Clinical trial

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

Name

#12

Description

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

Trial arms

Trial start

2022-12-01

Estimated PCD

2024-06-01

Trial end

2024-06-01

Status

Recruiting

Treatment

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.

Arms:

Photobiomodulation

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

Arms:

Mineral Trioxide Aggregate (MTA)

Size

Primary endpoint

Clinical success of pulpotomy

up to 12 months

Radiographic success of pulpotomy

up to 12 months

Tissue healing

24 hours

Eligibility criteria

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).

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}

Updated at

2023-05-09

1 organization

1 product

2 indications

Organization

Product

Indication

Indication