Radiographic evaluation of crestal bone resorption with 2 types of graft material ( Ceno bone and Cera bone ) and without graft material in immediate placement of the implant in the central area to the second maxillary premolar
Design
Randomized, controlled clinical trial with 2 parallel group desgn of 45 implant sites. For randomization ( coin toss) will be divided into three groups (n=15) based on the type of graft material.
Settings and conduct
Clinical trial will be performed on patients referred to the periodontology department of the School of Dentistry of Babol University of Medical Sciences.
The procedure will be performed according to the standard systems designed for Dio implants (Korea).
Participants/Inclusion and exclusion criteria
Inclusion criteria: age over 18 years old; need for tooth extraction; oral health; proper bone quality; sufficient bone height; the presence of sufficient residual alveolar bone; presence of at least 3 mm of keratinized tissue.
Exclusion criteria: smoking; uncontrolled diabetes; poor oral hygiene; pregnant women; need for bone augmentation; receiving corticosteroids; consumption of bisphosphates; untreated periodontal disease; existence of bone defects; malocclusion; unacceptable occlusion; coagulation problems; use of alcohol; abscesses and fistules
Intervention groups
In the control group no grafting material is used in the gap between the fixture and the bone. In the second group xenograft material cerabone (Cerabone, Botiss, Germany) is used in the gap between the fixture and the bone. In the third group allograft material under the brand name cenobone (Hamanand saze baft kish, iran) is used in the gap between the fixture and the bone.
Main outcome variables
Crestal bone resorption
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220521054954N1
Registration date:2022-07-03, 1401/04/12
Registration timing:registered_while_recruiting
Last update:2022-07-03, 1401/04/12
Update count:0
Registration date
2022-07-03, 1401/04/12
Registrant information
Name
Sahar Cheperli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3333 1579
Email address
sahar.cheperlii1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-07-06, 1401/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic evaluation of crestal bone resorption with and without graft material in the maxillary fresh socket implantation
Public title
Evaluation of crestal bone resorption in the maxillary fresh socket implantation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years old
Need for tooth extraction in the central to second maxillary premolars for traumatic, endodontic or prosthetic reasons
oral health ( plaque index below 20%)
The bone quality in the implant areas in the range of type ll and lll bone density
Existence of appropriate bone height in the interradicular area after tooth extraction and proper bone width for implant Placement with a minimum length of 10 mm and a diameter of at least 3.5 mm
The sufficient residual alveolar bone to achieve the primary stability of the implant
Presence of at least 3 mm of keratinized tissue
Exclusion criteria:
smoking
uncontrolled diabetes
poor oral hygiene
pegnant women
need for bone augmentation
long-term use of NSAIDs
oral or intravenous treatment of bisphosphonates
receiving corticosteroids and conditions affecting bone metabolism
untreated periodontal disease
existence of bone defects
malocclusion
unacceptable occlusion caused by teeth overgrowth or teeth tilting toward edentulous area
severe parafunctional habits
coagulation problems
use of alcohol
abscesses and fistules and lesions that have caused perforation of the buccal and palatal bone
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Province
Mazandaran
Postal code
47148-95498
Approval date
2022-04-24, 1401/02/04
Ethics committee reference number
IR.MUBABOL.REC.1401.033
Health conditions studied
1
Description of health condition studied
Radiographic evaluation of crestal bone resorption in areas with non-maintenance teeth and immediate implant placement
ICD-10 code
M27.6
ICD-10 code description
Endosseous dental implant failure
Primary outcomes
1
Description
Crestal bone resorption
Timepoint
One week after surgery, one month, three months and six months later
Method of measurement
Parallel periapical radiography under standard conditions
Secondary outcomes
empty
Intervention groups
1
Description
Control group: No graft material is used.
Category
N/A
2
Description
Intervention group: َAllograft material Ceno bone (Hamanandsaze baft kish, iran)
Category
N/A
3
Description
Intervention group: Xenograft material cera bone (Cerabone, Botiss, Germany)
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol University of Medical Sciences, Periodontology department
Full name of responsible person
Nilufar Jenabian
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3225 0824
Fax
+98 11 3225 0803
Email
Niloofarjenabian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mahdi rajabnia
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3225 0824
Fax
+98 11 3225 0803
Email
research@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Nilufar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3225 0824
Fax
+98 11 3225 0803
Email
sahar.cheperlii1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nilufar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
0098 11 3225082
Fax
+98 11 3225 0803
Email
sahar.cheperlii1991@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Nilufar Jenabian
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganjafrooz st.
City
Babol
Province
Mazandaran
Postal code
47176-47745
Phone
+98 11 3225 0824
Fax
+98 11 3225 0803
Email
sahar.cheperlii1991@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
Some of the data include preoperative and postoperative measurements
When the data will become available and for how long
The access period starts one year after the results are published
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
Approved by the project manager
From where data/document is obtainable
Resident
Sahar.cheperlii1991@gmailo.com
What processes are involved for a request to access data/document