Radiographic comparison of the effect of using DFDBA alone and with hyaluronic acid gel in the treatment of socket preservation: A randomized clinical trial
Design
Randomized, clinical trial, triple blinded, 10 patients each have at least two non-molar non-adjacent teeth.
Settings and conduct
Study is conducted at Shiraz Dental School. Initial CBCT is reviewed. The flap is reflected, the tooth is removed by the periotome with minimal damage. In half of the cases, the cavity will filled with DFDBA and others with DFDBA and a 1% hyaluronic acid gel and both are coated with collagen membranes. The flap is repositioned and sutured to cover the membrane. After 4 months, new CBCTs are taken and analyzed for width and height changes. Patients are not aware of the type of treatment they receive. The assignment of patients in each group is done by a third person, the surgeon is not aware of the type of substance that is available to him, and the radiologist is not aware of which groups of data are being studied.
Participants/Inclusion and exclusion criteria
Patients who require tooth extraction other than molar teeth to replace with implant and have CBCT at initial visit. Patients should be at least 18 years of age, have adequate oral hygiene and be able to attend surgical procedures.
Exclusion criteria are pregnancy, lactation, medications or diseases that interfere with bone metabolism (Paget), osteoporosis, history of head and neck radiotherapy, uncontrolled diabetes, and smoking.
The teeth sockets should have all the walls before extraction and do not have dehiscence more than 3 mm at the time of surgery. Also, adjacent teeth should not be restored with amalgam or metal crown.
Intervention groups
Use of hyaluronic acid gel in socket preservation
Main outcome variables
Height and width of the dental socket before and after the surgery in control and test groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190120042431N1
Registration date:2019-02-16, 1397/11/27
Registration timing:prospective
Last update:2019-02-16, 1397/11/27
Update count:0
Registration date
2019-02-16, 1397/11/27
Registrant information
Name
pardis haddadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3229 3028
Email address
haddadi.p@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Radiographic comparison of DFDBA alone and in combination with hyaluronic acid gel in socket preservation: Randomized clinical trial.
Public title
Hyaluronic acid effect on socket preservation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who need tooth extraction other than molar teeth to replace with implant.
All patients must be at least 18 years of age.
Have proper oral hygiene.
Can participate in surgical programs.
Have CBCT on first visit.
Exclusion criteria:
Pregnancy
Lactation
Medications, or diseases that interfered with bone metabolism (Paget), osteoporosis
History of head and neck radiotherapy
Uncontrolled diabetes
Long-term use of NSAIDs
Steroid-therapy
Smoking.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
non-adjacent non-molar tooth
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization. This is done by using a random number table. A table row and column are chosen randomly and the point of their intersection will be the beginning of sampling. control group samples are selected by moving the row to the right. The rest of the numbers will be in the test group
Blinding (investigator's opinion)
Triple blinded
Blinding description
The patient, the physician and the data analyst, do not know which tooth is in the test group and which is in the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, 7th floor, central building of the Shiraz Medical School, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7194696434
Approval date
2017-11-22, 1396/09/01
Ethics committee reference number
IR.SUMS.REC.1396.151
Health conditions studied
1
Description of health condition studied
tooth loss
ICD-10 code
K08.1
ICD-10 code description
Loss of teeth due to accident, extraction or local periodontal disease
Primary outcomes
1
Description
Height and width of the alveolar bone in extracted area
Timepoint
4 months
Method of measurement
Comparing the before and after CBCT image
Secondary outcomes
empty
Intervention groups
1
Description
In each area, the tissue flaps will be reflected to expose bone plates, teeth will be extracted with minimal trauma to the hard and soft tissues. Sockets will be curetted and washed with normal saline to remove all the soft tissues. In each patient, randomly, one of the extraction sockets will fill with DFDBA powder which is an allograft material, and the other one fill with DFDBA powder plus 1% hyaluronic acid gel. Both sockets will be covered with an absorbable alloderm membrane so that the membrane covers at least 3 mm over the alveolar crest. Flaps will then be replaced and sutured with 3-0 vicryl interrupted and mattress sutures.