NCT03298165

Brief Summary

This study will be conducted to assess antibacterial effect of the diode laser in deep carious cavity after step wise excavation using the bacteriological assessment method.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

September 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

1 month

First QC Date

September 27, 2017

Last Update Submit

January 23, 2018

Conditions

Antibacterial Effect of Diode Laser

Outcome Measures

Primary Outcomes (1)

  • bacteriological count

    dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab

    30 minute

Study Arms (2)

disinfection the cavity with diode laser

EXPERIMENTAL

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

Device: diode laser

no cavity disinfection

PLACEBO COMPARATOR

placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .

Device: diode laser

Interventions

diode laserDEVICE

diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation

disinfection the cavity with diode laserno cavity disinfection

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with at least two deep occlusal carious lesion .
  • years.
  • Males or Females.
  • Good oral hygiene.
  • Co-operative patients approving the trial and willing to sign a written consent.

You may not qualify if:

  • Pregnancy.
  • Systemic disease or severe medical complications.
  • Heavy smoking.
  • Xerostomia.
  • Lack of compliance.
  • Evidence of temporomandibular joint disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
outcome assessor the assessor will not be blind about the type of intervention/control assessment methods. however it will not be allowed amongst the examiners to exchange any information throughout the entire study period
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
internal resident

Study Record Dates

First Submitted

September 27, 2017

First Posted

October 2, 2017

Study Start

February 1, 2018

Primary Completion

March 15, 2018

Study Completion

June 1, 2018

Last Updated

January 25, 2018

Record last verified: 2018-01