Protocol summary
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Study aim
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Evaluation of the effect of Protact mouthwash on local complications caused by wisdom tooth surgery
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Design
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A clinical trial with a control group, single-blind, randomized, crossover, on 33 patients, the kitset.ir site was used for randomization.
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Settings and conduct
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This study will be performed by one-blind clinical trial. The population of this study includes patients who are candidates for bilateral mandibular wisdom tooth surgery who refer to the dental clinic of Babol University of Medical Sciences. Due to the blindness of the research method, the surgeon will not know how to code mouthwashes.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria include the following:
1- Existence of two occult or semi-occult wisdom teeth in the mandible that have almost the same appearance on both sides and both sides are operated by one surgeon.
2 - Age minimum 18 years and maximum 30 years
3- Healthy oral mucosa
Exclusion criteria are:
1- Being a smoker
2- Any systemic conditions; Such as liver and kidney diseases, fever, neutropenia, diabetes, autoimmunity
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Intervention groups
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Patients receiving Protact mouthwash.
Patients receiving normal saline mouthwash.
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Main outcome variables
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Wound healing rate and pain rate
General information
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Reason for update
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Reducing the sample size to 20 patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20220220054070N1
Registration date:
2022-07-22, 1401/04/31
Registration timing:
prospective
Last update:
2022-11-12, 1401/08/21
Update count:
1
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Registration date
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2022-07-22, 1401/04/31
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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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2022-09-23, 1401/07/01
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Expected recruitment end date
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2023-02-20, 1401/12/01
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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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Evaluation of the effect of Protact mouth rinse on topical side effects of wisdom teeth extraction and comparison with control group
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Public title
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Evaluation of the effect of Protact on oral ulcerations
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Existence of two occult or semi-occult wisdom teeth in the mandible that have almost the same view on both sides and both sides are operated by a surgeon
Age minimum 18 years and maximum 30 years
Healthy oral mucosa without mucosal or infectious lesions
Exclusion criteria:
Being a smoker
Any systemic conditions; Such as liver and kidney diseases, fever, neutropenia, diabetes, autoimmunity
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Age
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From 18 years old to 30 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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Sample size
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Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient undergoes mandibular wisdom tooth extraction twice (once for the left and once for the right) and receives one of the proactive or normal saline mouthwashes for each operation.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method was performed through the site that patients are divided into two groups that each group of people in the first surgery receive a type of mouthwash and in the second surgery, receive a second mouthwash.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Due to the blindness of the research method, the surgeon will be unaware of how to code mouthwashes.
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Placebo
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Not used
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Assignment
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Crossover
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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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2022-04-25, 1401/02/05
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Ethics committee reference number
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IR.MUBABOL.REC.1401.025
Health conditions studied
1
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Description of health condition studied
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Localized erythema of the mouth and pain
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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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Status of local mucosal erythema at the surgical site including no erythema, mild to moderate erythema and severe erythema
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Timepoint
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results3 and 7 days after surgery
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Method of measurement
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Lesions are visually examined and evaluated.
Intervention groups
1
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Description
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Intervention group: They receive Protact mouthwash containing thyme extract. Each patient is told to rinse their mouth with 5 ml of mouthwash for 1 minute twice a day, morning and night, one hour after brushing, and until An hour later, do not rinse your mouth with water and avoid eating and drinking. Start this night after surgery and continue for a week.
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Category
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Treatment - Drugs
2
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Description
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Control group: Receive mouthwash containing normal saline. Each patient is told to rinse his mouth with 5 ml of mouthwash for 1 minute for 1 minute in the morning and evening, one hour after brushing, and Do not rinse your mouth with water for an hour after that and avoid eating and drinking. Start on the night of surgery and continue for a week.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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student research committee babol university of medical sciences
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Grant code / Reference number
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724134320
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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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Babol 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