- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04131894
Effects of Autogenous Dentin Graft on Socket Preservation
October 16, 2019 updated by: Ezgi Yüceer Çetiner, Bahçeşehir University
Healing of Extraction Sockets Preserved With Autogenous Dentin Graft: A Clinical, Histological, Histomorphometrical and Electron Microscobic Study
Various graft materials are used to reconstruct bone defects in the jaws due to tooth loss, trauma, advanced periodontal diseases, pathological lesions and congenital disorders.
The main features of an ideal bone graft are osteogenesis, osteoinduction and osteoconduction.
Autogenous bone graft is considered as the gold standard among all bone graft materials.
Because it has all the features that an ideal bone graft should have.
However, there are some disadvantages such as donor site morbidity, obtaining limited amounts and high rates of resorption.
Because of these disadvantages, other bone graft materials such as allografts, xenografts and alloplastic bone grafts are frequently used for bone augmentation.
In the light of recent studies, the limits of conventional bone graft materials such as limited osteoconduction capacity and disease transmission have been clearly demonstrated.
Due to the disadvantages of these materials, studies are directed to develop alternative graft materials.
Aim of this study is to analyse the effects of autogenous dentin graft and mixture of autogenous dentin graft and platelet rich fibrin (PRF) applied to the tooth extraction sockets on bone healing process.
A total of 57 extraction sockets in 9 patients who were planned to be treated with dental implant after tooth extraction were evaluated in this study.
Extraction sockets were divided randomly into 3 groups.
In the first group, sockets were filled with autogenous dentin graft (Group D-20 sockets).
In the second group, sockets were filled with the mixture of PRF and autogenous dentin graft (Group DP-21 sockets).
In the third group, sockets were left empty as control group (Group C-16 sockets).
After 3 months, histological and immunohistochemical evaluations were performed on the samples taken during the implant surgery.
Additionally, samples obtained from each group were examined by scanning electron microscopy (SEM).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age≥18 years,
- Systemically healthy patients (ASA I and II),
- Adequate restorative space for implant-retained restoration.
Exclusion Criteria:
- Teeth with deep decay or root canal filling,
- Systemically complicated patients (ASA III, IV, V),
- Presence of acute infection,
- Pregnancy or lactation,
- Unwillingness to return for the follow-up periods
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: Control
Extraction sockets with spontaneous healing (16 sockets).
|
|
ACTIVE_COMPARATOR: Dentin
Extraction sockets were filled with undemineralized autogenous dentin graft (20 sockets).
|
|
ACTIVE_COMPARATOR: Dentin+PRF
Extraction sockets were filled with mixture of undemineralized autogenous dentin graft and platelet rich fibrin (PRF) (21 sockets).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histopathological Evaluation
Time Frame: 3 months after the augmentation procedure
|
Samples obtained from the groups were fixed in 10% formalin solution and decalcified in 5% formic acid solution.
The samples were gradually dehydrated in an ethanol series, placed in xylene for clearing, and then embedded in paraffin.
The tissue blocks were sectioned at 5µm on a rotary microtome (Leica RM 2125RT, Nussloch, Germany).
Sections were stored overnight at 60°C for deparaffinization.
Then the deparaffinization process was completed with xylene series.
Following this procedure, the sections were passed from the alcohol series and dehydrated.
Following deparaffinization, all sections were stained using Hematoxylin-Eosin staining method.
Five sections were taken from each sample and used for histopathological evaluation.
Images were taken from all sections in X4, X10 and X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment.
New bone, connective tissue, graft and blood vessel volumes were evaluated by histopathological scoring method.
|
3 months after the augmentation procedure
|
Immunohistochemical Evaluation
Time Frame: 3 months after the augmentation procedure
|
Sections (5 µm) were taken from each sample and deparafinization was completed.
Mouse and Rabbit Specific HRP / AEC (ABC) Detection IHC Kit (Abcam, USA) was used to perform the reactions.
After this process, the sections were exposed until color change in order to show the immune reaction in the tissue and counterstained briefly with Mayer's hematoxylin.
Anti-BMP-2 and anti-RUNX-2 antibodies (Abcam, USA) were used.
Finally, the sections were washed with distilled water and then covered with immune closure medium.
Images were taken in X4, X10, X20 magnification using light microscope (Olympus BX43, Center Valley, PA) with camera attachment (Carl Zeiss, Germany).
|
3 months after the augmentation procedure
|
Scanning Electron Microscopy (SEM) Evaluation
Time Frame: 3 months after the augmentation procedure
|
After the drying process, 4 samples from each group were coated with a 10 nm thick gold-palladium layer using the coating device (Balzers-SCd 050, Germany).
The samples were analyzed at 10 kV with the SEM device (JSM-7001 F, JEOL, Tokyo, Japan) for the purpose of examining the surface formation.
For each group, the image was taken at X2000, X5000 and X10.000 magnification.
|
3 months after the augmentation procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
December 5, 2016
Primary Completion (ACTUAL)
April 30, 2018
Study Completion (ACTUAL)
August 27, 2018
Study Registration Dates
First Submitted
October 15, 2019
First Submitted That Met QC Criteria
October 16, 2019
First Posted (ACTUAL)
October 18, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 18, 2019
Last Update Submitted That Met QC Criteria
October 16, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 71146310 [2015-AC-CE-42]
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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