NCT04358861

Brief Summary

The aim of study was to evaluate the effect of dental operating microscope use on the healing outcome of non surgical endodontic treatment of maxillary molars.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

April 17, 2020

Last Update Submit

April 22, 2020

Conditions

Periapical Periodontitis

Keywords

Dental Operating Microscope

Outcome Measures

Primary Outcomes (1)

  • Clinical and radiographic success

    long term clinical and radiographic success measured in terms of reduction in size of periapical radiolucency on radiograph from baseline to 12 months using PAI score 1,2 as healing and more than 2 as non healing

    12 months

Secondary Outcomes (1)

  • Number of canals located in MB root

    12 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Nonsurgical Root canal therapy was performed using dental operating microscope in the experimental group.

Procedure: Nonsurgical Root canal therapyDevice: Dental operating microscope

Control group

ACTIVE COMPARATOR

Nonsurgical Root canal therapy was performed without any magnification aid in control group.

Procedure: Nonsurgical Root canal therapy

Interventions

Nonsurgical Root canal therapyPROCEDURE

After administration of LA and rubber dam isolation, acess cavity was prepared using carbide burs. Working length was determined using root ZX apex locator and was verified radiographically. Canal preparation was done with protaper gold rotary instruments. 5ml of 5.25% NaOCl was used as irrigant. After instrumentation , the canals were irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals were dried with absorbent paper points, filled with calcium hydroxide paste and access cavity was restored with IRM.At the recall appointment ; after one week,paste removal, copious irrigation was done with 5.25% NaOCl and canals were dried with paper points. Canals were obturated with Gutta-Percha and ZOE based sealer.

Control groupExperimental group
Dental operating microscopeDEVICE

Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.

Experimental group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient willing to participate in the study
  • Age \> 18 years
  • Maxillary permanent first molar having apical periodontitis requiring primary endodontic treatment
  • Radiographic evidence of periapical radiolucency (minimum size 2 mmx 2 mm) and a diagnosis of pulpal necrosis as confirmed by negative response to cold and electrical tests and absence of bleeding on entering the pulp chamber

You may not qualify if:

  • Unwillingness of patient.
  • Retreatment cases
  • Presence of internal or external resorption ,root canal perforations during endodontic treatment and immature teeth.
  • Periodontally compromised teeth
  • Immunocompromised, diabetic, pregnant and hypertensive patients
  • Vertical root fractures
  • Teeth those are not suitable for rubber dam application

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

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

April 17, 2020

First Posted

April 24, 2020

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

January 1, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

IN(1)