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

NCT06002646 | Completed Phase 4 DMC

• 2 other identifiers: USaimaniRegistration No.: 159/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulp Disease, Dental; Pulp Mummification

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

first group (Group A)

ACTIVE COMPARATOR

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

second group (Group B)

EXPERIMENTAL

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

third group (Group C)

EXPERIMENTAL

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

fourth group (Group D)

EXPERIMENTAL

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

Interventions

Formocresol DRUG

Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with Formocresol solution

Also known as: Buckley's solution

first group (Group A)

Sodium Hypochlorite Solution DRUG

Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 3% Sodium Hypochlorite Solution.

Also known as: NaOCl

second group (Group B)

Diode laser DEVICE

Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 940 nm diode laser.

third group (Group C)

Er,Cr:YSGG laser DEVICE

Hemostasis of pulpal tissue in primary teeth pulpotomy techniques with 2790nm Er,Cr:YSGG laser.

Also known as: Erbium, Chromium: Yttrium-Scandium-Gallium-Garnet laser

fourth group (Group D)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (1)

Wasan Adil Fadhil

Sulaymaniyah, Iraq

Location

Related Publications (1)

• Fadhil WA, Noori AJ. Clinical and Radiographic Evaluation of Diode and Er,Cr:YSGG Lasers as an Alternative to Formocresol and Sodium Hypochlorite for Pulpotomy Techniques in Primary Molars: A Randomized Controlled Clinical Trial. Cureus. 2024 Jul 31;16(7):e65902. doi: 10.7759/cureus.65902. eCollection 2024 Jul.

  PMID: 39219956 DERIVED

MeSH Terms

Conditions

Dental Pulp Diseases; Dental Pulp Necrosis

Interventions

formocresol; Sodium Hypochlorite; Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 21, 2023
• Study Start: January 4, 2023
• Primary Completion: June 8, 2023
• Study Completion: April 4, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

IR (1)