Determination of the effect of Hypericum Perforatum extract on soft tissue healing of tooth extraction socket.
Design
The present study is a non-randomized Double-blind clinical trial phase 3 with parallel groups on 30 patients.
Settings and conduct
this study will perform on 18-30 year olds who needed bilateral extraction of maxillary premolars for orthodontic reasons between2021 jan to jun in private orthodontic offices. They are done. Individuals with inclusion criteria and no exclusion criteria are selected from those who refer to the office and after obtaining informed and written consent, enter the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People 18 to 30 years old who need bilateral maxillary premolars extraction for orthodontic reasons.
Exclusion criteria:
Pregnancy
Breastfeeding
Traumatic and surgical extractions
History of major systemic diseases and allergies
Smoking
Alcohol abuse
History of taking corticosteroids, contraceptives and antidepressants
Need to take antibiotics and NSAIDs after tooth extractions
Periodontal disease, infection or any pathology at the area of the teeth indicated for extraction
Need more than one carpule to create local anesthesia
Who are not willing to participate during the follow ups
Intervention groups
Test site: 2ml of biocompatible herbal gel(Hypericum perforatum) will be placed in the postextraction socket and then the socket will be covered with a piece of gauze moistened with normal saline solution.
Control site: After a gentle wash with normal saline, the moistened sterile gauze is covered with normal saline.
Main outcome variables
Pain intensity; Wound size; Wound healing rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210113050025N1
Registration date:2021-01-21, 1399/11/02
Registration timing:prospective
Last update:2021-01-21, 1399/11/02
Update count:0
Registration date
2021-01-21, 1399/11/02
Registrant information
Name
Faranak Shafiee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 8770
Email address
faranak.shafiee@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-30, 1399/11/11
Expected recruitment end date
2021-04-20, 1400/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of Hypericum Perforatum extract on soft tissue healing of tooth extraction socket.
Public title
ٍٍEffect of Hypericum Perforatum extract on tissue healing.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People 18 to 30 years old
bilateral maxillary premolars extraction for orthodontic reasons
Exclusion criteria:
Pregnancy
Breastfeeding
Traumatic and surgical extractions
History of systemic diseases and allergies
Smoking
Alcohol abuse
History of taking corticosteroids, contraceptives and antidepressants
Need to take antibiotics and NSAIDs after tooth extractions
Periodontal disease, infection or any pathology at the area of the tooth indicated for extraction
Need more than one carpule to create local anesthesia
Who are not willing to participate during the follow ups
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left Maxillary premolar postextraction sockets
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants are not informed in which direction the intervention will take place.
The socket one side is randomly selected as the test area and the opposite side as the control. Be. If the selected number is even, the right side is defined as the intervention and the left side as the control, and if it is odd, the left side is defined as the intervention and the right side as the control.
The dentist who puts herbal gel in the socket identifies the intervention site with a color code in the checklist.
The researcher who examines the tooth socket in follow up sessions evaluate the healing process without knowing the meaning of the code.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of medical Sciences
Street address
Pasdaran ave , Kurdistan University of medical Sciences
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.MUK.REC.1399.263
Health conditions studied
1
Description of health condition studied
postextraction socket healing
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Healing score
Timepoint
Third and seventh day after tooth extraction
Method of measurement
Healing index by Landry, Turnbull and Howley
2
Description
Wound size
Timepoint
Extraction day (baseline), third and seventh day after tooth extraction
Method of measurement
Castroviejo caliper
Secondary outcomes
1
Description
Pain severity
Timepoint
Extraction day (baseline), third and seventh day after tooth extraction
Method of measurement
Numeric Pain Rating Scale
Intervention groups
1
Description
Intervention group: After achieving adequate anesthesia and tooth extraction the dentist will place 2ml of 5% gel containing Hypericum Perforatum extract with the use of a syringe in the intervention side socket and then he will put a piece of gauze moistened with normal saline solution on it and ask the patient to keep the gauze piece in place for 45 min.
Category
Treatment - Drugs
2
Description
Control group: After rinsing gently with normal saline,a piece of gauze moistened with normal saline solution (NSS) will be placed on the socket wound, and the patient is asked to hold the gauze in place for 45 minutes.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshad Moradi DDS Densitary Clinic
Full name of responsible person
Farshad Moradi
Street address
In front of the Education Organization, At the beginning of Palestine Street, Azadi Square
City
Sanandaj
Province
Kurdistan
Postal code
6616894581
Phone
+98 87 3328 8833
Email
faranakshafiee@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Kurdistan University of medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4645
Email
maleki43@yahoo.com
Grant name
Grant code / Reference number
IR.MUK.REC.1399.263
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Zahra Haghighatpasand Astaneh
Position
Dentistry intern
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Kurdistan University of medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4648
Email
sogand.haqiqat76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Faranak Shafiee
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Densitary Faculty, Kurdistan University of medical Sciences,Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 4648
Email
faranakshafiee@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Zahra Haghighatpasand Astaneh
Position
Dentistry intern
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Dentistry faculty, Kurdistan University of medical Sciences, Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 8770
Email
sogand.haqiqat76@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is from the proposal, raw data and project reports
When the data will become available and for how long
Data is available from the legal system six months after publication for two years
To whom data/document is available
All persons will be able to access the Kurdistan University of Medical Sciences's request to the Kurdistan University of Medical Sciences.
Under which criteria data/document could be used
For legal issues and the need to use data in future studies