Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

Endodontic Disease Clinical Trial

Official title:

Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03636087
• Other study ID #: 242774
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: September 1, 2022

Study information

• Verified date: August 2021
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 176
• Est. completion date: September 1, 2022
• Est. primary completion date: December 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Root Canal Infection
• Root Canal Treatment

Intervention

Procedure:
• 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)

Other:
• 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

Radiation:
• 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)

Locations

Country	Name	City	State
United Kingdom	guy's Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	National Health Service, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical healing of root canal treated teeth	Absence of symptoms reported by the patient.	one year follow up after treatment completion
Primary	Clinical healing of root canal treated teeth	Absence of pain with Percussion test.	one year follow up after treatment completion
Primary	Clinical healing of root canal treated teeth	Clinical examination to assess of the coronal filling.	one year follow up after treatment completion
Primary	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	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.	one year follow up after treatment completion
Secondary	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.	one year follow up after treatment completion