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

Sponsor

University of Sulaimani (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06002646

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental Pulp Mummification	Drug: Formocresol Drug: Sodium Hypochlorite Solution Device: Diode laser Device: Er,Cr:YSGG laser	Phase 4

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:

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.

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.
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.
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).

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

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.

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 4, 2023

Actual Primary Completion Date :

Jun 8, 2023

Anticipated Study Completion Date :

Jan 4, 2024

Arms and Interventions

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

Outcome Measures

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 [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 8 Years

Sexes Eligible for Study:

All

Accepts 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.