Lasers as an Alternative to Formocresol and Sodium Hypochlorite Medicaments in Pulpotomy Techniques

April 18, 2024 updated by: Wasan Adil, University of Sulaimani

Clinical and Radiographic Evaluation of Diode and Er:Cr;YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Technique in Primary Molars - Randomized Controlled Clinical Trial

The goal of this clinical trial is to evaluate the dental lasers as an alternative of chemical medicaments used in the pulpotomy procedures. The main question it aims to answer is:

• Lasers pulpotomies are a viable alternative to the standard Formocresol and Sodium Hypochlorite medicaments.

All participants groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) for pulpotomy procedure will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies which either will be achieved by Formocresol or Sodium Hypochlorite solutions or by Diode or Erbium lasers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All the selected treatment groups (Formocresol, Sodium Hypochlorite, Diode and Er:Cr;YSGG lasers) will follow the same clinical protocol, except for the techniques that will be used for hemostasis of the pulpotomies:

  1. Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic.
  2. Isolation of the teeth with a rubber dam.
  3. Using a diamond round #440 bur in a high-speed hand piece with water cooling to eliminate caries and expose pulp chambers.
  4. Using a spoon excavator to remove the coronal pulp.
  5. Achieving the hemostasis by:

I. In first group (Group A): using a 1:5 dilution of Buckley's FC solution. A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research.

II. In the second group (Group B): using 3% NaOCl. A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA.

III. In the third group (Group C): In this group hemostasis will be achieved by exposure to diode laser of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW (According to the user manual) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.

IV. In the fourth group (Group D): Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm ) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.

  1. Then covering the surface with a 2 mm layer of MTA
  2. The final restoration will be completed in all the four groups, stainless steel crown will be placed as the final restorative material with a well-fitting marginal adaption and glass ionomer cement(GC company).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

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

  • Iraq
      • Sulaymaniyah, Iraq
        • Wasan Adil Fadhil

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:

  • Deep carious lesions present in primary molars.
  • No history of spontaneous or persistent pain.
  • Lack of clinical evidence of pulpal degeneration, such as pain on percussion, history of swelling or sinus tracts.
  • Restorable teeth following completion of the procedure.
  • Absence of radiographic signs and symptoms of pulpal degeneration.
  • Following pulpal amputation, hemostasis could be easily achievable.

Exclusion Criteria:

  • Uncooperative children.
  • Children with medically compromised disease.
  • Presence of radiographical signs and symptoms of pulpal degeneration.
  • Physiologic root resorption is more than one-third.

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: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: first group (Group A)
using a 1:5 dilution of Buckley's FC (SSA, Produits Dentaires, Switzerland). A sterile cotton pellet will be moistened with a 1:5 concentration formocresol and it will be placed on the pulp stumps for 5 minutes for achieving hemostasis before being covered with MTA. If hemostasis will not be achieved after 5 minutes, it will presume that the pulp tissue in the canal was infected, and the tooth will be removed from the research
Drug: Formocresol
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution
Other Names:
  • Buckley's solution
Experimental: second group (Group B)
using 3% NaOCl(Tahno-dent, Greece) A sterile cotton pellet will be moistened with a 3% NaOCl and it will be placed on the pulp chamber for 5 minutes for achieving hemostasis before being covered with MTA
Drug: Sodium Hypochlorite Solution
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.
Other Names:
  • NaOCl
Experimental: third group (Group C)
In this group hemostasis will be achieved by exposure to diode laser (Biolase, epic X) of 940 nm. The laser energy will be introduced into the canal orifice through a 300 µm optical fiber at 2 W, in a contact mode with continuous mode CW(According to the user manual('EpicX_CAN_UM.pdf', no date) for 1 second at each orifice for three times to achieve complete hemostasis. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
Device: Diode laser
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.
Experimental: fourth group (Group D)
Irradiation of the floor of the pulp chamber with Er,Cr:YSGG laser 2790 nm (Waterlase MD, Biolase) at a Power of 1.5 w, Frequency of 50 Hz, mode S (soft tissue mode) , 20%air and no water with a gold handpiece and Tip type MZ6, for 10 sec.(According to the manufacturer manual iPlus™ software copyright ©2016 BIOLASE, Inc.)('WaterLase-iPlus-UM.pdf', no date). In which a fixed char layer should be formed over the pulpal tissue of the canals orifices. During laser application patients, operator and assistant will use protective eye shields according to the safety measures of the device user manual.
Device: Er,Cr:YSGG laser
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.
Other Names:
  • Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of clinical and radiographical success rate of pulpotomy procedure of FC, and NaOCl techniques and two different types of lasers Diode and Erbium Cr,YSGG lasers
Time Frame: one year
one year

Collaborators and Investigators

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

Sponsor

University of Sulaimani

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)

January 4, 2023

Primary Completion (Actual)

June 8, 2023

Study Completion (Actual)

April 4, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 15, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USaimani
  • Registration No.: 159/23 (Other Identifier: College of Dentistry/ University of Sulaimani)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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