Evaluation the effect of mucous adhesive nifedipine on wound healing in the palate (clinical trials)
Design
Clinical trials with a control group, with parallel groups, triple-blind
Settings and conduct
The study will be conducted on patients referring to the oral medicine department of Babol Dental School, which has a gingival recession and need to take grafts in the palate area. For each treatment group, 20 samples and a total of 40 samples were considered. Patients, examiner and outcome measurer of this study are blind (triple-blind).
Participants/Inclusion and exclusion criteria
Selection criteria: patients undergoing gingival surgery requiring graft in the palate In the age range of 20 to 50 years; exclusion criteria: systemic conditions
Intervention groups
1. gingival graft surgery with mucous adhesive, 2. gingival graft surgery with mucous adhesive nifedipine
Main outcome variables
Clinical parameters include landry restoration index, manchester restoration index, and pain visual analogue scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190430043431N1
Registration date:2019-06-21, 1398/03/31
Registration timing:retrospective
Last update:2019-06-21, 1398/03/31
Update count:0
Registration date
2019-06-21, 1398/03/31
Registrant information
Name
mina mollabnejad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1408
Email address
mmotallebnejad@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-06-19, 1398/03/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of mucous adhesive nifedipine on wound healing in the palate (clinical trials)
Public title
Evaluation the effect of mucous adhesive nifedipine on wound healing in the palate (clinical trials)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients undergoing gingival surgery requiring graft in the palate
In the age range of 20 to 50 years
Exclusion criteria:
Systemic conditions
Age
From 20 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The pharmacologist, who is the only person aware of the contents of each of the mucous of adhesives, provides 20 cards containing the nifedipine gel code, and 20 cards containing a non-nifedipine gel code. Then, each patient chooses to enter a control or case group by selecting each card.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Patients do not aware of the treatment group which they included. The outcome elevator measures the study data without any knowledge about the type of treatment.
The person who analyze data does not know the codes and he is blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol univercity of medical science
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2018-02-26, 1396/12/07
Ethics committee reference number
MUBABOL.HRI.REC.1396.209
Health conditions studied
1
Description of health condition studied
Gingival recession
ICD-10 code
K06
ICD-10 code description
Gingival recession
Primary outcomes
1
Description
Landry restoration index
Timepoint
2, 4, 7, 14, and 30 days after surgery
Method of measurement
by Landry, Turnbull and Howley index
2
Description
Pain Visual Analogue scale
Timepoint
2, 4, 7, 14, and 30 day after surgery
Method of measurement
by Visual Analogue Scale
3
Description
Manchester restoration index
Timepoint
2, 4, 7, 14, and 30 days after surgery
Method of measurement
by Manchester index
Secondary outcomes
empty
Intervention groups
1
Description
Control group: gingival graft surgery with mucous adhesive
Category
Treatment - Surgery
2
Description
Intervention group: gingival graft surgery with mucous adhesive nifedipine
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral Medicine departmet of Babol dental faculty
Full name of responsible person
Mohaddeseh Emampanahi
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3228 9046
Email
M.emampanahi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina Motallebnejad
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4717647745
Phone
+98 11 3228 9046
Email
Mmotallebnejad@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Mina Motallebnejad
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4716686468
Phone
+98 11 3228 9046
Email
Mmotallebnejad@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mina Motallebnejad
Position
full professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4716686468
Phone
+98 11 3228 9046
Email
Mmotallebnejad@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mohaddeseh Emampanahi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Ganjafrooz Ave.
City
Babol
Province
Mazandaran
Postal code
4716686468
Phone
+98 11 3228 9046
Email
M.emampanahi@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