Comparison of short-term effects (3 months, case group) and long-term (4 months, control group)of HA/β-TCP on new bone formation; following tooth extraction.
Design
After removing of the teeth, after a debridement and complete washing, the bone graft is hydrated for 10 minutes with sterile saline and then placed in the tooth socket. The socket is sutured with nylon 5-0 thread. Then patients are scheduled to be sampled. After 3 or 4 months sampling is done by Trephine bur. The sample is placed in a neutral 10% formaldehyde buffering solution and sent to the laboratory for data collection.
Settings and conduct
This research is done at the Faculty of Dentistry, Islamic Azad University, Tehran. After removing tooth, the HA/β-TCP is placed in the tooth socket and then the suture is done by nylon 5-0 thread.
Patients are called up after 3 or 4 months, depending on the group they are in. Bone samples are taken from the target area and sent to the laboratory for data collection.
Participants/Inclusion and exclusion criteria
Patient inclusion criteria:single-rooted teeth needing extraction.
patient desiring restoration with a dental implant.
adequate space for restoration.
Exclusion criteria: patients not fulfilling inclusion criteria or not compliant with necessary procedural follow-up
pregnancy
active systemic/local infection not including periodontitis
medical conditions or medications known to alter soft tissue or bony healing (poorly controlled diabetes mellitus [DM], bisphosphonates, immunosuppressives, etc.Teeth with short roots or roots that were malpositioned such that the core biopsy might include bone along the socket wall.
Intervention groups
Tooth extraction is performed on all people entering the study.
Main outcome variables
New bone formation; residual graft; connective tissue and inflammation after 3 months and 4 months
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040460N2
Registration date:2018-12-26, 1397/10/05
Registration timing:retrospective
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-22, 1396/07/30
Expected recruitment end date
2018-11-15, 1397/08/24
Actual recruitment start date
2017-10-22, 1396/07/30
Actual recruitment end date
2018-11-15, 1397/08/24
Trial completion date
empty
Scientific title
Effect of healing time on new bone formation after tooth extraction with HA/β-TCP
Public title
Effect of HA/β-TCP on new bone formation after tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-rooted teeth needing extraction
Patient desiring restoration with a dental implant
Adequate space for restoration
Exclusion criteria:
Patients not fulfilling inclusion criteria or not compliant with necessary procedural follow-up
Pregnancy
Active systemic/local infection not including periodontitis
Medical conditions or medications known to alter soft tissue or bony healing (poorly controlled diabetes mellitus [DM], bisphosphonates, immunosuppressives, etc.)
Teeth with short roots or roots that were malpositioned such that the core biopsy might include bone along the socket wall. Females of childbearing age without tubal ligation, menopause, or hysterectomy were required to have a negative pregnancy test prior to surgery.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Dividing the samples completely randomly into two groups of case and control by dropping the coin and dividing it into two groups of 3 months (case) and 4 months (control) and hiding the card until the patients were re-referenced.
Blinding (investigator's opinion)
Double blinded
Blinding description
All individuals involved in this research, such as clinicians, outcome evaluators, data analyzers, safety committees, and data monitoring, have been unaware of the randomization process of samples, and only researchers and therapists in this study have compared the time Sampling and referral of patients are well known.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Dentistry Islamic Azad University, Tehran Branch
Street address
Tehran, Pasdaran Street, Ninth Neyestan Avenue
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396,15
Health conditions studied
1
Description of health condition studied
Evaluation of bone formation with HA/β-TCP after tooth extraction
ICD-10 code
K08.2
ICD-10 code description
Atrophy of edentulous alveolar ridge
Primary outcomes
1
Description
The amount of Bone Formation
Timepoint
3 months and 4 months
Method of measurement
Calculated by optical microscope
2
Description
Amount of Residual graft
Timepoint
3 months and 4 months
Method of measurement
Calculated by optical microscope
3
Description
Amount of Connective Tissue and Inflammation Rate
Timepoint
3 months and 4 months
Method of measurement
Calculated by optical microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group includes 20 dental samples need to be extracted and required Implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (3 months) and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns.
Category
Treatment - Surgery
2
Description
Control group: This group includes 20 dental samples need to be extracted and required implant treatment. The dental socket (after tooth extraction) is filled with OSTEON, from Dentium company, Korea, and its entry is covered with Collagen from brand called Auto Plug. The specimens are randomly divided into this group (4 months) , and after the prescribed time, they are called for sampling. The bone sample is taken to examine the condition of the bone and is delivered to the Pathology Laboratory. The OSTEON is an 70% TCP Synthetic Bone Graft material with 30% Hydroxyapatite coated on it. The powder contains particles of 500-1000 microns.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Islamic Azad University of Tehran
Full name of responsible person
Nima Nadaf pour
Street address
Tehran, Pasdaran Street, Ninth Neyestan Avenue
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
zm.mosalmani1993@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Arash Azizi
Street address
Tehran, Pasdaran Street, Ninth Neyestan Avenue
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
zm.mosalmani1993@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nima Nadaf Pour
Position
Periodontics professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran, Pasdaran Street , Ninth Neyestan avenue
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
n_nadaf@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima nadaf Pour
Position
Periodontics Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tehran , Pasdaran street , Ninth Neyestan avenue
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
n_nadaf@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Mosalmani
Position
Dental student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tehran , Pasdaran street , Ninth Neyestan avenue
City
Tehran
Province
Tehran
Postal code
1415773511
Phone
+98 21 8898 4370
Email
zm.mosalmani1993@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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Comparison of short-term effects (3 months, case group) and long-term (4 months, control group) Application of synthetic HA / β-TCP on histopathology of bone formation following tooth extraction in patients referring to the dental unit of Islamic Azad University of Tehran in 1396-1397 .
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
All people who need data
Under which criteria data/document could be used
Analyzes that do not damage the outcome of our data analysis are allowed.
From where data/document is obtainable
Faculty of Dentistry Islamic Azad University of Tehran
What processes are involved for a request to access data/document
Visit the Faculty of Dentistry, Islamic Azad University of Tehran and request there, and will access the data within 1 week.