Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)
Clinical evaluation of the effectiveness of purified bioactive peptides from Spirulina platensis algae in healing process of wounds caused by periodontal flap surgery with a double-blind randomized clinical trial:
Design
Target group: patients referred to the periodontics department of Tabriz university of medical Sciences, faculty of dentistry
Sample size: 30 patients diagnosed with periodontitis and indicated for periodontal flap surgery in at least 2 separate areas.
Settings and conduct
After purification of spirulina protein and enzymatic hydrolysis with free enzymes and the production of gel containing spirulina bioactive compounds, the effects of spirulina bioactive compounds will be checked on patients who are candidates for periodontal flap surgery by comparing the variables in the two areas of the gel used with the control area.
Participants/Inclusion and exclusion criteria
Having a favorable general health condition
Being available during the 12 weeks of study
Non- smoker patients
Diagnosis of periodontitis and indication of periodontal flap surgery
Pregnant women
People who had used antibiotics and anti-inflammatory drugs within a month before surgery
Patients who use orthodontic appliances
Patients using the removable prosthesis
Patients with intraoral pathological conditions
Patients with a history of allergic reaction to health care products
Intervention groups
One of the surgical sites will be randomly selected as the intervention group and the tested substance will be used in this area.
The other surgical site will be randomly selected as the intervention group and no substance will be used in this area.
Main outcome variables
swelling, gum color, pocket probe depth, clinical attachment loss, bleeding index, plaque index, amount of pain experienced, type of pain, number of painkillers used, bleeding gums
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221021056257N1
Registration date:2022-11-09, 1401/08/18
Registration timing:prospective
Last update:2022-11-09, 1401/08/18
Update count:0
Registration date
2022-11-09, 1401/08/18
Registrant information
Name
Pouya Almassi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3662 5957
Email address
pouyaalmassi77@gmial.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-11-12, 1401/08/21
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)
Public title
Clinical evaluation of the efficacy of purified bioactive peptides from Spirulina Platensis algae on the healing of wounds after periodontal flap surgery (double-blinded randomized clinical trial)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a favorable general health condition
Being available during the 12 weeks of study
Non- smoker patients
Diagnosis of periodontitis, as defined by at least three non-contiguous interproximal pockets with pocket depth (PPDs) greater than 4mm or other radiographic evidence such as alveolar bone loss
Patients who show PPD ≥ 6mm after non-surgical treatment and periodontal surgery is indicated.
Exclusion criteria:
Pregnant women
People who had used antibiotics and anti-inflammatory drugs within a month before surgery
Patients who use orthodontic appliances
Patients using the removable prosthesis
Patients with intraoral pathological conditions
Patients with 5 or more decayed teeth
Patients who had participated in another study during the last 1 month
Patients with a history of allergic reaction to health care products
Patients who are forbidden to eat or drink liquids for 4 hours due to medical conditions
Age
From 18 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Presence of at least 2 separate sites with the indication of periodontal flap surgery in the mouth
Randomization (investigator's opinion)
Randomized
Randomization description
The sample selection method in the stage of allocating the type of treatment is randomized controlled sampling. In this method, the list of qualified people will be entered into Excel software and people will be randomly selected from the statistical population.
Blinding (investigator's opinion)
Double blinded
Blinding description
For blinding, Sealed envelope will be used and it will be given to the doctor by the patient. In other words, in this study, the surgical site is selected randomly and after opening the envelope, the doctor is going to use a gel containing spirulina bioactive compounds for the wound on one side, and the wound on the other side is considered as a control, and no special substance will be used. Also, the study is double-blind, and the evaluating student and the patient will not know about the case and the control.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tabriz University of Medical Sciences
Street address
Research development and coordination center (RDCC), faculty of medicine, Tabriz university of medical sciences, Attar Neyshaburi St., Golgasht, St. Azadi St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166/15731
Approval date
2022-10-10, 1401/07/18
Ethics committee reference number
IR.TBZMED.REC.1401.654
Health conditions studied
1
Description of health condition studied
Wounded tissue caused by periodontal flap surgery
ICD-10 code
T81.3
ICD-10 code description
Disruption of wound, not elsewhere classified
Primary outcomes
1
Description
Clinical variables evaluated after surgery include soft tissue swelling, gum color, pocket probe depth, clinical attachment loss, bleeding index, plaque index. Also, during the first 7 days after surgery, patients will complete a questionnaire to evaluate post-surgery complaints, which includes the amount of pain experienced, the type of pain, the number of painkillers taken, swelling of the mucous membrane and swelling of the face, and swelling and bleeding of the gum.
Timepoint
Examining the results of wound healing 1, 4 and 8 weeks following the surgery
Method of measurement
In order to check the amount of Swelling, the number 0 will be used for the absence of Swelling, the number 1 for moderate Swellingand 2 for significant Swelling. In order to evaluate the color of the gums, while comparing with the opposite side, the numbers 0 will be used for no redness, 1 for moderate redness and 2 for significant redness. To measure the depth of the probe pocket and CAL, the reference of these measurements will be from the Cementoenamel Junction. Bleeding index and Plaque index will be measured on 6 surfaces of the involved teeth and finally the measurements will be presented as an average. The presence or absence of bleeding during the probe will be recorded with two scales: 0 for no bleeding and 1 for bleeding. The presence or absence of plaque will also be measured with the same scale along the gingival margin. Also, to measure the variables of the questionnaire, in order to check the level of pain, the Visual Analogue Scale, which is a visual analog index with a degree of pain from 0 to 10, will be used. The amount of swelling of the mucous membrane and face will be asked with two options: no swelling and high swelling, and the presence or absence of bleeding in the area after surgery will be asked. The patient is requested not to refer to the information of the previous days when completing the questionnaire daily.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One of the surgical sites will be randomly selected as the intervention group and the tested substance will be used in this area.
Category
Treatment - Drugs
2
Description
Control group: the other surgical site will be randomly selected as the intervention group and no substance will be used in this area.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Tabriz university of medical sciences, department of periodontics
Full name of responsible person
Dr. Masoumeh Faramarzi
Street address
Dentistry Faculty of Tabriz university of medical sciences, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Email
pouyaalmassi77@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Kouhsoltani
Street address
Dentistry Faculty of Tabriz university of medical sciences, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Email
pouyaalmassi77@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Kouhsoltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Oral & Maxillofacial Pathology
Street address
Azadi Blvd., Golgasht St., Dentistry Faculty of Tabriz university of medical sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Email
mkoohsoltani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Kouhsoltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
ral & Maxillofacial Pathology
Street address
Dentistry Faculty of Tabriz university of medical sciences, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Email
mkoohsoltani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Maryam Kouhsoltani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Oral & Maxillofacial Pathology
Street address
Dentistry Faculty of Tabriz university of medical sciences, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 5965
Email
mkoohsoltani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
-
Under which criteria data/document could be used
-
From where data/document is obtainable
-
What processes are involved for a request to access data/document