The aim of this study is to evaluate the acellular dermal matrix zinc oxide nanoparticle loaded as a novel membrane in socket preservation technique, clinically and radiographically by CBCT.
Design
Randomized clinical trial with control group, parallel, double blind
Settings and conduct
This study is an ۴-month a double blind Randomized Controlled Clinical Trial performing on ۲۲ patients referring to the Periodontology department of Shiraz Dental School, requiring extraction of a single root tooth. Patients are allocated in a ۱:۱ ratio to either using ADM (control group) or ZnO nanoparticle loaded ADM (test group). Bone graft will be used in both groups. Clinical and radiographic (CBCT) measurements will be performed at baseline and after ۴ months.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Age ≥ ۱۸ years
Adequate restorative space for implant-retained restoration
Presence of all ۵ walls of the socket
At least ۱۰ mm alveolar bone height without impingement on the maxillary sinus or mandibular canal
Presence of one mesial and one distal tooth.
Exclusion criteria:
Presence of periodontal disease
Smoking
History of systemic diseases that contraindicate oral surgery
Long-term non-steroidal anti-inflammatory drug therapy
Bisphosphonate therapy
Pregnancy or lactation
Absence of vestibular or lingual socket wall
Intervention groups
test group: ZnONPs loaded ADM
control group: ADM
these membranes will be placed on extraction sockets during surgery
Main outcome variables
Clinical evaluation
• Vestibular bone thickness (VBT)
• Ridge width (RW)
• The heights of the vestibular and lingual crest (HVC-HLC)
Radiographic CBCT evaluation:
The horizontal ridge width(HW-۱, HW-۳, HW-۵).
The thickness of the buccal bone plate is measured only at baseline (BBP-۱, BBP-۳, BBP-۵).
The height of the socket walls is calculated at the midbuccal (BH) and midlingual (LH)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211224053505N1
Registration date:2022-02-19, 1400/11/30
Registration timing:registered_while_recruiting
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Zahra Rastegar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3628
Email address
zahrarastegar@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-14, 1400/11/25
Expected recruitment end date
2022-07-16, 1401/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Acellular dermal matrix loaded with zinc oxide nanoparticles as a new membrane in extraction socket preservation technique: a clinical and CBCT study
Public title
Title : Acellular dermal matrix loaded with zinc oxide nanoparticles as a new membrane in extraction socket preservation technique: a clinical and CBCT study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥ ۱۸ years
Adequate restorative space for implant-retained restoration
Presence of all ۵ walls of the socket
At least ۱۰ mm alveolar bone height without impingement on the maxillary sinus or mandibular canal
Presence of one mesial and one distal tooth.
Exclusion criteria:
Presence of periodontal disease
smoking
History of systemic diseases that contraindicate oral surgery
Long-term non-steroidal anti-inflammatory drug therapy
Bisphosphonate therapy
Pregnancy or lactation
Absence of vestibular or lingual socket wall
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
22
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation in test and control groups will be randomly
assigned to each patient by computer-generated
random number table. The randomization codes will be
stored in password-protected portable computers and
enclosed in sequentially numbered, identical, opaque,
sealed envelopes. The envelopes will be opened in
numerical order after tooth extraction.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double blind randomized clinical trial. Randomization and patient allocation to each group will be done by a third person not
involved in the other parts of the research.The resident, involved in the project, will perform the ESP surgeries.
All pre- and postoperative clinical assessments will be done by a single, masked examiner who is not the operating surgeon and is blind to the groups. Training and calibration for measuring of CBCT criteria are conducted prior to the study to ensure intra and inter examiner reproducibility of the measured outcomes. Radiolographic data will be measured by a radiologist specialist and the resident.
The patients are also blind in relation to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Dental school, Ghasrdasht Street,
City
shiraz
Province
Fars
Postal code
7195615878
Approval date
2021-11-03, 1400/08/12
Ethics committee reference number
IR.SUMS.DENTAL.REC.1400.100
Health conditions studied
1
Description of health condition studied
Extraction Socket preservation
ICD-10 code
K05.6
ICD-10 code description
Periodontal disease, unspecified
Primary outcomes
1
Description
Clinical evaluation: After tooth extraction: 1.Vestibular bone thickness (VBT), is measured with a surgical caliper ۲ mm below the residual alveolar bone margin to the nearest ۰.۵ mm
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months.
Method of measurement
by caliper and periodontal probe
2
Description
Clinical evaluation: After tooth extraction: Ridge width (RW) is measured at the midfacial level of the buccal bone plate using a surgical caliper ۲ mm from the crest of the ridge to the nearest ۰.۵ mm.
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months.
Method of measurement
by caliper and periodontal probe
3
Description
Clinical evaluation: After tooth extraction: The heights of the vestibular and lingual crest (HVC-HLC) is measured by using a periodontal probe to connect the midfacial CEJs of the adjacent teeth, then measuring the vertical distance from that reference line to the crest of bone on the midfacial and midlingual sides.
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months.
Method of measurement
by caliper and periodontal probe
4
Description
Radiographic evaluation: Linear measurements are made on the CBCT images: The horizontal ridge width is calculated at three horizontal lines (۱ mm, ۳ mm, and ۵ mm apical to the most coronal aspect of the crest) perpendicular to a vertical reference line drawn in the center of the extraction socket and crossing its most apical point at baseline (HW-۱, HW-۳, HW-۵)
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months
Method of measurement
by Cone Beam Computed Tomography (CBCT)
5
Description
Radiographic evaluation: Linear measurements are made on the CBCT images: The thickness of the buccal bone plate is measured only at baseline on the same levels apical to the lingual bone crest (BBP-۱, BBP-۳, BBP-۵)
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months
Method of measurement
by Cone Beam Computed Tomography (CBCT)
6
Description
Radiographic evaluation: Linear measurements are made on the CBCT images: The height of the socket walls is calculated at the midbuccal (BH) and midlingual (LH).
Timepoint
At the baseline before performing the extraction socket preservation technique and then after 4 months
Method of measurement
by Cone Beam Computed Tomography (CBCT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: test group: ZnO Nano Particles loaded Acellular Dermal Matrix, Human skin specimen will be obtained from abdominal plastic surgeries performed in Department of Plastic Surgery, Shiraz University of Medical Sciences. The tissue samples are kept in phosphate buffer saline (PBS: Sigma Aldrich, USA), while penicillin-streptomycin (Sigma Aldrich, USA) and fungisone (Sigma Aldrich, USA) are also added. The skin samples are cut into pieces using a sterile blade and the remained tissue is kept at -۲۰ºC until use. After ۳ times washing with PBS, subdermal fat tissue and hair are excised, NaCl, Triton X۱۰۰ and EDTA solution are used for removal of epidermis. The washing solution is identical using ۰.۵%Triton X۱۰۰ and ۱۰mMEDTA for ۲ times. The ADM, then is incorporated with Zno nanoparticles ۳%.
Category
Treatment - Surgery
2
Description
Control group: Acellular Dermal Matrix manufactored by Regen company
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shiraz university of medical sciences, Dental school, Periodontology department
Full name of responsible person
ّّFarin Kiany Yazdi
Street address
Dental school, Ghasrdasht Street
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
farinkiany@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mahtab Memarpour
Street address
Dental school, Ghasrdasht Street,
City
shiraz
Province
Fars
Postal code
15878- 71956
Phone
+98 71 3626 3193
Email
memarpour@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farin Kiany Yazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghasrdasht Street
City
Shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3626 3193
Email
farinkiany@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farin Kiany Yazdi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghasrdasht Street
City
Shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3626 3193
Email
farinkiany@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Zahra Rastegar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental school, Ghasrdasht Street
City
Shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3626 3193
Email
zahrarastegar@sums.ac.ir
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