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

Primary Purpose

Pulp Disease, Dental, Pulp Mummification

Status
Active
Phase
Phase 4
Locations
Iraq
Study Type
Interventional
Intervention
Formocresol
Sodium Hypochlorite Solution
Diode laser
Er,Cr:YSGG laser
Sponsored by
University of Sulaimani
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Disease, Dental

Eligibility Criteria

4 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wasan Adil Fadhil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Experimental

Experimental

Arm Label

first group (Group A)

second group (Group B)

third group (Group C)

fourth group (Group D)

Arm Description

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

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 1, 2023
Last Updated
August 15, 2023
Sponsor
University of Sulaimani
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1. Study Identification

Unique Protocol Identification Number
NCT06002646
Brief Title
Lasers as an Alternative to Formocresol and Sodium Hypochlorite Medicaments in Pulpotomy Techniques
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 4, 2023 (Actual)
Primary Completion Date
June 8, 2023 (Actual)
Study Completion Date
January 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sulaimani

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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: Using 2 percent lidocaine with 1: 100,000 epinephrine as a local anesthetic. Isolation of the teeth with a rubber dam. Using a diamond round #440 bur in a high-speed hand piece with water cooling to eliminate caries and expose pulp chambers. Using a spoon excavator to remove the coronal pulp. 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. Then covering the surface with a 2 mm layer of MTA 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Disease, Dental, Pulp Mummification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Masking Description
This randomized double blinded clinical trial in which both the participants(patients) and the investigator don't know about which type of treatment groups will be applied.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
first group (Group A)
Arm Type
Active Comparator
Arm Description
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
Arm Title
second group (Group B)
Arm Type
Experimental
Arm Description
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
Arm Title
third group (Group C)
Arm Type
Experimental
Arm Description
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.
Arm Title
fourth group (Group D)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Formocresol
Other Intervention Name(s)
Buckley's solution
Intervention Description
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution
Intervention Type
Drug
Intervention Name(s)
Sodium Hypochlorite Solution
Other Intervention Name(s)
NaOCl
Intervention Description
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.
Intervention Type
Device
Intervention Name(s)
Diode laser
Intervention Description
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.
Intervention Type
Device
Intervention Name(s)
Er,Cr:YSGG laser
Other Intervention Name(s)
Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser
Intervention Description
Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Wasan Adil Fadhil
City
Sulaymaniyah
Country
Iraq

12. IPD Sharing Statement

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

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