NCT03631277

Brief Summary

This study aimed to assess the clinical and radiographic success for photo-activated oral disinfection (PAD) and calcium hydroxide in indirect pulp treatment (IPT) of young permanent molars.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration 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

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 12, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2018

Completed
Last Updated

August 15, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 12, 2018

Last Update Submit

August 14, 2018

Conditions

Deep Caries

Keywords

Indirect pulp treatmentPhoto-activated oral disinfectionCalcium Hydroxide

Outcome Measures

Primary Outcomes (4)

  • postoperative pain: verbal rating scale

    categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome

    2 months

  • postoperative pain: verbal rating scale

    categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome

    6 months

  • postoperative pain: verbal rating scale

    categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome

    9 months

  • postoperative pain: verbal rating scale

    categorical (No pain, Mild pain, Moderate, Severe, Very Severe, Worst possible pain ). Assessed by using verbal rating scale. minimum value is no pain while maximum value is worst possible pain. Higher values represent a worse outcome.

    12 months

Secondary Outcomes (5)

  • Presence or absence of pain on percussion

    2,6,9 and 12 months

  • Swelling

    2,6,9 and 12 months

  • Sinus or fistula

    2,6,9 and 12 months

  • Adverse radiographic findings

    2,6,9 and 12 months

  • Thickness of newly formed dentin

    2,6,9 and 12 months

Study Arms (2)

photo-activated oral disinfection

EXPERIMENTAL

photo-activated oral disinfection is an advanced technology utilizing two non-toxic components, a photo-activating liquid and a LED light source that selectively target and abolish cariogenic bacteria and periodontal pathogens

Device: photo-activated oral disinfection

calcium hydroxide

ACTIVE COMPARATOR

Calcium hydroxide is the gold standard for pulp capping, it permits reparative dentin bridge formation, maintains pulp vitality, protects the pulp against harmful stimuli and has antimicrobial effect

Drug: Calcium Hydroxide

Interventions

photo-activated oral disinfectionDEVICE

Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration

Also known as: PAD
photo-activated oral disinfection
Calcium HydroxideDRUG

calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration

Also known as: Ca(OH)2
calcium hydroxide

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Restorable lower first permanent molars with deep carious lesions
  • Absence of clinical signs and symptoms of irreversible pulpitis, fistula, swelling in periodontal tissues or abnormal tooth mobility
  • Absence of adverse radiographic findings
  • Compliant patient/parent and (e) Absence of any systemic disease.

You may not qualify if:

  • Previously restored teeth .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Calcium Hydroxide

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsCalcium CompoundsAnionsIonsElectrolytes

Study Officials

  • Ahmed M Abd Alsamad, PHD

    Cairo University

    STUDY DIRECTOR

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
PRINCIPAL INVESTIGATOR
PI Title
Assistant Lecturer of Pediatric Dentistry and Dental public health, Faculty of Dentistry, Cairo University, Egypt.

Study Record Dates

First Submitted

August 12, 2018

First Posted

August 15, 2018

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

April 1, 2017

Last Updated

August 15, 2018

Record last verified: 2018-08