NCT03277404

Brief Summary

This study evaluated the effect of removal of smear layer on the success of primary root canal treatment.Patients requiring primary root canal treatment in mature mandibular first and second molars were allocated to either smear layer positive group and smear layer negative group.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 11, 2017

Completed
Last Updated

September 11, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

June 25, 2017

Last Update Submit

September 7, 2017

Conditions

Apical Periodontitis

Keywords

EDTAPostoperative painPulp necrosisSmear layer

Outcome Measures

Primary Outcomes (2)

  • Radiographic success

    Size of apical radiolucency were scored according to PAI scores and PAI score less than 3 were considered as success

    every 3 months till 12 month period

  • Clinical success

    Presence or absence of any clinical symptoms such as pain,tenderness, sinus tract and swelling

    till 12 months

Secondary Outcomes (1)

  • Pain intensity

    Patients were asked to make a mark on the line that represented their level of perceived pain every 24hrs for7 days following intervention

Study Arms (2)

Smear Layer Positive

EXPERIMENTAL

Root canal treatment without smear layer removal: Root canal treatment and Irrigation with 1 ml of 2.5% sodium' hypochlorite for 1 min, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1minute.

Procedure: Root canal treatment without smear layer removal

Smear layer negative

ACTIVE COMPARATOR

root canal treatment with smear layer removal:Root canal treatment and Irrigation with 1 mL of 17% EDTA solution and ultrasonic activation, followed by ultrasonic activation of 3 ml of 2.5% sodium hypochlorite for 1 minute.

Procedure: Root canal treatment with smear layer removal

Interventions

Root canal treatment with smear layer removalPROCEDURE

Canal were irrigated with Naocl and EDTA to remove smear layer

Also known as: irrigation with EDTA
Smear layer negative
Root canal treatment without smear layer removalPROCEDURE

only sodium hypochlorite was used for irrigation

Also known as: irrigation with only NAOCL
Smear Layer Positive

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Mature permanent mandibular first and second molars requiring primary root canal treatment
  • Diagnosis of pulpal necrosis, as confirmed by negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber
  • Radiographic evidence of periapical radiolucency (minimum size ≥ 2.0 × 2.0 mm)
  • Patient's age more than 18 years

You may not qualify if:

  • Patients who do not provide consent for participation in the study
  • Age \<18 years
  • Positive history of antibiotic use within past one month of the treatment
  • Patients who are pregnant, diabetic, immunocompromised, had serious medical illness or required antibiotic premedication
  • Patients with pockets ≥4mm or having marginal or furcal bone loss due to periodontitis
  • Teeth that are not suitable for rubber dam isolation
  • Previously accessed teeth and/or with procedural errors
  • Unrestorable tooth, fractured/ perforated roots, inflammatory root resorption

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periapical PeriodontitisPain, PostoperativeDental Pulp NecrosisSmear Layer

Interventions

Therapeutic IrrigationEdetic Acid

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitisPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsDental Pulp DiseasesTooth DiseasesNecrosisDental Deposits

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationInvestigative TechniquesEthylenediaminesDiaminesPolyaminesAminesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic Acids

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2017

First Posted

September 11, 2017

Study Start

May 7, 2015

Primary Completion

November 30, 2015

Study Completion

November 30, 2015

Last Updated

September 11, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share