Plain English Summary
Background and study aims
Dental implants are artificial replacements for tooth roots that are placed within the bone of the jaw so that they can be used to support dentures, crowns (caps) or bridges.
In some patients there is not enough bone in their jaw to allow dental implants to be inserted. In cases where a lot of bone is needed, it may be possible to rebuild the jaw using bone taken from another part of the body. DentoGen® is a new bone graft product that can be used in place of bone.
The aim of this study is to evaluate the efficacy of using calcium sulfate bone graft (bone substitute with commercial name DentoGen®).
Who can participate?
Patients aged 25 – 65 years with tooth loss in the anterior area of the maxilla extracted at least 3 months before the study.
What does the study involve?
Patients undergo dental implant surgery as normal using the bone substitute material in place of a usual bone graft. Patients are followed up after four months.
What are the possible benefits and risks of participating?
The possible benefits are to gain bone in the buccal side of the dental implants so that means we could achieve one stage implantation with GBR by a new method using a reliable material allowing us to:
1. Dispense the use of collagen membrane and titanium mesh
2. Reduce the overall treatment plan time in these cases from nearly a year to just 4 months
3. Give the ability to treat the patient with bone loos by dental implant without expose them for more than 1 surgery.
The possible risk is to not having a perfect bone remodelling on the margin of the buccal side of the implant which will slightly effect the aesthetic side of the area
Where is the study run from?
Faculty of Dentistry of Damascus University (Syria)
When is the study starting and how long is it expected to run for?
June 2019 to May 2020
Who is funding the study?
Damascus University (Syria)
Who is the main contact?
Kenan Saoud, kenan.saoud@outlook.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kenan Saoud
ORCID ID
http://orcid.org/0000-0002-6146-9756
Contact details
Damascus University
Mazzeh Highway
Damascus
-
Syria
+963 966600565
kenan.saoud@outlook.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Nil known
Study information
Scientific title
Evaluation of the effectiveness of using calcium sulfate bone graft in the context of immediate grafting around dental implants
Acronym
Study hypothesis
Calcium sulfate from (DentoGen ®) is effective as a bone grafting material
Ethics approval
Approved 14/05/2019, Scientific research committee in the faculty of dentistry at Damascus University (Mazzeh Highway, Damascus, Syria; +963113341864; manager@hcsr.gov.sy), ref: 557
Study design
Prospective interventional study
Primary study design
Interventional
Secondary study design
Prospective interventional study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Bone grafting in the buccal side of dental implants when the bone is thin
Intervention
After local anesthesia a full-thickness flap is made in the implantation site, the best place of the implant in point and axes is determined, a very thin layer of bone is left buccally after socket preparation then the implant is inserted then the graft (CS) is mixed and the buccal bone layer dried by Gauze, after that apply the material on the buccal side by layers and making pressure on it by Gauze moisturizer with the combined solution waiting 2 - 4 minutes until the graft is solid then make sure that the flap can be sutured free of tension to make a firm closure using 4-0 nylon sutures.
Next day a CBCT image is taken of the implantation area, measured to determine the width of the site, the amount of the gain, graft and bone density.
The sutures are removed 8 - 10 days after the surgery.
After 4 months the final CBCT image is taken to do the same measurements and compare it with the previous ones to determine the final width of the site, the amount of the gain, graft and bone density and the resorption rate of the graft.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
Using CBCT imaging technique:
1. Width of the bone in the grafted area the day after the procedure and at 4 months
2. Bone and graft density buccally to the implants the day after application and after 4 months
3. Resorption rate of the graft by comparing measures taken the day after and 4 months after
Secondary outcome measures
1. Width in the site of implantation the day after the procedure and at 4 months using CBCT imaging technique
2. The thickness of attached gingiva in the area of implantation before the procedure and 4 months after using CBCT imaging technique
3. The success rate at 4 months (further surgery required, yes or no)
Overall trial start date
14/05/2019
Overall trial end date
01/05/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patient with tooth loss in the anterior area of the maxilla extracted at least 3 months before the study.
2. Healthy patient with no general diseases and no medication intake.
3. Aged 25 - 65 years
4. Width of the alveolar ridge 3.5 - 5.5 mm on a diagnostic CBCT image
5. Non smoking
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
12
Participant exclusion criteria
1. Newly extracted teeth in the area of tooth lost
2. General diseases or medication intake
3. Bad oral hygiene or smoking
Recruitment start date
17/06/2019
Recruitment end date
05/11/2019
Locations
Countries of recruitment
Syria
Trial participating centre
Damascus University
Faculty of Dentistry
Mazzeh Highway
Damascus
-
Syria
Sponsor information
Organisation
Damascus University
Sponsor details
Mazzeh Highway
Damascus
-
Syria
+963 (0)114442727
info@damascusuniversity.edu.sy
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Damascus University
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
01/09/2020
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list