Impact of an Enhanced Sterile Protocol on Root Canal Treatment Outcome

NCT03636087 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2021-09-01

No results posted yet for this study

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.

Conditions

  • Endodontic Disease
  • Root Canal Treatment
  • Root Canal Infection

Interventions

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)

PROCEDURE

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)

PROCEDURE

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)

PROCEDURE

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)

PROCEDURE

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

OTHER

Disinfecting rubber dam

2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface

OTHER

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

RADIATION

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)

Sponsors & Collaborators

Principal Investigators

  • Francesco Mannocci, PhD · Professor of Endodontology and 1st Academic Supervisor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-02
Completion
2022-09-01

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03636087 on ClinicalTrials.gov