Socket PreservationNCT06983015
Sticky Bone vs Xenograft With Cross-linked Hyaluronic Acid in Socket Preservation
A study testing sticky bone and xenograft mixed with cross-linked hyaluronic acid in people with Socket Preservation, run by Fayoum University.
Trial summary
The present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Socket Preservation
- What is being tested?
- sticky bone and xenograft mixed with cross-linked hyaluronic acid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >18 years old.
- Patient with hopeless maxillary anteriors and premolar with cl ii socket that needs extraction and delayed implant placement.
Who cannot join
- Acute abscesses or active infections localized in the proximity of the surgical field.
- Presence of heavy metallic artefacts that can distort CBCT scans
- Bad oral hygiene and non-compliance.
- Systemic diseases interfering with bone healing.
- Active and progressive periodontal disease
- Smoking, alcoholism and drug abuse
- Pregnant and lactating women
About this study
Official title: The Effect of Sticky Bone vs Cross-linked Hyaluronic Acid With Xenograft in Socket Preservation: Randomized Controlled Trial
The present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation.
Read the detailed description
After teeth extraction, the alveolar process goes through a remodeling process that leads to dimensional changes that end up with a decrease in the width and height of the alveolar bone; these changes happening after tooth loss proves that the alveolar process bone is tooth dependent.
Alveolar bone remodeling is a physiological process observed after tooth extraction that may compromise the subsequent dental implant rehabilitation. Most of the alveolar bone loss occurs during the first 3-6 months after tooth extraction, resulting in a bone width loss of 29-63%, which leads to difficulties restoring the teeth either with conventional prosthesis or with implant supported prosthesis and in many cases implant placement becomes a challenge.
To compensate for this alveolar remodeling and create an aesthetically implantsupported prosthesis, many bone grafting techniques were proposed, including guided bone regeneration, onlay bone block, and alveolar ridge preservation.
The latter is a prophylactic technique that involves inserting various biomaterials into the socket to reduce post-extraction changes. The two most commonly used bone grafting materials are allografts and xenografts. The Alveolar ridge preservation seeks to achieve successful ridge reconstruction, which involves the production of new bone within the volume of the old socket. Although xenografts provide steady and adequate bone volume maintenance, their healing time and the percentage of de novo bone production remain their main downside.
To improve alveolar ridge preservation outcomes, researchers are attempting to reduce the healing period so that implants can be placed shortly after tooth extraction. As a result, numerous growth factors were investigated as biological adjuvants to aid in the healing process and prevent physiological post-extractive bone loss. Recent researches studied the use of cross-linked hyaluronic acid (xHyA) gel as a biological adjuvant to xenograft in order to increase regeneration capacity and decrease post-extraction resorption Hyaluronic acid an extracellular polymer of disaccharides administration appears to have a beneficial impact on the healing process and bone cell response by stimulating mesenchymal cells proliferation, growth factors attraction and angiogenesis in situ. the cross-linked hyaluronic acid had been introduced with a slow degradation profile to maintain a longer presence. The combination of crosslinked hyaluronic acid mixed with xenograft was proved to be better than the xenograft only regarding post-extraction socket bone regeneration "Sticky bone" is a composite biomaterial designed for bone regeneration, combining particulate bone substitutes with autologous platelet aggregates, such as PRF and concentrated growth factors. This adaptable material conforms to various bony defects, preventing graft movement and preserving bone volume during healing, thus minimizing the need for block bone and titanium mesh.
The sticky bone had been used in socket preservation and provides good bone quality for further implant placement. The placement of sticky bone resulted in grafted material adherence to the recipient sites without micro and macro movements, and the PRF matrix prevented early epithelial ingross onto the defect site, resulting in significant new bone gain in both horizontal and vertical dimensions Sareen et al. reported in their systematic review that a major limitation was the lack of randomized controlled trials that provide evidence on alveolar ridge preservation with sticky bone. They recommend larger studies to evaluate the interest of sticky bone in various surgical procedures by comparing it with other existing materials and conventional techniques.
The present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation.
- Conditions
- Socket Preservation
- Being tested
- sticky bone, xenograft mixed with cross-linked hyaluronic acid
- Keywords
- sticky bone, xenograft with cross-linked hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sticky boneProcedure or surgery
extraction socket will be augmented using a sticky bone.
xenograft mixed with cross-linked hyaluronic acidProcedure or surgery
Socket will be augmented with a mixture of xenograft and cross linked hyaluronic acid.
| Study group | Role | What they receive |
|---|---|---|
| sticky bone | Experimental | patients in this group will undergo tooth extraction and immediate augmentation using sticky bone Receives: Procedure: sticky bone |
| xenograft mixed with cross-linked hyaluronic acid | Active comparator | patients in this group will undergo tooth extraction and immediate augmentation using xenograft mixed with cross-linked hyaluronic acid Receives: Procedure: xenograft mixed with cross-linked hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points
A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points (8):
- Apico-coronally: Coronally the most crestal bone peak will be detected mesially and distally; apically, an artificial line was drawn 1.5 mm below the most apical point of the root tip across the apical base of the socket.
- Mesio-distally: limited by an artificial line at 1.5 mm distance of the most mesial and distal surface of adjacent tooth or implant.
- Bucco-lingually: limited to the mostly detectable bone width extension.
Measured: This measurement will be obtained at immediate postoperative and 6-months postoperative.
Secondary outcomes (3)
Bone density
Bone density: this will be measured immediately postoperative and at 6- monthpostoperative interval
Measured: This measurement will be obtained at immediate postoperative and 6-months postoperative.
Postoperative Pain
Postoperative Pain: will be assessed using pain score for assessment of quality of life measured on a 10-point visual analogue scale (VAS), the 0 indicating no pain and 10 indicating the worst pain ever at the following intervals: 1, 3, 7th day postoperative.
Measured: at the following intervals: 1, 3, 7th day postoperative.
Bone volume
Bone volume: alveolar ridge volumetric change, pre- and postoperative CBCT scans will be superimposed. In order to calculate the volumetric resorption rate (Percentage)
Measured: This measurement will be obtained at immediate postoperative and 6-months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study startJun 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective randomized (1:1) blinded clinical trial used an unstratified random block design (block sizes2, 4, and 6) to ensure balance in the number of patients assigned to each group. Informed consent for sharing clinical data and images for scientific purposes will be collected from all patients prior to commencement of the study, which was performed in accordance with the Declaration of Helsinki. The patients will be randomly assigned to one of the two groups according to the graft material: group I (Sticky bone) and group II (cross linked hyaluronic acid mixed with xenograft) where each patient will received either sticky bone or cross linked hyaluronic acid mixed with xenograft in the extraction socket according to the treatment group by the same operator. The graft material for extraction socket will be the primary predictor variable.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Salah Ali Mohamed, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983015
- Sponsor's protocol ID
- socket preservation
- Status last verified
- May 2025
- First submitted
- 13 May 2025
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sticky Bone vs Cross-linked Hyaluronic Acid With Xenograft in Socket Preservation: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06983015
- Acronym / sponsor ID
- socket preservation
- Conditions
- Socket Preservation
- Keywords
- sticky bone, xenograft with cross-linked hyaluronic acid
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 May 2025 (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 present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation.
Detailed description
After teeth extraction, the alveolar process goes through a remodeling process that leads to dimensional changes that end up with a decrease in the width and height of the alveolar bone; these changes happening after tooth loss proves that the alveolar process bone is tooth dependent.
Alveolar bone remodeling is a physiological process observed after tooth extraction that may compromise the subsequent dental implant rehabilitation. Most of the alveolar bone loss occurs during the first 3-6 months after tooth extraction, resulting in a bone width loss of 29-63%, which leads to difficulties restoring the teeth either with conventional prosthesis or with implant supported prosthesis and in many cases implant placement becomes a challenge.
To compensate for this alveolar remodeling and create an aesthetically implantsupported prosthesis, many bone grafting techniques were proposed, including guided bone regeneration, onlay bone block, and alveolar ridge preservation.
The latter is a prophylactic technique that involves inserting various biomaterials into the socket to reduce post-extraction changes. The two most commonly used bone grafting materials are allografts and xenografts. The Alveolar ridge preservation seeks to achieve successful ridge reconstruction, which involves the production of new bone within the volume of the old socket. Although xenografts provide steady and adequate bone volume maintenance, their healing time and the percentage of de novo bone production remain their main downside.
To improve alveolar ridge preservation outcomes, researchers are attempting to reduce the healing period so that implants can be placed shortly after tooth extraction. As a result, numerous growth factors were investigated as biological adjuvants to aid in the healing process and prevent physiological post-extractive bone loss. Recent researches studied the use of cross-linked hyaluronic acid (xHyA) gel as a biological adjuvant to xenograft in order to increase regeneration capacity and decrease post-extraction resorption Hyaluronic acid an extracellular polymer of disaccharides administration appears to have a beneficial impact on the healing process and bone cell response by stimulating mesenchymal cells proliferation, growth factors attraction and angiogenesis in situ. the cross-linked hyaluronic acid had been introduced with a slow degradation profile to maintain a longer presence. The combination of crosslinked hyaluronic acid mixed with xenograft was proved to be better than the xenograft only regarding post-extraction socket bone regeneration "Sticky bone" is a composite biomaterial designed for bone regeneration, combining particulate bone substitutes with autologous platelet aggregates, such as PRF and concentrated growth factors. This adaptable material conforms to various bony defects, preventing graft movement and preserving bone volume during healing, thus minimizing the need for block bone and titanium mesh.
The sticky bone had been used in socket preservation and provides good bone quality for further implant placement. The placement of sticky bone resulted in grafted material adherence to the recipient sites without micro and macro movements, and the PRF matrix prevented early epithelial ingross onto the defect site, resulting in significant new bone gain in both horizontal and vertical dimensions Sareen et al. reported in their systematic review that a major limitation was the lack of randomized controlled trials that provide evidence on alveolar ridge preservation with sticky bone. They recommend larger studies to evaluate the interest of sticky bone in various surgical procedures by comparing it with other existing materials and conventional techniques.
The present study aimed to evaluate clinical and radiographic outcomes of sticky bone in comparison to crosslinked hyaluronic acid mixed with xenograft in alveolar ridge preservation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective randomized (1:1) blinded clinical trial used an unstratified random block design (block sizes2, 4, and 6) to ensure balance in the number of patients assigned to each group. Informed consent for sharing clinical data and images for scientific purposes will be collected from all patients prior to commencement of the study, which was performed in accordance with the Declaration of Helsinki. The patients will be randomly assigned to one of the two groups according to the graft material: group I (Sticky bone) and group II (cross linked hyaluronic acid mixed with xenograft) where each patient will received either sticky bone or cross linked hyaluronic acid mixed with xenograft in the extraction socket according to the treatment group by the same operator. The graft material for extraction socket will be the primary predictor variable.
| Arm | Type | Receives |
|---|---|---|
| sticky bone | Experimental | Procedure: sticky bonepatients in this group will undergo tooth extraction and immediate augmentation using sticky bone |
| xenograft mixed with cross-linked hyaluronic acid | Active comparator | Procedure: xenograft mixed with cross-linked hyaluronic acidpatients in this group will undergo tooth extraction and immediate augmentation using xenograft mixed with cross-linked hyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >18 years old.
- Patient with hopeless maxillary anteriors and premolar with cl ii socket that needs extraction and delayed implant placement.
Key exclusion criteria (7 listed)
- Acute abscesses or active infections localized in the proximity of the surgical field.
- Presence of heavy metallic artefacts that can distort CBCT scans
- Bad oral hygiene and non-compliance.
- Systemic diseases interfering with bone healing.
- Active and progressive periodontal disease
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 |
|---|---|---|
| sticky boneextraction socket will be augmented using a sticky bone. | Procedure or surgery | sticky bone |
| xenograft mixed with cross-linked hyaluronic acidSocket will be augmented with a mixture of xenograft and cross linked hyaluronic acid. | Procedure or surgery | xenograft mixed with cross-linked hyaluronic acid |
Primary outcome
A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points
Time frame: This measurement will be obtained at immediate postoperative and 6-months postoperative.
A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points (8): * Apico-coronally: Coronally the most crestal bone peak will be detected mesially and distally; apically, an artificial line was drawn 1.5 mm below the most apical point of the root tip across the apical base of the socket. * Mesio-distally: limited by an artificial line at 1.5 mm distance of the most mesial and distal surface of adjacent tooth or implant. * Bucco-lingually: limited to the mostly detectable bone width extension.
3 secondary outcomes
Bone density
Time frame: This measurement will be obtained at immediate postoperative and 6-months postoperative.
Postoperative Pain
Time frame: at the following intervals: 1, 3, 7th day postoperative.
Bone volume
Time frame: This measurement will be obtained at immediate postoperative and 6-months postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Vallomix Socket Preservation Study
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing sticky bone and xenograft mixed with cross-linked hyaluronic acid in people with Socket Preservation, run by Fayoum University.
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A standardized region of interest (ROI) will be calibrated for all sites, determined by following reference points (time frame: This measurement will be obtained at immediate postoperative and 6-months postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 May 2025.