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Root Canal InfectionNCT03719404

Irrigants on Outcome of Non Surgical Endodontic Retreatment

A study testing sodium hypochlorite and chlorhexidine in people with Root Canal Infection, run by Postgraduate Institute of Dental Sciences Rohtak.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Till date, no study has systematically evaluated the role of a single variable on success of endodontic retreatment. While the evaluation of a single factor as the primary objective in a study is a difficult task, it unarguably provides more valuable information regarding the influence of that variable on outcome. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Root Canal Infection
What is being tested?
sodium hypochlorite and chlorhexidine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
103 participants
Where
No sites listed yet
Study dates
Oct 2016to Apr 2018
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previously root filled Permanent teeth with post-treatment apical periodontitis requiring nonsurgical root canal retreatment with clinical symptoms like pain on palpation and discomfort to percussion
  • Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
  • previous initial endodontic treatment was done atleast 4 years before.
  • Patient's age more than 18 years.
  • Patient willingness to participate in the study

Who cannot join

  • periodontal deep pockets more than 4mm, previous procedural errors, not suitable for rubber dam isolation, vertical root fractures, intraradicular post, marginal or furcal bone loss due to periodontitis, nonrestorable teeth and patients with diabetes, pregnancy, antibiotic medication within last three months, any systemic or immunocompromising conditions.

About this study

Official title: Effect of Irrigants on Outcome of Non Surgical Endodontic Retreatment: A Randomised Controlled Trial

Till date, no study has systematically evaluated the role of a single variable on success of endodontic retreatment. While the evaluation of a single factor as the primary objective in a study is a difficult task, it unarguably provides more valuable information regarding the influence of that variable on outcome. The clinical studies comparing the use of Sodium hypochlorite (NaOCl) and Chlorhexidine digluconate (CHX) in retreatment cases have evaluated only the antibacterial effectiveness and there is no clinical study comparing their effect on the clinical outcome in retreatment cases. And also, no study has compared the use of irrigant as single variable in the primary objective on success of retreatment cases. The conclusions drawn from such "surrogate measures" must be interpreted and applied in clinical settings with caution. Since there is no standardised irrigation treatment protocol for secondary root canal treatment, the present study is being conducted to evaluate the effect of 5% NaOCl with 17% Ethylenediaminetetraacetic acid (EDTA) and 2% CHX with 10% citric acid (CA) on outcome, when used as irrigants during the chemomechanical preparation in retreatment cases.

Read the detailed description

Introduction: Retreatment is defined as a procedure to remove root canal filling materials from the tooth, followed by cleaning, shaping and obturating the canals (AAE glossary of endodontic terms). There is a scarcity in retreatment studies when compared to literature available pertaining to primary root canal treatment. Till date, only 7 studies are available which have attempted to analyse the factors predicting the prognosis of nonsurgical retreatment. However, none of these studies has systematically evaluated the role of a single variable on success of endodontic retreatment. These are either retrospective or cohort studies, with no study identifiable as a randomised controlled trial. While the evaluation of a single factor as the primary objective in a study is a difficult task, it unarguably provides more valuable information regarding the influence of that variable on outcome. The present study is being conducted to evaluate the effect of 5% NaOCl with 17% EDTA, and 2% CHX with 10% CA on outcome, when used as irrigants during the chemomechanical preparation in retreatment cases.

Aim and Objectives: To evaluate and compare the success of nonsurgical endodontic retreatment following use of the two different irrigant regimes, using 5% NaOCl with 17% EDTA and 2% CHX with 10% CA.

Setting: Study subjects will be recruited from Post Graduate Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana.

Study design: Prospective randomized controlled trial Time frame: 18 months Method: Patients with above inclusion criteria will be selected and randomly allocated to one of the two study groups according to the irrigants used ( NaOCl + EDTA , CHX + CA ). The secondary root canal treatment was completed in two visits. Proper rubber dam isolation and aseptic conditions were followed throughout the procedure. Caries and /or coronal restorations were removed with sterile burs. The coronal two thirds of the root filling was mechanically removed with hand files. A sterile #15 K- file was used to create space by applying a gentle filing motion. A larger endodontic file was used to engage the root canal filling material and the file with the attached root filling material was withdrawn from the canal. The working length was determined with the aid of the electronic apex locator and radiographs using digital sensor (Carestream RVG 5200, Carestream Health Inc, Rochester, NY). Apical preparation was completed to the working length with hand stainless-steel files. 2 ml of corresponding chosen primary irrigant (NaOCl or CHX) was used after each instrument change in the respective groups. All the irrigation procedures were performed using a 30 gauge needle ensuring that the needle was placed to within 1-2mm from the apex. After preparation of the canals, the smear layer was removed using a rinse of 5 ml of either 17% EDTA or 10 % CA depending on the group, which was ultrasonically activated for 3 minutes. Then the final irrigation was done using 5 ml of corresponding primary irrigant of the group. The root canal walls were then dried using paper points. Calcium hydroxide paste mixed with sterile saline was placed with Lentulo spiral fillers in the entire root canal extent and the access cavity was restored with Cavit. The dressing was left in place for 7 days. At the second visit, the temporary restoration was removed. The intracanal dressing was removed with 5 ml of corresponding primary irrigant and with gentle filing with the use of Hedstroem file. The root canal was then irrigated with 5 ml of corresponding chelating agent with ultrasonic activation followed by 5 ml of primary irrigants of the corresponding group. The canals were dried and obturated with the GuttaPercha using lateral condensation technique and Zinc Oxide- Eugenol based sealer in both the groups. After obturation, the tooth was restored permanently. Immediate post-operative radiograph was then taken using preset exposure parameters with Rinn paralleling device. Follow up clinical and radiographic examinations were carried out every 3 months, till 12 months period.

Statistical analysis: The data gathered will be analyzed using suitable statistical methods.

Being tested
sodium hypochlorite, chlorhexidine
Keywords
Retreatment, Irrigants, chlorhexidine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sodium hypochloriteProcedure or surgery

    sodium hypochlorite is used as primary irrigant and edta is used as secondary irrigant in endodontic retreatment cases

  • chlorhexidineProcedure or surgery

    Chlorhexidine is used as primary irrigant and citric acid is used as secondary irrigant in endodontic retreatment cases

Study groups in NCT03719404
Study groupRoleWhat they receive
sodium hypochlorite groupExperimentalsodium hypochlorite and EDTA are used in endodontic retreatment cases
Receives: Procedure: sodium hypochlorite
chlorhexidine groupExperimentalchlorhexidine and citric acid are used in endodontic retreatment cases
Receives: Procedure: chlorhexidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Radiographic success

    Follow up will be done every 3 months till 12 months. Scoring of each tooth will be done according to the following five point scale (PAI). 1- normal periapical structures 2-Small changes in bone structure 3-Changes in bone structure with some mineral loss 4-Periodontitis with well-defined radiolucent area 5-Severe periodontitis with exacerbating features

    Instructions for scoring using PAI:

    • All teeth must be given a score
    • When in doubt assign higher score
    • For multirooted teeth, use the highest of the scores given to the individual roots.

    Success was calculated as a dichotomous variable with teeth showing a PAI score of ≤ 2 considered as healed, while those showing a score of ≥3 considered as nonhealed.

    Measured: Baseline to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study startOct 2016
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

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
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
103 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03719404
Sponsor's protocol ID
Kaarunya
Status last verified
Oct 2018
First submitted
23 Oct 2018
Last updated
6 Nov 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing sodium hypochlorite and chlorhexidine in people with Root Canal Infection, run by Postgraduate Institute of Dental Sciences Rohtak.

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 5 inclusion and 1 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: finished, as of the sponsor's last update on 6 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Radiographic success (time frame: Baseline to one year). 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 6 Nov 2018.

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