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

Not Applicable

Recruiting

• Conditions: Pulpitis; Pulpotomy
• Interventions: Device: Photobiomodulation; Drug: MTA

• Registration Number: NCT05850780
• Lead Sponsor: Aliaa Hamouda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2023-04
• Study First Submitted: 2023-04-29
• Study First Submitted QC: 2023-04-29
• Last Update Submitted: 2023-04-29
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Photobiomodulation	Photobiomodulation	-
Mineral Trioxide Aggregate (MTA)	MTA	-

Primary Outcome Measures

Name	Time	Method
Clinical success of pulpotomy	up to 12 months	Patients will be assessed and the presence of any adverse clinical signs or symptoms pain, or swelling will be considered clinical criteria of failure
Radiographic success of pulpotomy	up to 12 months	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.
Tissue healing	24 hours	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt