Determining the effect of anaheal tablets after flap removal envelopes in medical centers of Bandar Abbas
Design
The study is a clinical trial and will be conducted in two blinds. The study population included people with chronic periodontitis who need envelope removal surgery after completing phase I periodontitis. The randomly selected individuals will be divided into two equal groups. All demographic information will be recorded before any intervention. Periodontal indices in both groups will be measured accurately. gingival index, plaque index and bleeding on probing indices will be measured according to the standard methods of articles. Envelope removal flap surgery will be performed by a periodontist according to the usual and standard methods, depending on the type of envelope and case. The first group will be given 500 mg of Anahil capsules twice a day, one hour before a meal after surgery, and the second group will be given a placebo tablet or capsule. Four weeks and eight weeks after surgery, periodontal indices will be measured again in both groups
Settings and conduct
A double-blind trial study in patients in need of envelope removal surgery referred to special offices of periodontists in Bandar Abbas
Participants/Inclusion and exclusion criteria
Inclusion criteria:
People aged 18-70 years with chronic periodontitis who need envelope removal surgery after completing phase I periodontal
Exclusion criteria:
Having a systemic disease
Smoking
Intervention groups
The intervention group is given 500 mg of Anahil capsules twice a day, one hour before a meal, after surgery.
The placebo group of placebo tablets or capsules is given twice a day, one hour before a meal.
Main outcome variables
gingival index, plaque index and bleeding on probing
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201106049289N1
Registration date:2021-04-06, 1400/01/17
Registration timing:prospective
Last update:2021-04-06, 1400/01/17
Update count:0
Registration date
2021-04-06, 1400/01/17
Registrant information
Name
Arad Mirzaagha
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4401 3227
Email address
aradf44@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-18, 1400/01/29
Expected recruitment end date
2021-04-18, 1400/01/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of anaheal tablet after flap removal pocket surgery
Public title
The effect of anaheal tablet after flap removal pocket surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with chronic periodontitis who need envelope removal surgery after completing phase I periodontitis
Exclusion criteria:
Having a systemic disease
Smoking
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done simply by tossing coins and participants will be divided into two intervention groups and a control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient receives the drug (intervention or comparison group) in sealed packets that are coded. The coding is done by one of the project partners and the dentist and the patient are blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hormozgan University of Medical Sciences
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.HUMS.REC.1399.562
Health conditions studied
1
Description of health condition studied
Periodontal disease
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
BOP values
Timepoint
Before therapeutic intervention and one month after the intervention
Method of measurement
BOP: Each tooth is probed on four levels: mesial, distal, buccal and lingual. Insert the probe gently and gently to the depth of the envelope and remove it. positive and otherwise considered BOP negative
2
Description
GI score PI index plate score
Timepoint
Measurement is performed at baseline, one week after surgery and 4 weeks after surgery
Method of measurement
Using the percentage of painted surfaces of teeth after using detectors
3
Description
Depth of Probe
Timepoint
Before therapeutic intervention and one month after the intervention
Method of measurement
Using the percentage of painted surfaces of teeth after using detectors
Secondary outcomes
1
Description
removal pocket
Timepoint
Periodontal indices will be re-measured in both groups before, four weeks and eight weeks after surgery.
Method of measurement
GI , PI and BOP indices will be measured according to the standard methods of articles.
Intervention groups
1
Description
Intervention group: Intervention group: Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then, 500 mg of Anahil capsules is given twice a day, one hour before a meal, after surgery. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods.
Category
Treatment - Drugs
2
Description
Control group: Before surgery, Gingival Index, plaque index and Bleeding on Probing indices will be measured according to standard methods. Then the second pill or capsule is given twice a day after surgery, one hour before a meal. In the first week and week 4 after surgery, GI, PI and BOP re-indices will be measured according to standard methods.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private offices of periodontal specialists
Full name of responsible person
Dr. Hossein Babazadeh
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
Babazadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bandarabbas university of medical sciences
Full name of responsible person
Dr. Teimour Aghamolaei
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
Babazadeh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bandarabbas 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
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossein Babazadeh
Position
Professor of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
Babazadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossein Babazadeh
Position
Professor of Periodontology
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
Babazadeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bandare-abbas University of Medical Sciences
Full name of responsible person
Dr. Hossein Babazadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Chamran Street
City
Bandar Abbas
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 3280
Email
Babazadeh@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD