Clinical and Radiographic Evaluation of Photodynamic Therapy for Root Canal Treatment of Primary Molars

April 6, 2023 updated by: Mohamed Elsayed Abo Farrag, Mansoura University
This study will be conducted to evaluate clinical and radiographic success of Photodynamic Therapy for root canal treatment of primary molars in comparison to the standard root canal treatment.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 35511
        • Mohamed El Sayed Abo Farrag

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children aged 4-7 years.
  • Apparent healthy child not suffering from any mental or physical disability.
  • Cooperative children.
  • Restorable teeth.
  • Each child should have at least one carious primary molar with signs and symptoms of irreversible pulpitis or pulp necrosis.
  • Absence of internal and / or external perforation in the furcation area.
  • At least 2/3 thirds of the roots should be remained.

Exclusion Criteria:

  • Children with compromised health or physical disability.
  • Resorption of the roots more than 2/3 thirds.
  • Non restorable teeth.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: standard root canal treatment
Procedure: pulpectomy with metapex
root canal treatment using standard technique
Other: photodynamic therapy
Device: photodynamic therapy
root canal treatment of primary molars using photodynamic therapy
Other: instrumentation and photodynamic therapy
Device: photodynamic therapy
root canal treatment of primary molars using photodynamic therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of clinical success of photodynamic therapy
Time Frame: 14 months

The following criteria will be used for the determination of treatment success or failure:

  1. Repair (= success) Clinically: absence of signs and symptoms.
  2. Lack of repair (= failure) Clinically: signs and symptoms indicative of acute apical periodontitis.
14 months
Evaluation of radiographic success of photodynamic therapy
Time Frame: 14 months

The following criteria will be used for the determination of treatment success or failure:

  1. Complete repair (= success) Radiographically: absence of pathological root resorption, normal width of periodontal ligament space, absence of lesion development in periapical regions in cases of absence of lesion in the initial diagnostic radiograph and complete regression of lesion in cases of presence of lesion in the initial diagnostic radiograph.
  2. Incomplete repair (= success) Radiographically: absence of pathological root resorption and reduction lesion size in the periapical region.
  3. Lack of repair (= failure) Radiographically: presence of pathological root resorption, lesion in furcation/periapical region unchanged in size during follow-up period, increase in lesion size or the development of a new lesion.
14 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 6, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 6, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • M02041022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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