Protocol summary
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Study aim
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Comparison of clinical and radiographic outcome between diode980nanometerms laser pulpotomy and formocresol pulpotomy in primary molar teeth during 6 and 12 months follow up.
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Design
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In this research,a total of 22 healthy children with an average age of 2-10 years-old had two primary molars in two quadrants need to be pulpotomy were selected and teeth were randomly divided in two control and intervention groups
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Settings and conduct
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A pulpotomy technique is performed by a pediatrician in a private clinic. In order to complete the pulpotomy, the selected teeth of each patient should be randomly divided two group.in group one, a sterilized cotton pad with formocresol is placed on canal orifices for 5 minutes, in group two the diode980nm laser is radiated into canal orifice using a specialized handpiece for 5 seconds, and after pulp color changed ,pulp chamber is gently filled by 2 mm of reinforced ZOE and then the tooth is restored. Results of clinical evaluations and periapical radiographies of the 6th and 12th months will be recorded and compared.
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Participants/Inclusion and exclusion criteria
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1)Selected children should not have high-risk and underlying disease or contraindications to pulp treatment
2)Children with an average age of 2 to 10 years who having at least two primary molar teeth in two quadrants need to be pulpotomy
3)Teeth should not have necrotic pulp, swelling, mobility, spontaneous pain ,sinus tract ,fistula or abscess
4)Absence radiographic symptoms such as internal and external root resorption, pathologic lesions in the furcation and periapical area, pulp stone, PDL widening، loss of lamina dura
5)Pulp exposure during caries removal
6)Can be restored with amalgam or SSC
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Intervention groups
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In one intervention group,diode 980nms laser and in the other intervention group, formocresol is used
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Main outcome variables
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Clinical success; Radiograghic success
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210311050676N1
Registration date:
2021-03-21, 1400/01/01
Registration timing:
prospective
Last update:
2021-10-19, 1400/07/27
Update count:
1
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Registration date
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2021-03-21, 1400/01/01
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-03-25, 1400/01/05
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Expected recruitment end date
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2021-03-28, 1400/01/08
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of clinical and radiographic outcome between diode980nanometerms laser pulpotomy and formocresol pulpotomy in primary molars
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Public title
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Evaluation of the effect of Diode 980 nm laser on the success of deciduous teeth pulpotomy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Selected children should not have high-risk and underlying disease or contraindications to pulp treatment
Children with an average age of 2 to 10 years who having at least two primary molar teeth in two quadrants need to be pulpotomy
Teeth should not have necrotic pulp،swelling ,mobility ,spontaneous pain ,sinus tract ,fistula or abscess
Absence radiographic symptoms such as internal and external root resorption, pathologic lesions in the furcation and periapical area،,pulp stone،,PDL widening،loss of lamina dura
Pulp exposure during caries removal
Can be restored with amalgam or SSC
Exclusion criteria:
primary molar teeth with superficial caries
Teeth that fall out soon
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Age
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From 2 years old to 10 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
22
More than 1 sample in each individual
Number of samples in each individual:
2
Two
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Participants don't know which teeth have been treated with laser and which teeth have been treated with formocresol
The doctor who performs treatment, know which teeth have been treated with laser and which teeth have been treated with formocresol
Responsible for data collection and analysis don't know which teeth have been treated with laser and which teeth have been treated with formocresol
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-03-06, 1399/12/16
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Ethics committee reference number
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IR.KAUMS.MEDNT.REC.1400.013
Health conditions studied
1
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Description of health condition studied
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Vital pulp therapy in primary teeth
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Clinical success rate of treatment
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Timepoint
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6th and 12th month
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Method of measurement
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clinical observation of teeth
2
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Description
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Radiographical success rate of treatment
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Timepoint
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6th and 12th month
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Method of measurement
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periapical radiography
Intervention groups
1
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Description
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Intervention group: pulpotomy with formocresol, In this group, cotton soaked in diluted formocresol (1: 5) of master dent is placed on each orifice for 5 minutes.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: pulpotomy with DIODE980nm laser, In this group, pulpotomy with diode 980 nm laser from company nu smile simpler 2, at a distance of 1 mm from the orifice is continuously irradiated by a fiber optic with a diameter of 320 μm for 5 seconds and applied non-contact on each orifice, which if coagulation is observed Blood decreases this time.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kashan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available