Radiological and histological evaluation of collagen membrane fixation with tack and suturing, and suturing alone in horizontal alveolar ridge augmentation: A Randomized Clinical Trial
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
44
44
empty
2020-04-02, 1399/01/14
2020-04-02 00:00:00
empty
2021-11-05, 1400/08/14
2021-11-05 00:00:00
empty
2021-12-15, 1400/09/24
2021-12-15 00:00:00
empty
This study is prospective, but it is registered retrospective, please check it. The recruitment start date was 02/04/2020 and the recruitment end date was 05/11/2021
This study is prospective, but it is registered retrospective, please check it. The recruitment start date was 02/04/2020 and the recruitment end date was 05/11/2021
empty
این مطالعه به صورت آینده نگر انجام شده است ولی به صورت گذشته نگر ثبت شده است لطفا چک کنین. تاریخ شروع بیمارگیری 02/04/2020 و تاریخ خاتمه بیمارگیری 05/11/2021 می باشد
این مطالعه به صورت آینده نگر انجام شده است ولی به صورت گذشته نگر ثبت شده است لطفا چک کنین. تاریخ شروع بیمارگیری 02/04/2020 و تاریخ خاتمه بیمارگیری 05/11/2021 می باشد
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. hashemi pour
Full name of responsible person - Persian: دکتر هاشمی پور
Street address - English: Kosar blvd.
Street address - Persian: بلوار کوثر
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7618759689
Phone: +98 34 3211 9021
Fax:
Email: mmohammadi28@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Hashemi pour
Full name of responsible person - Persian: دکتر هاشمی پور
Street address - English: Kosar blvd.
Street address - Persian: بلوار کوثر
City - English: Kerman
City - Persian: کرمان
Province: Kerman
Country: Iran (Islamic Republic of)
Postal code: 7618759689
Phone: +98 34 3211 9021
Fax:
Email: mmohammadi28@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. hashemiHashemi pour Full name of responsible person - Persian: دکتر هاشمی پور Street address - English: Kosar blvd. Street address - Persian: بلوار کوثر City - English: Kerman City - Persian: کرمان Province: Kerman Country: Iran (Islamic Republic of) Postal code: 7618759689 Phone: +98 34 3211 9021 Fax: Email: mmohammadi28@yahoo.com Web page address:
Protocol summary
Study aim
Histological and radiological comparison of collagen membrane fixation with tack and suturing, and suturing alone in horizontal alveolar ridge augmentation.
Design
This study is a parallel, single-blind randomized controlled clinical trial that will enroll 40 patients. The patients will be selected by non-probable simple random sampling (available sample). The samples will be randomly divided into two groups; membrane fixation with tack and suturing and membrane fixation with suturing alone.
Settings and conduct
The study population are patients who needed horizontal bone augmentation for implant treatment and referred to the KMU Dental School.
The study will be performed as a single blind study.
Preoperative measurements include measuring the width of the ridge at 0, 2, 4 and 6 mm distances from the Crest through CBCT.
6 months after bone augmentation, the ridge width will be reassessed at same areas as previously measured and compared with preoperative dimensions.
Histologic specimens from both groups will be compared in terms of mineralized tissue by light microscopy.
All radiographical and histological measurements will be will be done by clinicians who are blind to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: need to horizontal augmentation of alvolar bone for implant (edentulous ridge width: 2/5 - 4 mm and in B-W group). Plaque index and bleeding index less than 20 percent.
Exclusion criteria: contraindications for implant treatment (use of more than 10 cigarettes per day; pregnancy; non controlled periodontal diseases; use of bisphosphonate and corticosteroid; chemotherapy and radiotherapy; systematic diseases for example: uncontrolled diabetes and immune deficiency)
Intervention groups
Group 1: collagen membrane fixation with tack and suturing
Group 2: collagen membrane fixation with suturing alone
Main outcome variables
width of the ridge
General information
Reason for update
This study is prospective, but it is registered retrospective, please check it. The recruitment start date was 02/04/2020 and the recruitment end date was 05/11/2021
Acronym
IRCT registration information
IRCT registration number:IRCT20101204005305N19
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2023-09-01, 1402/06/10
Update count:1
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Mohammad Mohammadi
Name of organization / entity
Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 9021
Email address
m_mohammadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-11, 1398/06/20
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
2020-04-02, 1399/01/14
Actual recruitment end date
2021-11-05, 1400/08/14
Trial completion date
2021-12-15, 1400/09/24
Scientific title
Radiological and histological evaluation of collagen membrane fixation with tack and suturing, and suturing alone in horizontal alveolar ridge augmentation: A Randomized Clinical Trial
Public title
evaluation of collagen membrane fixation with tack and suturing, and suturing alone in alveolar ridge augmentation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
need to horizontal augmentation of alvolar bone for implant
edentulous ridge width: 2/5-4 mm
plaque index and bleeding index less than 20 percent.
Exclusion criteria:
use of more than 10 cigarettes per day
pregnancy
uncontrolled periodontal diseases
use of bisphosphonate and corticosteroid
chemotherapy and radiotherapy
systematic diseases for example: uncontrolled diabetes; osteoporosis and immune deficiency
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done using a coin toss and participants will be divided into intervention and control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Two clinicians who are calibrated and blind to the study will perform all radiographic measurements. The demographic data of all radiographies will be removed and a code will be given to each radiography. A pathologist who is blind to the study will assess the prepared slides. For blindness, a code will be given to each slides.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman Medical Sciences University
Street address
Tahmasbabad Crossover, Researches Center
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2019-08-25, 1398/06/03
Ethics committee reference number
IR.KMU.REC.1398.250
Health conditions studied
1
Description of health condition studied
Bone loss
ICD-10 code
M85.8
ICD-10 code description
Other specified disorders of bone density and structure
Primary outcomes
1
Description
Alveolar Ridge Width
Timepoint
6 month After bone augmentation
Method of measurement
By CBCT
Secondary outcomes
1
Description
Histology of new formed bone
Timepoint
6 months after alveolar ridge augmentation
Method of measurement
Observation with optical microscope
Intervention groups
1
Description
Intervention group: collagen membrane fixation with tack and suturing after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran) and tack. Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second surgery.
Category
Treatment - Surgery
2
Description
Control group: collagen membrane fixation with suturing alone after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran). Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Department, Kerman Dental School
Full name of responsible person
ِDr. Mohammad Mohammadi
Street address
Shafa street, Dental school
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
mmohammadi28@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Hashemi pour
Street address
Kosar blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
mmohammadi28@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
mohammad mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontics Department, Kerman Dental School, Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1211 9021
Fax
Email
mmohammadi28@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontics Department, Kerman Dental School, Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1211 9021
Fax
Email
mmohammadi28@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Periodontics Department, Kerman Dental School, Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 1211 9021
Fax
Email
mmohammadi28@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available