NCT03584880

Brief Summary

The prevention and control of post-treatment pain is of great importance for the comfort of the patient as well as for the clinician's prestige. In this study, the effect of 940 nm diode laser disinfection on the postoperative pain of retreatment cases was evaluated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 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

February 8, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
Last Updated

July 13, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

May 29, 2018

Last Update Submit

July 11, 2018

Conditions

Root Canal InfectionPain

Keywords

postoperative painDiode laserretreatment

Outcome Measures

Primary Outcomes (1)

  • Post-endodontic pain after diode laser disinfection in retreatment cases

    Pain intensity was evaluated at 24 hours after retreatment procedures. An 11-item numerical rating scale (NRS) was used to assess the pain. This NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0 -10 integers) that best reflects the intensity of their pain. Number 0 represents 'no pain' whereas number 10 represents 'pain as bad as someone can imagine'.All patients were requested to mark a number corresponding to their average pain.

    24 hours postoperatively

Secondary Outcomes (2)

  • Post-endodontic pain after diode laser disinfection in retreatment cases

    24 to 48 hours postoperatively

  • Post-endodontic pain after diode laser disinfection in retreatment cases

    48 to 72 hours postoperatively

Study Arms (2)

Diode Laser disinfection

EXPERIMENTAL

Diode laser disinfection Laser type: 940 nm diode laser Power: 1 Watt Tip: 200 micrometer fibre tip

Device: Diode laser disinfection

Pseudo Diode Laser Disinfection

PLACEBO COMPARATOR

Inactivated Diode laser application in root canal

Device: Pseudo diode laser disinfection

Interventions

Diode laser disinfectionDEVICE

Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.

Diode Laser disinfection
Pseudo diode laser disinfectionDEVICE

Without activating laser energy, same procedure as experimental group was performed (Sham laser application)

Pseudo Diode Laser Disinfection

Eligibility Criteria

Age18 Years - 52 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Only asymptomatic single rooted teeth that had an initial root canal filling diagnosed with chronic periodontitis (minimum size 2x2 mm)

You may not qualify if:

  • teeth with root canal fillings newer than 4 years, overfilled teeth, teeth with intraradicular posts, existence of a sinus tract, consumption of antibiotics within 1 month, consumption of analgesics in last 5 days, systemic disease, pregnancy, history of trauma, traumatic occlusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ozgur Genc Sen

Van, Türkiye (tur), 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • Genc Sen O, Kaya M. Effect of Root Canal Disinfection with a Diode Laser on Postoperative Pain After Endodontic Retreatment. Photobiomodul Photomed Laser Surg. 2019 Feb;37(2):85-90. doi: 10.1089/photob.2018.4539. Epub 2019 Jan 14.

    PMID: 31050927DERIVED

MeSH Terms

Conditions

PainPain, Postoperative

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ozgur Genc Sen

    Yuzuncu Yil University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

  • Melih Kaya, PhD

    Yuzuncu Yıl University, Faculty of Dentistry

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 29, 2018

First Posted

July 12, 2018

Study Start

February 8, 2018

Primary Completion

May 1, 2018

Study Completion

May 4, 2018

Last Updated

July 13, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)