Comparative Evaluation of the effect of platelet rich fibrin and acellular dermal matrix on soft tissue thickness in patients receiving dental implants
Comparison of the effect of platelet rich fibrin and acellular dermal matrix on soft tissue thickness in patients receiving dental implants
Design
Two arm parallel group randomized trial with blinded outcome assessment and data analysis
Settings and conduct
The study will be run in Dentistry faculty of Mashhad University of Medical Sciences. After receiving informed consent, a blind calibrated examiner will measure the tissue thickness. Measurements will be repeated after 3 months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient who need dental implants in posterior mandible with thin gingival biotype.
Exclusion criteria: any medical contraindication for dental implants; need for soft tissue or hard tissue augmentation.
Intervention groups
Platelet rich fibrin and acellular dermal matrix will be used for soft tissue thickening in intervention and control group, respectively.
Main outcome variables
Soft tissue thickness in the area of implant placement
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200914048713N1
Registration date:2021-11-30, 1400/09/09
Registration timing:prospective
Last update:2021-11-30, 1400/09/09
Update count:0
Registration date
2021-11-30, 1400/09/09
Registrant information
Name
moein khojaste
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 8832 2300
Email address
khojastehm981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-05, 1400/10/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of the effect of platelet rich fibrin and acellular dermal matrix on soft tissue thickness in patients receiving dental implants
Public title
Effect of platelet rich fibrin on soft tissue thickness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient who need dental implants in posterior mandible
Less than 2 mm soft tissue thickness
Adequate width and height of the bone
healthy soft tissue
Lack of previous hard tissue augmentation
Lack of previous soft tissue augmentation
Exclusion criteria:
Age less than 18 and more than 60 years old
Medical contraindication for dental implants
Untreated periodontitis
Uncontrolled diabetes mellitus
Smokers and alcoholic patients
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using "randomization.com" website. All data will be placed in opaque sealed envelop and will be opened by nurse before surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who measures soft tissue thickness at baseline and follow up is totally blind to the type of intervention. Person who analyzes the data is also blind. blinding of the patients and the surgeon is not possible.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil abad street, vest door of ferdowsi university, faculty of dentistry
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.081
Health conditions studied
1
Description of health condition studied
Thin soft tissue
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Soft tissue thickness
Timepoint
Baseline, 3 months postoperative
Method of measurement
Endodontic reamer, gauge with 0.1 mm accuracy
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 layers of platelet rich fibrin will be placed under soft tissue before suturing.
Category
Treatment - Other
2
Description
Control group: An acellular dermis membrane with 0.6-1 mm thickness will be placed under patients soft tissue before suturing.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad Dental School
Full name of responsible person
Amir Moeen Taghavi
Street address
Faculty of dentistry, West door of Ferdowsi University, Vakil Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3882 9501
Email
RAMResearch@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Hossein Bagheri
Street address
Faculty of dentistry, West door of Ferdowsi University, Vakil Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3806 7278
Email
RAMResearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
ِAmir Moeein Taghavi
Position
profrssor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, West door of Ferdowsi University, Vakil Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3806 7278
Email
moeentaghavia@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farid Shiezadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, West door of Ferdowsi University, Vakil Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3806 7278
Email
fshd1365@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Moein Khojasteh
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, West door of Ferdowsi University, Vakil Abad street
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3806 7278
Email
moein.khojaste@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
Necessary information will be sent to the journal that publishes the article.