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comparison between AlloDerm and Amniotic membrane as covering material for healing post operative wounds in Clark Vestibuloplasty

Protocol summary

Summary
Subjects , referred from Department of Prosthodontics, will be recruited for this study. informed consent, approved by research ethical board of Mashhad University of Medical Science, will be signed by each patient prior to surgical procedure. The inclination of the anterior wall of the mandible body will be assessed by lateral cephalogram. In addition, panoramic radiography will be used for alveolar bone height evaluation. Firstly, the labial vestibular depth was increased 1 centimeter by scrapping the cast. Next, considering the inclination of the anterior wall of the body of the mandible, the splint was created, finished and polished. Two hours prior to the vestibuloplasty, all subjects will received preoperative dose of 2 g amoxicillin orally and continued to take 0.5 g of antibiotics three times daily for 7 days. After receiving local anesthesia of 2% lidocaine plus 1/100000 epinephrine, a flap will be released from underlying periosteum via a horizontal incision through mucogingival border, extending from right to left premolar area. The flap was then apically positioned 10 mm and will be sutured with 4-0 silk to the periosteum. In each patient the right and left exposed periosteum will be covered by Cryopreserved Human Amniotic Membrane (AM) and acellular dermal matrix (ADM) respectively. The splint, will be lined with soft liner to establish minimal dead space creation, fixed with two bone screws. After removal of the splint and the fixation screws on postoperative day 7, all participants will be followed up after 7 days, 2 weeks, 4 weeks to assess vestibular depth. specimen will be obtained from graft margins for evaluating CD31 and CD68 positive cells migration. All data will be analysed by SPSS 18 software. In this study, subjects, surgeon, examiner, and data analyser will be blinded to the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082835160N1
Registration date: 2017-08-28, 1396/06/06
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Mahdi Gholami
Name of organization / entity
Mashhad University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 51 3884 0736
Email address
gholamimh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad university of Medical Science
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison between AlloDerm and Amniotic membrane as covering material for healing post operative wounds in Clark Vestibuloplasty
Public title
Effect of alloderm and amniotic membrane as covering materials for healing oral wounds.
Purpose
Treatment
Inclusion/Exclusion criteria
1. Complete Edentulism in lower jaw. 2. Alveolar bone resorption in mandible 3. Having at least 2 mm of residual bone in lower jaw
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization will be performed by coin flip

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Science
Street address
Azadi Square- Dentistry Faculty
City
Mashhad
Postal code
Approval date
2017-05-17, 1396/02/27
Ethics committee reference number
IR.mums.sd.rec1394.225

Health conditions studied

1

Description of health condition studied
resorbed mandible alveolar bone in edentulous patient
ICD-10 code
K06.9
ICD-10 code description
Disorder of gingiva and edentulous alveolar ridge, unspecified

Primary outcomes

1

Description
Cell Migration
Timepoint
3 and 7 days following end of treatment
Method of measurement
Flow cytometry

2

Description
Vestibule depth
Timepoint
pre treatment, 1 week, 2 weeks, 4 weeks, and 3 months following end of treatment
Method of measurement
with calliper with graduation of 0.1 millimetres

Secondary outcomes

1

Description
Pain
Timepoint
1 week following the end of treatment
Method of measurement
Oral questionnaire

2

Description
Local infection
Timepoint
1 week following the end of treatment
Method of measurement
Clinical assessment

Intervention groups

1

Description
use of amniotic membrane as graft material for covering denuded periosteum after vestibuloplasty using Clark's technique
Category
Treatment - Surgery

2

Description
use of acellular dermal matrix as graft material for covering denuded periosteum after vestibuloplasty using Clark's technique
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry Faculty- Dental and Oral prosthodontics Department
Full name of responsible person
Danial Babaki
Street address
Azadi square
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputy of Mashhad University of Medical Science
Full name of responsible person
Mahdi Gholami
Street address
Daneshgah Street-
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Mashhad University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Dentistry Faculty- Mashhad university of medical science
Full name of responsible person
Danial Babaki
Position
Dentistry Student and M.Sc student of cell and molecular biology
Other areas of specialty/work
Street address
Azadi square
City
Mashhad
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
dnlbabaki@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dentistry Faculty- Mashhad University of Medical Science
Full name of responsible person
Mahdi Gholami
Position
Oral and Maxillofacial Surgeon/ Assistant Professor
Other areas of specialty/work
Street address
Azadi square
City
Mashhad
Postal code
9177948959
Phone
+98 518829501
Fax
+98 51 3882 9500
Email
Gholamimh@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dentistry Faculty- Mashhad University of Medical Science
Full name of responsible person
Danial Babaki
Position
Dentistry student and M.Sc. student of cell and molecular biology
Other areas of specialty/work
Street address
Azadi square
City
Mashhad
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
Dnlbabaki@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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