Effect of using Aloe vera gel on wound healing following periodontal flap surgery
Design
Two arm parallel group randomized double blinded trial with control group
Settings and conduct
This clinical trial will be performed on 22 patients at Tabriz Dental School.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient with indication of Widman flap
Non-inclusion criteria:History of antibiotic therapy in the past two months; the presence of e systemic disease that affects the periodontal condition; taking medication or having conditions that affect the periodontal condition; smoking; aggressive periodontitis
Intervention groups
Intervention group: One side of patient's jaw is inserted with aloevera gel with periodontal dressing
Control group:on the opposite side of the same patient's jaw is placed a periodontal dressing without the aloevera gel
Effect of using Aloe vera gel on wound healing following periodontal flap surgery (clinical trial)
Public title
Effect of Aloe vera gel on wound healing following gingival surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with indication of widman flap
Exclusion criteria:
Antibiotic use history up to 6 months
The presence of a systemic disease that affects the periodontal condition
Taking medication or having conditions that affect the periodontal condition
Smoking
Aggressive Periodontitis
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
patients with odd ID are treated right side and patient whit even ID are treated left side
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the aloe vera gel is mixed with the dressing and inserted after surgery, the patient is not aware of the use of aloe vera. On the other hand, the researcher is a non-surgical surgeon and has no knowledge of the gel used in the area.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
Tehran
Province
Tehran
Postal code
2181455618
Approval date
2019-10-10, 1398/07/18
Ethics committee reference number
IR.TBZMED.REC.1398.681
Health conditions studied
1
Description of health condition studied
Periodontosis
ICD-10 code
K05.4
ICD-10 code description
Periodontosis
Primary outcomes
1
Description
pain
Timepoint
3, 7, 14 days after surgery
Method of measurement
Visual Analogue Scale (VAS)
2
Description
gingival color
Timepoint
7, 14 days after surgery
Method of measurement
visual (Red, coral pink, dark pink)
3
Description
granulation tissue
Timepoint
7, 14 days after surgery
Method of measurement
Visual (less than 2 mm mild, more than 2 mm severe)
4
Description
gingival consistency
Timepoint
7, 14 days after surgery
Method of measurement
periodontal prob
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aloe vera gel in one side of the patient's jaw is put with periodontal dressing. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception).
Category
Treatment - Other
2
Description
Control group: On the opposite side of the patient's jaw, periodontal dressing is inserted without aloe vera gel. At 7 and 14 days after surgery, patients will be evaluated and clinical parameters of gingival color and gingival consistency and granular tissue will be evaluated. At the 7th day after surgery, the patient will be asked about the ease of nutrition after surgery, as well as the pain measurement guideline, previously taught to patients, to provide patients with pain relief. In the first 3 days after surgery, they will be assessed using the Vissual Analog Scale (VAS) from zero (pain free) to 10 (worst pain perception).
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentisty faculty Tabriz university of medical sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Street address
School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3336 3299
Fax
+98 41 3336 3299
Email
chitsazm@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mojhgan Kachooei
Street address
School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
info@dentistryfac.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Mohammad Taghi Chitsazi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Position
professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Taghi Chitsazi
Position
professoe
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
School of Dentistry, Tabriz University of Medical Sciences, University Avenue, University Circle, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mtchitsazi@gmail.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
Undecided - It is not yet known if there will be 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