Bone Quality AssessmentEarly Phase 1NCT05771038
Assessment of Bone Quality After Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone
A Early Phase 1 study testing socket preservation using sodium alendronate gel and socket preservation using sticky bone in people with Bone Quality Assessment and Preserved Sockets, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of study to evaluate the quality and quantity of the formed bone after socket preservation using sticky bone versus alendronate gel Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Quality Assessment, Preserved Sockets, Sodium Alendronate
- What is being tested?
- socket preservation using sodium alendronate gel and socket preservation using sticky bone
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- Apr 2023to Jul 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- defective class III sockets
- Patients with non-restorable teeth extracted sites
- Patients who have given their consent for this trial.
- Both genders males and females will be included.
Who cannot join
- Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
- Subjected to irradiation in the head and neck area less than 1 year before implantation.
- Patients having history of allergy to any drugs.
- Patients who have a history of any concomitant major known medical problem and/or ongoing pharmacologic treatments
- Untreated periodontitis.
- Poor oral hygiene and motivation.
Show all 17Show fewer
- Uncontrolled diabetes.
- Pregnant or nursing.
- Substance abuse.
- Psychiatric problems or unrealistic expectations.
- Severe bruxism or clenching.
- Immunosuppressed or immunocompromised.
- Treated or under treatment with intravenous amino-bisphosphonates.
- Active infection or severe inflammation in the area intended for implant placement.
- Unable to open mouth sufficiently to accommodate the surgical tooling.
- Patients participating in other studies, if the present protocol could not be properly followed.
- Referred only for implant placement or unable to attend a 5-year follow-up.
Trial locations and contacts
1 site in 1 country.
mohammed omara contact
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo
aya elgohary, 00201100122225, aya.elgohary@dentistry.cu.edu.eg
About this study
Official title: Assessment of Bone Quality After Defective Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone : A Histomorphometric Randomized Clinical Controlled Trial
The aim of study to evaluate the quality and quantity of the formed bone after socket preservation using sticky bone versus alendronate gel
Read the detailed description
this study is alternative hypothesis research based on that one technique will be more efficient and effective than the other. In our case, the bone produced after introducing the sodium alendronate drug in defective sockets will be beneficial and will have better density and histomorphological features than treating the socket with sticky bone technique .
Several socket preservation techniques with different regenerative biomaterials and procedures as bone grafts, membranes, biological modifiers and platelet concentrates were introduced in the literature to overcome these problems.
Some researchers tried to introduce alternative techniques to preserve the socket depending on the enhancement of the native physiological mechanism of bone formation without the need for grafting through utilization of chemical agents that interfere with bone resorption, among these agents are the Bisphosphonates. Bisphosphonates are originally used in diseases with increased bone resorption as osteoporosis, paget's and fibrous dysplasia, hypercalcemia of malignancies.
The Effect of local delivery of alendronate on bone resorption following mucoperiosteal flap in mandible of rats was examined in Oxford Dental College Hospital, Bomannahalli on patients between 30 to 65 years old .and they found that alendronate reduces the resorptive activity of alveolar ridge significantly. It was found that local alendronate reduces active bone resorption without interfering with bone mineralization and quality. On remodeling surfaces local bisphosphonates binds to apatite crystals inhibiting their growth, aggregation and dissolution. As a result it decreases the turnover rate and increasing the mass and strength of bone.
Many authors as Jakobsen in 2009, supports the results from a study That found that the local Bisphosphonate (alendronate) treatment gives good bone quality and quantity.
So this study is conducted to evaluate the difference in bone quality and quantity produced on sockets preserved using sticky bone and local sodium alendronate compared to no intervention sockets.
Explanation for choice of comparators:
The main issue in traumatic Salama class 3 defective maxillary anterior sockets is the decreased amount of bone, sticky bone socket preservation technique needs venesection and it needs second surgical site adding more office time .on the other hand using sodium alendronate decreases the turnover rate and increasing the mass and strength of bone without the need of second surgical site or bone grafting material.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A pre-operative CBCT will be done to evaluate the height and the width of the intended alveolar ridge
Intra operative procedures for the study groups:
This clinical report describes Three different groups Following the protocol of The Oxford Dental College Hospital, Bomannahalli.
In all groups :
Infiltration anesthesia or nerve block according the socket were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Scrubbing and draping of the patient was carried out in a standard fashion using betadine , atraumatic extraction will then be done.
- In first group: 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket.
- In second group: prepared sodium alendronate gel will be placed in defective extraction sockets.
Follow up
Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation.
After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed.
- Being tested
- socket preservation using sodium alendronate gel, socket preservation using sticky bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
socket preservation using sodium alendronate gelProcedure or surgery
sockets will be preserved by sodium alendronate gel before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation.
After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed
socket preservation using sticky boneProcedure or surgery
sockets will be preserved by sticky bone as mentioned before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation.
After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed
| Study group | Role | What they receive |
|---|---|---|
| sodium alendronate group | Active comparator | prepared sodium alendronate gel will be placed in defective extraction sockets. Receives: Procedure: socket preservation using sodium alendronate gel |
| stickybone group | Active comparator | 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket. Receives: Procedure: socket preservation using sticky bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histomorphometric analysis
bone sample will be taken and bone quality will be assesed
Measured: 3 month from the socket preservation procedure
Secondary outcomes (2)
Bone density
Bone density will be measured on CBCT
Measured: 3 month
alveolar crest bone height
alveolar crest bone height will be measured on CBCT
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study startApr 2023 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone Quality AssessmentStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * In first group: 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket. * In second group: prepared sodium alendronate gel will be placed in defective extraction sockets.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Reda Hamed Elgohary, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05771038
- Sponsor's protocol ID
- sodiumalendronate ,stickybone
- Status last verified
- Mar 2023
- First submitted
- 22 Dec 2022
- Last updated
- 16 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saulacic N, Munoz F, Kobayashi E, Chappuis V, Gonzales-Cantalapiedra A, Hofstetter W. Effects of local application of alendronate on early healing of extraction socket in dogs. Clin Oral Investig. 2020 Apr;24(4):1579-1589. doi: 10.1007/s00784-019-03031-7. Epub 2019 Jul 26.
PubMed 31346723
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Bone Quality After Defective Socket Preservation Using Sodium Alendronate Gel Compared to Sticky Bone : A Histomorphometric Randomized Clinical Controlled Trial
- ClinicalTrials.gov ID
- NCT05771038
- Acronym / sponsor ID
- sodiumalendronate ,stickybone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2023 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of study to evaluate the quality and quantity of the formed bone after socket preservation using sticky bone versus alendronate gel
Detailed description
this study is alternative hypothesis research based on that one technique will be more efficient and effective than the other. In our case, the bone produced after introducing the sodium alendronate drug in defective sockets will be beneficial and will have better density and histomorphological features than treating the socket with sticky bone technique .
Several socket preservation techniques with different regenerative biomaterials and procedures as bone grafts, membranes, biological modifiers and platelet concentrates were introduced in the literature to overcome these problems.
Some researchers tried to introduce alternative techniques to preserve the socket depending on the enhancement of the native physiological mechanism of bone formation without the need for grafting through utilization of chemical agents that interfere with bone resorption, among these agents are the Bisphosphonates. Bisphosphonates are originally used in diseases with increased bone resorption as osteoporosis, paget's and fibrous dysplasia, hypercalcemia of malignancies.
The Effect of local delivery of alendronate on bone resorption following mucoperiosteal flap in mandible of rats was examined in Oxford Dental College Hospital, Bomannahalli on patients between 30 to 65 years old .and they found that alendronate reduces the resorptive activity of alveolar ridge significantly. It was found that local alendronate reduces active bone resorption without interfering with bone mineralization and quality. On remodeling surfaces local bisphosphonates binds to apatite crystals inhibiting their growth, aggregation and dissolution. As a result it decreases the turnover rate and increasing the mass and strength of bone.
Many authors as Jakobsen in 2009, supports the results from a study That found that the local Bisphosphonate (alendronate) treatment gives good bone quality and quantity.
So this study is conducted to evaluate the difference in bone quality and quantity produced on sockets preserved using sticky bone and local sodium alendronate compared to no intervention sockets.
Explanation for choice of comparators:
The main issue in traumatic Salama class 3 defective maxillary anterior sockets is the decreased amount of bone, sticky bone socket preservation technique needs venesection and it needs second surgical site adding more office time .on the other hand using sodium alendronate decreases the turnover rate and increasing the mass and strength of bone without the need of second surgical site or bone grafting material.
Clinical evaluation:
A through medical and dental history followed by clinical examination was carried out for all patients. Clinical measurements were taken to ensure patient adherence to our initial inclusion criteria prior to further investigations.
A pre-operative CBCT will be done to evaluate the height and the width of the intended alveolar ridge
Intra operative procedures for the study groups:
This clinical report describes Three different groups Following the protocol of The Oxford Dental College Hospital, Bomannahalli.
In all groups :
Infiltration anesthesia or nerve block according the socket were administered using mepivacaine HCl (2%) with levonordefrin 1:20 000 (Scandonest 2%; Septodont, Saint- Maur-des-Fossés, France). Injection to control pain and bleeding for hemostasis. Scrubbing and draping of the patient was carried out in a standard fashion using betadine , atraumatic extraction will then be done.
- In first group: 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket.
- In second group: prepared sodium alendronate gel will be placed in defective extraction sockets.
Follow up
Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation.
After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- * In first group: 20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket. * In second group: prepared sodium alendronate gel will be placed in defective extraction sockets.
| Arm | Type | Receives |
|---|---|---|
| sodium alendronate group | Active comparator | Procedure: socket preservation using sodium alendronate gelprepared sodium alendronate gel will be placed in defective extraction sockets. |
| stickybone group | Active comparator | Procedure: socket preservation using sticky bone20cc of venous blood is collected from the patient's forearm into silica-coated tube (10 ml) and 1 non coated vacutainer. Blood will be used to make injectable prf by spinning in centrifuge(2400-2700) for 2 minutes to produce autologous fibrin glue and then for 12 minutes+/- 2 minutes to obtain the concentrated growth factor layer. and sticky bone will be prepared then inserted into the socket. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- defective class III sockets
- Patients with non-restorable teeth extracted sites
- Patients who have given their consent for this trial.
- Both genders males and females will be included.
Key exclusion criteria (17 listed)
- Patients should not have taken drugs, especially bisphosphonates or drugs altering bone metabolism, within 2 months before the inclusion in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| socket preservation using sodium alendronate gelsockets will be preserved by sodium alendronate gel before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation. After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed | Procedure or surgery | sodium alendronate group |
| socket preservation using sticky bonesockets will be preserved by sticky bone as mentioned before then Patients will be evaluated after 3 days and weekly thereafter for the first month and then once monthly for signs of soft tissue irritation. After 3 months post-operative CBCT scans will be done to evaluate the bone density, alveolar crest bone height will be measured and core biopsy will be taken for Histomorphological study at the same visit where implant will be placed | Procedure or surgery | stickybone group |
Primary outcome
Histomorphometric analysis
Time frame: 3 month from the socket preservation procedure
bone sample will be taken and bone quality will be assesed
2 secondary outcomes
Bone density
Time frame: 3 month
alveolar crest bone height
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 31346723Saulacic N, Munoz F, Kobayashi E, Chappuis V, Gonzales-Cantalapiedra A, Hofstetter W. Effects of local application of alendronate on early healing of extraction socket in dogs. Clin Oral Investig. 2020 Apr;24(4):1579-1589. doi: 10.1007/s00784-019-03031-7. Epub 2019 Jul 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohammed omara contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing socket preservation using sodium alendronate gel and socket preservation using sticky bone in people with Bone Quality Assessment and Preserved Sockets, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact aya elgohary (00201100122225, aya.elgohary@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histomorphometric analysis (time frame: 3 month from the socket preservation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05771038, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.