Determining the clinical and histological effect of collagen membrane and acellular dermal matrix in increasing the vertical thickness of soft tissue on implants in patients referred to the implant department of Islamic Azad University of Tehran
Design
A single-blind clinical trial is performed and 24 eligible patients are performed in one center
Settings and conduct
The study will be performed clinically and histologically in Tehran Azad Dental School and the clinician and pathologist will be unaware of the grouping and the grouping will be done by the researcher
Participants/Inclusion and exclusion criteria
Inclusion criteria: tissue thickness in vertical dimension (2 mm or less), healthy soft tissue, partial edentulous of posterior of jaws, presence of at least 4 mm keratinized tissue
Exclusion criteria: bone agmentation process , O 'LEARY plaque control index more than 20%, smoking, presence of systemic disease, use of drugs ,pregnancy
Intervention groups
Collagen membrane group
Acellular Dermal Matrix (ADM) group
Main outcome variables
Soft tissue thickness, Amount of collagen, Inflammation rate, Vascular density
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210510051251N1
Registration date:2021-11-21, 1400/08/30
Registration timing:registered_while_recruiting
Last update:2021-11-21, 1400/08/30
Update count:0
Registration date
2021-11-21, 1400/08/30
Registrant information
Name
meysam sanginan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8828 5796
Email address
sanginan.m@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-12, 1400/07/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and histological comparison of collagen membrane and acellular dermal matrix in peri_implant vertical soft tissue thickening
Public title
Comparison of collagen and dermal matrix in soft tissue thickening
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Thin vertical sot tissue thickness(less than 2 mm)
4 mm keratinized tissue at least
Partial edentulus in posterior of jaws
Healthy soft tissue
Exclusion criteria:
Need to bone augmentation procedure
O’ LEARY plaque index more than 20%
Tobacco consumption
Systemic disease related to soft & hard tissue healing
Drug consumption related to soft & hard tissue healing
Pregnancy
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in 6-blocks pattern in such a way that three blocks belong to the collagen membrane group (CM) and three blocks belong to the acellular dermal matrix group (ADM). Each sample is assigned to a group by tossing a coin. Find that the valve belongs to the CM group and the line belongs to the ADM group. This process is performed 4 times until finally 24 patients are included in the study
Blinding (investigator's opinion)
Single blinded
Blinding description
Evaluators of results and data analysts are uninformed from the study groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Dentistry, Tehran Azad University of Medical Sciences
Street address
9th Neystan Ave., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2020-05-09, 1399/02/20
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.019
Health conditions studied
1
Description of health condition studied
Thin peri-implant soft tissue thickness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Soft tissue thickness
Timepoint
Base line, 2 months
Method of measurement
The thickness of the soft tissue in the center of the implant will be measured with a UNC periodontal probe (Hu-Friedy, USA) relying on the lingual flap
2
Description
Amount of collagen
Timepoint
Base line, 2 months
Method of measurement
The biopsy specimens will be placed in paraffin blocks after fixation and microscopic incisions 3-4 mm thick will be prepared. The prepared sections will then be stained with Masson trichrom to evaluate the amount of collagen
3
Description
Inflammation rate
Timepoint
Base line, 2 months
Method of measurement
Biopsy specimens are stained with hematoxylin-eosin to measure the severity of inflammation and will be classified to mild, moderate, and severe
4
Description
Vascular density
Timepoint
Base line, 2 months
Method of measurement
Immunohistochemical staining with CD34 monoclonal antibody prepared from mice will be used to evaluate blood vessels
Secondary outcomes
empty
Intervention groups
1
Description
Collagen membrane group: The membranes are 15 x 20 mm in size and are shaped according to the implant site to prevent the adjacent teeth from invading and to adapt to the newly placed implant. The membrane expands 5 mm at the buccal surface and 5 mm at the lingual surface to better fit the area and complete implant coverage. Once the membrane is in place, the flaps will be brought closer together and sutured with 0-5 nylon thread (Supa, Iran) using the Single Interrupted technique.
Category
Treatment - Surgery
2
Description
Acellular group of dermal matrix: The matrixs are 15 x 20 mm in size and are shaped according to the implant site to prevent the adjacent teeth from invading and to adapt to the newly placed implant. The membrane expands 5 mm at the buccal surface and 5 mm at the lingual surface to better fit the area and complete implant coverage. Once the membrane is in place, the flaps will be brought closer together and sutured with 0-5 nylon thread (Supa, Iran) using the Single Interrupted technique.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Islamic Azad University of Tehran
Full name of responsible person
Meysam Sanginan
Street address
9th Neystan AVE., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 8828 5796
Email
sanginan.m@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Islamic Azad University of Tehran
Street address
9th Neystan AVE., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8828 5796
Email
sanginan.m@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Tehran
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Nima Nadafpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neystan AVE., pasdaran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2245 4571
Email
nima.na04@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Meysam Sanginan
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
9th Neystan AVE., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 8828 5796
Email
sanginan.m@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Nima Nadafpour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
9th Neystan AVE., Pasdaran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
nima.na04@gmail.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
There is no more information
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