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

NCT05850780 | Unknown

• 1 other identifier: #12
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulpitis; Pulpotomy

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Photobiomodulation

EXPERIMENTAL

Device: Photobiomodulation

Mineral Trioxide Aggregate (MTA)

ACTIVE COMPARATOR

Drug: MTA

Interventions

Photobiomodulation DEVICE

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.

Photobiomodulation

MTA DRUG

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

Mineral Trioxide Aggregate (MTA)

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Aliaa Hamouda: lead

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

RECRUITING

MeSH Terms

Conditions

Pulpitis

Interventions

Low-Level Light Therapy; Pemetrexed

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Study Officials

• Aliaa Hamouda, MSc

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Amani Khalil, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Laila El-Habashy, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Aliaa Hamouda, MSc

CONTACT

01062680616; aliaa.hamouda@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Pediatric Dentistry

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 9, 2023
• Study Start: December 1, 2022
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

EG (1)