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Effect of different implant placement depths on crestal bone thickness of the implant area

Protocol summary

Study aim
Evaluation of different implant placement depths on the crestal bone levels the implant area
Design
A clinical trial with the control group, parallel groups, without blinding (split-mouth, cross over), non-randomize
Settings and conduct
This study will be performed in the implant ward of Mashhad Dental School with a split-mouth design, which means that there was an intervention and control group in a patient's mouth. if the patient will need two implants, one will place subcrestal (3 mm below the bone crest) and one will place at the level of the bone crest.
Participants/Inclusion and exclusion criteria
Inclusion criteria: In terms of physical condition, according to the American Society of Anesthesiologists (ASA), ASA I or ASA II; informed consent; Patients older than 18 years; patients who need to place 2 or 3 implants; no general contraindications (low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, and liver disorders); No lesions and malignancies at the surgical site; No smoking. Exclusion criteria: occurring medical problems during surgery, patient refusing to follow-up session.
Intervention groups
The study design will be split mouth. In the control group, the implant will place at bone crestal level, and in the control group, the implant will place at 3 mm subcrestal level of bone.
Main outcome variables
crestal bone levels immediately, 3 months and 6 months after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038558N2
Registration date: 2022-02-15, 1400/11/26
Registration timing: prospective

Last update: 2022-02-15, 1400/11/26
Update count: 0
Registration date
2022-02-15, 1400/11/26
Registrant information
Name
Naser Sargolzaie
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3602 5063
Email address
sargolzaien@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of different implant placement depths on crestal bone thickness of the implant area
Public title
Effect of different implant placement depths on crestal bone thickness of the implant area
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
American Society of Anesthesiologists (ASA) physical status classification system, patient should be ASA I or ASA II (normal healthy patient or patient with mild systemic disease) Patient with informed consent. Need to place 2 or 3 implants No general contraindications (patients with low blood pressure, bradycardia, sinus disorder, unstable high blood pressure, and liver disorders.) No lesions and malignancies at the surgical site; No smoking. Patients older than 18 years
Exclusion criteria:
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 25
More than 1 sample in each individual
Number of samples in each individual: 2
dental implant placement at subcrestal and equicrestal
Randomization (investigator's opinion)
Not randomized
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 Mashhad University of Medical Sciences
Street address
Central Building of Mashhad University of Medical Sciences, University Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9187811111
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.MUMS.DENTISTRY.REC.1400.036

Health conditions studied

1

Description of health condition studied
edentulous alveolar ridge
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge

2

Description of health condition studied
Dental implant
ICD-10 code
Z96.5
ICD-10 code description
Presence of tooth-root and mandibular implants

Primary outcomes

1

Description
the level of implant crestal bone
Timepoint
Immediately, 3 months and 6 months after surgery
Method of measurement
Digital periapical radiography

Secondary outcomes

empty

Intervention groups

1

Description
Control group: After anesthesia injection, a crystal incision will be done the tissue. the flap will be removed with the help of periosteal elevator. After the bone drilling, The bone-level implant will be placed in the crestal level of bone with the two-stages protocol.
Category
Treatment - Other

2

Description
Intervention group: After anesthesia injection, a crystal incision will be done the tissue. the flap will be removed with the help of periosteal elevator. After the bone drilling, The bone-level implant will be placed at 3 mm below the bone crest with two-stages protocol.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad dental school
Full name of responsible person
Naser Sargolzaie
Street address
Mashhad Dental School, Vakilabad St., Mashhad
City
Mashad
Province
Razavi Khorasan
Postal code
9187811111
Phone
+98 51 3602 5063
Email
sargolzaien@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayyur Mobarehan
Street address
Deputy of Research and Technology, Ghorashi Building, University Street, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
+98 51 3843 0249
Email
vcresraech@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No85 , West hamed 8
City
Mashad
Province
Razavi Khorasan
Postal code
9187811111
Phone
+98 51 3602 5063
Email
sargolzaien@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No85 , West hamed 8
City
Mashad
Province
Razavi Khorasan
Postal code
9187811111
Phone
+98 51 3602 5063
Email
sargolzaien@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Naser Sargolzaie
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No85 , West hamed 8
City
Mashad
Province
Razavi Khorasan
Postal code
9187811111
Phone
+98 51 3602 5063
Email
sargolzaien@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data would be shared for all researchers after the participants were unidentified.
When the data will become available and for how long
The access to data will be started 6 months after publication
To whom data/document is available
The data would only be available for people working in academic institutions.
Under which criteria data/document could be used
It is allowed to use the data for meta-analysis and systematic reviews.
From where data/document is obtainable
The data can be obtained via email, from the corresponding researcher
What processes are involved for a request to access data/document
The new research proposal and the process details should be e-mailed to the corresponding researcher in order to get the access permission
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