Back to resultsClinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children
Primary Purpose
Pulpitis, Pulpotomy
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Photobiomodulation
MTA
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis
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).
Sites / Locations
- Faculty of Dentistry, Alexandria UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Photobiomodulation
Mineral Trioxide Aggregate (MTA)
Arm Description
Outcomes
Primary Outcome Measures
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
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850780
Brief Title
Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children
Official Title
Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children (A Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Aliaa Hamouda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study aimed to evaluate the clinical and radiographic outcomes of photobiomodulation pulpotomy compared to MTA pulpotomy in primary molars in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis, Pulpotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Photobiomodulation
Arm Type
Experimental
Arm Title
Mineral Trioxide Aggregate (MTA)
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Photobiomodulation
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
MTA
Intervention Description
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
Primary Outcome Measure Information:
Title
Clinical success of pulpotomy
Description
Patients will be assessed and the presence of any adverse clinical signs or symptoms pain, or swelling will be considered clinical criteria of failure
Time Frame
up to 12 months
Title
Radiographic success of pulpotomy
Description
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.
Time Frame
up to 12 months
Title
Tissue healing
Description
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.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aliaa Hamouda, MSc
Phone
01062680616
Ext
+2
Email
aliaa.hamouda@alexu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aliaa Hamouda, MSc
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amani Khalil, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Laila El-Habashy, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aliaa Hamouda, MSc
Phone
01062680616
Ext
+2
Email
aliaa.hamouda@alexu.edu.eg
12. IPD Sharing Statement
Learn more about this trial
Clinical and Radiographic Evaluation of Laser Photobiomodulation Pulpotomy of Primary Molars in Children
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