The purpose of this study is to investigate the use of phenytoin in filling the dead space between the gingival former of the implant fixture and regenerating the periodontal tissue around the implant.
Design
A controlled, crossover, blinded, randomized, phase 3 clinical trial on 90 samples. A table of random numbers was used for randomization.
Settings and conduct
Patients who received implant surgical treatment and were referred to the prosthodontist's office along with the gingiva former are included in the study. All these patients received a brand of implant. Each patient is prepared for impression. A parallel periapical radiography prepared and inside the implant fixture will be rinsed with normal saline. The apicocoronally mucosa height will measure by William's probe. The impression steps are followed. Before closing the healing abutment, the patients are randomly divided into two control and test groups. In the test group, the threaded part of the healing abutment is smeared with phenytoin ointment and then it will be closed with proper torque. But in the control group, the healing abutment is not smeared with medicine.
1 month after the first visit, the patients are called. Patients do not know whether phenytoin was applied to the implant or not.
Participants/Inclusion and exclusion criteria
Patients who received implant surgical treatment and were referred to the private dental office of a prosthodontist along with the gingival former are included in the study.
Intervention groups
After impression and before closing the healing abutment, in the patients of the test group, the threaded part of the healing abutment is smeared with phenytoin ointment and then closed with the appropriate torque.
Main outcome variables
The average height and thickness of the gingiva in the control and test groups will be compared before and one month after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211124053173N2
Registration date:2024-05-05, 1403/02/16
Registration timing:prospective
Last update:2024-05-05, 1403/02/16
Update count:0
Registration date
2024-05-05, 1403/02/16
Registrant information
Name
Kamran Lahoorpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3535 3535
Email address
drkamranor2@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the use of 1% phenytoin ointment on peri-implant mucosa
Public title
Using 1% phenytoin ointment on the mucosa around the implant
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with one or more dental implants that reached to the impression stage
One type of dental implant system has been used for all patients
Exclusion criteria:
Smokers
People with a history of any systemic condition such as diabetes, etc,
Pregnancy
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
More than 1 sample in each individual
Number of samples in each individual:
4
Each patient can have more than one implant in his\her mouth, and each implant is considered as one sample.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients referring to the specialist dental prosthesis office are included in the study based on inclusion criteria. Each patient may have one or more dental implants. Each implant is considered as a sample. Samples are randomly assigned to two groups, control and test, using simple randomization with a random number table method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Each patient may have one or more dental implants. Each implant is considered as a sample. In the test group, the gingiva former is coated with phenytoin ointment out of the patient's view, while in the control group, no ointment is used. The patient is unaware of the presence or absence of the drug on the gingiva former.
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 Street
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2024-03-12, 1402/12/22
Ethics committee reference number
IR.MUK.REC.1402.265
Health conditions studied
1
Description of health condition studied
Examining the dimensions of the gingiva around the dental implant after using phenytoin ointment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measures peri-implant gingival changes after using phenytoin
Timepoint
The measurement is before and one month after the intervention.
Method of measurement
Using a periodontal probe, the height and thickness of the gingiva are measured in millimeters.
Secondary outcomes
empty
Intervention groups
1
Description
patients receiving dental implants who came for impression and after impression were taken, in the test group, the threaded part of the gingiva former is smeared with 1% phenytoin ointment (Medipharm Company, Kish, Iran) and then will be closed with proper torque.
Category
Treatment - Drugs
2
Description
Control group: Patients receiving dental implants who came for impression and after impression were taken, the gingival former will be closed with appropriate torque.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Private office of Dr. Kamran Lahoorpoor
Full name of responsible person
Kamran Lahoorpoor
Street address
Molvi St
City
Sannandaj
Province
Kurdistan
Postal code
6616653987
Phone
+98 918 808 8869
Email
drkamranor2@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
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 87 3366 4653
Email
drkamranor2@gmail.com
Grant name
Grant code / Reference number
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
Rojin Sarhadi
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 937 007 6950
Email
sarhaddirozhin@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Sarhadi
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 937 007 6950
Email
sarhaddirozhin@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Rojin Sarhadi
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blvd
City
Sanandaj
Province
Kurdistan
Postal code
6618634683
Phone
+98 937 007 6950
Email
sarhaddirozhin@gmail.com
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 potentially shareable after unidentified individuals.
When the data will become available and for how long
Access starts after Publishing the results.
To whom data/document is available
Researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Researchers have access to the data under any circumstances.
From where data/document is obtainable
For more information, you can contact the corresponding author via the following email: drkamranor2@gmail.com
What processes are involved for a request to access data/document
The applicant has unlimited access to the data after sending the request via email to the corresponding author.