clinical and radiographic evaluation of dental implant system Avita
Design
This study is a phase 2 clinical trial study .76 implants will be studied and patients will be admitted to the study voluntarily and non-randomly from individuals over 18 years of age.
Settings and conduct
This study will be conducted in Implant Research Center Tehran University of Medical Science. Avita implant will be inserted in the proper location and chlorhexidine 0.2% and Gelofen 400 mg will be prescribed for patients. Immediately after surgery and 3 month later( before prosthesis delivery) implant's stability will be assessed by Ostell mentor.Clinical evaluation(including pocket depth,plaque index, bleeding on probing and presence of Pus) will be done in 3,6 and 12 month post surgery. One week after surgery(after suture removal), 3, 6 and 12 months later parallel periapcal radiography will be taken. Finally radiography will be evaluated for mesial and distal bone resorption by radiologist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patient over 18 years; single edentulous or 3 unit bridge; 1 mm bone around implant
exclusion criteria: 1/need of augmentation around implant; 2/presence pus; 3/ heavy smoker; 4/ uncontrolled diabetes or another diseases;
Intervention groups
Avita implant with proper size with 1 millimeter bone around implant will be used.
Main outcome variables
pocket probing depth; bleeding on probing; plaque index; bone loss; Implant stability
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210802052053N1
Registration date:2021-10-18, 1400/07/26
Registration timing:prospective
Last update:2021-10-18, 1400/07/26
Update count:0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Mohadeseh Heidari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8351
Email address
heidarim@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-22, 1400/07/30
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of bone loss in patients treated with Iranian implant Avita who referred to Dental Implant Research Center: An uncontrolled clinical trial
Public title
evaluation of dental implant Avita
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single edentulous or short 3-unit bridge
The presence of one millimeter bone around the implant
Exclusion criteria:
the need of augmentation in implant region
presence of pus in implant region
heavy smoker
uncontrolled diabetes or any diseases
using bisphosphonate
active periodontal disease
bruxism and clenching
pregnancy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
76
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical sciences
Street address
Faculty of Dentistry, North Kargar Ave, Enghelab square
City
Tehran
Province
Tehran
Postal code
1439955991
Approval date
2021-10-09, 1400/07/17
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1400.144
Health conditions studied
1
Description of health condition studied
Single edentulous or three-unit bridge
ICD-10 code
K08.1
ICD-10 code description
Complete loss of teeth
Primary outcomes
1
Description
bone loss
Timepoint
Immediately, 3,6 and 12 month after surgery
Method of measurement
periapical radiography
Secondary outcomes
1
Description
pocket depth
Timepoint
3,6 and 12 months after surgery
Method of measurement
periodontal probe
2
Description
bleeding on probing
Timepoint
3,6 and 12 months after surgery
Method of measurement
periodontal probe
3
Description
plaque index
Timepoint
3,6 and 12 months after surgery
Method of measurement
periodontal probe
4
Description
implant stability
Timepoint
Immediately, 3 months after surgery( before prosthetics delivery)
Method of measurement
Implant stability measuring device (Osstell)
Intervention groups
1
Description
Intervention group: Iranian dental implant system Avita
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental implant research center
Full name of responsible person
Mohadeseh Heidari
Street address
Dental Research Institute, Tehran university of medical sciences, ghods St, Enghelab Av, Tehran
City
Tehran
Province
Tehran
Postal code
1981613441
Phone
+98 21 8897 8351
Email
heidarim@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamidreza Barikani
Street address
Dental Research Institute, Tehran university of medical sciences, ghods St, Enghelab Av, Tehran
City
Tehran
Province
Tehran
Postal code
1981613441
Phone
+98 21 8897 8351
Email
hrBarikani@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohadeseh Heidari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Research Institute, Tehran university of medical sciences, ghods St, Enghelab Av, Tehran
City
Tehran
Province
Tehran
Postal code
1981613441
Phone
+98 21 8897 8351
Email
heidarim@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohadeh Hiedari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental Research Institute, Tehran university of medical sciences, ghods St, Enghelab Av, Tehran
City
Tehran
Province
Tehran
Postal code
1981613441
Phone
+98 21 8897 8351
Email
heidarim@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazal Jabalameli
Position
Dentist
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dental Research Institute, Tehran university of medical sciences, ghods St, Enghelab Av, Tehran
City
Tehran
Province
Tehran
Postal code
1981613441
Phone
+98 21 8897 8351
Email
ameli.ghazal@gmail.com
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