

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.

Study Timeline

• Study First Submitted: 2018-08-13
• Study First Submitted QC: 2018-08-15
• Study First Posted: 2018-08-17
• Study Start: 2019-01-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-01
• Primary Completion: 2021-12-02
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Root canal obturation	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
Conventional	Coronal restoration build up	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
Conventional	Working Length Determination	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
Conventional	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 Cone Beam Computed Tomography scanning (CBCT) Radiographic imaging using periapical radiographs
Enhanced sterile protocol	Root canal obturation	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
Enhanced sterile protocol	Disinfecting rubber dam	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
Enhanced sterile protocol	Cone Beam Computed Tomography scanning (CBCT)	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
Conventional	Access cavity preparation	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
Enhanced sterile protocol	Access cavity preparation	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
Enhanced sterile protocol	Changing gloves before obturation	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
Enhanced sterile protocol	The use of new instruments at time of obturation	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
Conventional	Root canal instrumentation and chemo-mechanical preparation	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
Conventional	Cone Beam Computed Tomography scanning (CBCT)	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
Enhanced sterile protocol	Working Length Determination	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
Enhanced sterile protocol	Root canal instrumentation and chemo-mechanical preparation	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
Enhanced sterile protocol	Coronal restoration build up	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
Enhanced sterile protocol	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

Primary Outcome Measures

Name	Time	Method
Clinical healing of root canal treated teeth	one year follow up after treatment completion	Clinical examination of the soft tissue integrity around treated tooth(Absence of bumps, lumps or swelling)

Secondary Outcome Measures

Name	Time	Method
Radiographic healing of root canal treated teeth with periapical radiographs	one year follow up after treatment completion	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	one year follow up after treatment completion	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.

Trial Locations

Locations (1)

guy's Hospital; 🇬🇧 London, United Kingdom