Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children

Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children (A Randomized Controlled Clinical Trial)

This study aimed to evaluate the clinical and radiographic outcomes of photobiomodulation pulpotomy compared to MTA pulpotomy in primary molars in children.

Study Overview

• Status: Recruiting
• Conditions: Pulpitis; Pulpotomy
• Intervention / Treatment: Device: Photobiomodulation; Drug: MTA

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aliaa Hamouda, MSc; Phone Number: +2 01062680616; Email: aliaa.hamouda@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt, 21527
    • Recruiting
    • Faculty of Dentistry, Alexandria University
    • Contact: Aliaa Hamouda, MSc; Phone Number: +2 01062680616; Email: aliaa.hamouda@alexu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children with dental behavior score of 3 or 4 according to the Frankel behavior rating scale.
• Patients whom their maxillary primary molars are indicated for pulpotomy and SSC restoration.
• Lack of history of allergy to the materials used for anesthesia and sulfite.
• Children free of any systemic disease or special health care needs (ASA 1).
• Completion of the written informed consent form by parents/guardian.

Exclusion Criteria:

• Children who receive any analgesic drugs at least 24 hours before treatment.
• Any inflammation or lesion in the injection site
• Patients who have previous bad experience of dentistry were excluded to eliminate the possible impact of the child's previous painful or stressful experiences
• Child coming for emergency treatment of pain.
• If hemostasis is not achieved within five minutes after application of moist cotton pellet directly to the pulp stumps
• If radicular pulp tissue was not vital due to the presence of suppuration or purulent necrosis (pus discharge).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mineral Trioxide Aggregate (MTA)	Drug: MTA; Three parts of MTA powder will be mixed with one part of distilled water to obtain paste. This mixture will then be placed on the radicular pulp stumps and condensed lightly with a moistened cotton pellet. then the access cavities will be sealed with glass ionomer cement
Experimental: Photobiomodulation	Device: Photobiomodulation; A diode laser (Sirolaser blue laser system, Sirona Dental Systems GmbH, Fabrikstraße 31, 64625 Bensheim, Germany) Wavelength 660 nm will be used, and the laser parameters will be set as follows: Power 0.1 W, energy 6 J, Continuous wave; energy Tip area 0.5 cm2, fluence 12 J/cm2 will be applied to the surface of the pulp stumps for 60 seconds. The pulp chamber will then be filled with reinforced zinc oxide-eugenol (IRM, Dentsply, Mount Waverley, Australia) to ensure proper sealing. Then, each tooth in both groups will finally be restored with a stainless-steel crown (SSC)40 (3M/ESPE, St. Paul, Minn., USA) in the same visit, which will be cemented onto the tooth using glass ionomer cement. Finally, reapplication of laser with the same parameters will be done around inserted crowns to promote tissue healing and decrease post operative pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical success of pulpotomy	Patients will be assessed and the presence of any adverse clinical signs or symptoms pain, or swelling will be considered clinical criteria of failure	up to 12 months
Radiographic success of pulpotomy	Periapical x-ray will be performed and the presence of any any periapical radiolucency, furcation involvement, widening of periodontal ligament space (PDL), and pathologic internal/external root resorption will be considered radiographic failure.	up to 12 months
Tissue healing	Tissue healing after stainless steel crown (SSC) insertion will be assessed according to gingival index scale to determine the gingival condition around the inserted SSC. The adopted Löe and Silness gingival index scale ranges from 0 to 3 for the buccal, lingual, mesial and distal surfaces, and will be scored as follows: 0 indicates no inflammation and healthy gums; 1 indicates mild inflammation where there is slight color changes, slight edema and no bleeding on probing; 2 indicates moderate inflammation where there is edema with slight redness and bleeding upon probing; and 3 indicates severe inflammation where there is severe edema, redness, presence of ulceration and a tendency for spontaneous bleeding.	24 hours

Collaborators and Investigators

• Sponsor: Aliaa Hamouda
• Investigators: Study Chair: Amani Khalil, PhD, Faculty of Dentistry, Alexandria University, Egypt; Principal Investigator: Aliaa Hamouda, MSc, Faculty of Dentistry, Alexandria University, Egypt; Study Director: Laila El-Habashy, PhD, Faculty of Dentistry, Alexandria University, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: April 29, 2023
• First Submitted That Met QC Criteria: April 29, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: April 29, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Pulpitis
• Other Study ID Numbers: #12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No