Comparison of Effects between Short-term (3 months, Intervention group) and Long-term (4 months, Control group) of FDBA Allograft on New Bone Formation after Tooth Extraction.
Design
After extraction of the teeth, after a Debridement and complete washing, the
Bone graft material is hydrated for 10 minutes with Sterile Saline and then placed in 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 will be 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 FDBA 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 patients 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:IRCT20170419033535N4
Registration date:2019-01-05, 1397/10/15
Registration timing:retrospective
Last update:2019-01-05, 1397/10/15
Update count:0
Registration date
2019-01-05, 1397/10/15
Registrant information
Name
omid moghaddas
Name of organization / entity
islamic azad unicersity dental of teh
Country
Iran (Islamic Republic of)
Phone
+98 912 277 6280
Email address
o_moghaddas@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
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Healing Time on New Bone Formation after Tooth Extraction with Freeze-Dried Bone Allograft
Public title
Effect of Freeze-Dried Bone Allograft on new bone formation after tooth extraction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Single-rooted teeth needing extraction
Patient desiring restoration with Dental implant
Adequate space for Restoration
Exclusion criteria:
Patients not fulfilling inclusion criteria or not compliant with necessary procedural follow-up
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.
Pregnancy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
More than 1 sample in each individual
Actual sample size in each individual:
0
Randomization (investigator's opinion)
Randomized
Randomization description
Dividing the samples completely randomly into two groups of 3 months (Intervention group) and 4 months (Control group) by dropping the coin and hiding the card until the patients were recalled.
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 of Tehran
Evaluation of bone formation with FDBA 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
The amount of Residual Graft
Timepoint
3 months and 4 months
Method of measurement
Calculated by Optical Microscope
3
Description
The 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 FDBA, from Hamanand Saz Baft Kish company, Iran, 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. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material.
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 FDBA, from Hamanand Saz Baft Kish company, Iran, 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. FDBA (Freeze-Dried bone Allograft) is an Allograft material that is obtained by Minerilizing the cortical bone of the same species, and freezing and drying it. In 1976, FDBA entered periodontal treatments and was considered as an Osteoconductive material.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry Islamic Azad University of Tehran
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, intervention group) and long-term effects (4 months, control group) of FDBA application on Histopathology of bone formation following tooth extraction in patients referring to 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 results
To whom data/document is available
All people who need data can apply for them.
Under which criteria data/document could be used
Analyzes that do not harm our data.
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.