NCT04373018

Brief Summary

This study will evaluate the synergistic effect of CHX + H2O2 when used as an irrigant during biomechanical preparation.in root canal treatment on periapical healing and compared with Chlorhexidine( CHX) and Sodium Hypochlorite (NaOCl).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 4, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

May 4, 2020

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

April 22, 2020

Last Update Submit

April 29, 2020

Conditions

Periapical Periodontitis

Keywords

Sodium hypochloriteChlorhexidineHydrogen peroxide

Outcome Measures

Primary Outcomes (1)

  • Clinical success

    Absence of signs and symptoms Absence of tenderness to percussion Tooth mobility of grade 1 or less Absence of associated soft tissue swelling or tenderness to palpation Attachment loss of less than 5mm . Two experienced observers with no knowledge of the treatment protocol will independently examine the immediate post obturation and follow up radiographs, mounted side by side, under controlled conditions. The treatment is considered successful only when both clinical and radiographic criteria are met. The worst outcome of an individual root decide the overall outcome for the tooth. In the event of disagreement, the two observers will meet to discuss their findings and came to an agreement.

    Base line to 1 year.

Secondary Outcomes (2)

  • Radiographic success

    Baseline to 1 year

  • Pain assessment

    Baseline to 7 days

Study Arms (3)

Sodium hypochlorite

ACTIVE COMPARATOR

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Sodium hypochlorite during biomechanical preparation.

Procedure: Sodium hypochlorite

Chlorhexidine

ACTIVE COMPARATOR

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using Chlorhexidine during biomechanical preparation.

Procedure: Chlorhexidine

Chlorhexidine + Hydrogen peroxide

EXPERIMENTAL

Procedure/Surgery: Thirty mandibular molars treated with root canal treatment by using a combination of Chlorhexidine + Hydrogen peroxide during biomechanical preparation.

Procedure: Chlorhexidine + Hydrogen peroxide

Interventions

Sodium hypochloritePROCEDURE

Sodium hypochlorite irrigant will be used during biomechanical preparation.

Sodium hypochlorite
ChlorhexidinePROCEDURE

Chlorhexidine irrigant will be used during biomechanical preparation.

Chlorhexidine
Chlorhexidine + Hydrogen peroxidePROCEDURE

Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.

Chlorhexidine + Hydrogen peroxide

Eligibility Criteria

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

You may qualify if:

  • All patients over 18 years of age.
  • Mature permanent mandibular molars.
  • A radiographic evidence of periapical radiolucency (minimum size \> 2mm×2mm) and a diagnosis of pulpal necrosis, as confirmed by the negative response to cold and electrical tests; and absence of bleeding on entering the pulp chamber.

You may not qualify if:

  • Diabetics, immunocompromised patients, pregnant females, any systemic disease.
  • Patients with a history of analgesic intake within the past 3 days and antibiotics in the last month.
  • Patients with pockets ≥ 4mm or having marginal or furcal bone loss due to periodontitis.
  • Non-restorable tooth, fractured, perforated roots and inflammatory root resorption.
  • Teeth those are not suitable for rubber dam isolation.
  • Primary teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIDS, Rohtak

Rohtak, Haryana, India

RECRUITING

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Sodium HypochloriteChlorhexidineHydrogen Peroxide

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Hypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium CompoundsBiguanidesGuanidinesAmidinesOrganic ChemicalsPeroxidesAnionsIonsElectrolytesReactive Oxygen SpeciesFree Radicals

Study Officials

  • Anshu Yadav

    PGIDS, Rohtak

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anshu Yadav

CONTACT

9050522830anshuyadav99@gmail.com

Dr Vinay Kumar

CONTACT

890114910729vinaykr@gmail.com

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 22, 2020

First Posted

May 4, 2020

Study Start

December 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

May 4, 2020

Record last verified: 2020-04

Locations

IN(1)