Implant Site ReactionNCT07186166
Sinus Augmentation With Allograft-Bone Substitute in Severe Maxillary Atrophy
A study testing 30% HA+70% β-TCP (Osteon II, Dentium, Korea) in people with Implant Site Reaction, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
This study was conducted in two phases. In Phase 1, lateral window sinus floor augmentation was performed using a mixture of hydroxyapatite (30%) and β-tricalcium phosphate (70%) combined with autologous platelet-rich fibrin (PRF). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Implant Site Reaction
- What is being tested?
- 30% HA+70% β-TCP (Osteon II, Dentium, Korea)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jan 2022to 1 Feb 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with a residual bone height ≤4 mm
- minimum prosthetic space of 5 mm
Who cannot join
- Patients with acute or chronic maxillary sinusitis, bleeding disorders, diabetes mellitus, bone metabolic diseases, periodontal disease, or malignancies were excluded.
- taking medications that could affect bone metabolism or hemostasis
- Smokers and pregnant women were also excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lateral Window Sinus Augmentation in Severe Maxillary Atrophy: A Histological and Histomorphometric Study Using Allograft and Bone Substitute
This study was conducted in two phases. In Phase 1, lateral window sinus floor augmentation was performed using a mixture of hydroxyapatite (30%) and β-tricalcium phosphate (70%) combined with autologous platelet-rich fibrin (PRF). Standard surgical protocols were followed, including prophylactic antibiotics, local anesthesia, and careful elevation of the Schneiderian membrane prior to graft placement.
In Phase 2, after six months of healing, core bone biopsies were harvested with a trephine drill at the planned implant site for histological analysis. Specimens were processed using standardized laboratory protocols and evaluated with light microscopy and digital imaging. Quantitative histomorphometric analysis was performed using ImageJ software to determine the area fractions of newly formed bone and residual graft material. Following biopsy retrieval, dental implants were placed and primary stability was measured with the Implant Stability Quotient (ISQ).
Read the detailed description
Phase 1: Lateral window sinus floor augmentation, bone graft The patient was prescribed a prophylactic antibiotic regimen consisting of Amoxicillin with Clavulanic Acid (1 g Augmentin tablet), taken one hour before the procedure. Local anesthesia was administered using 2% Lidocaine with Epinephrine (1:100,000). A crestal incision was made along the maxillary alveolar ridge, and a full-thickness mucoperiosteal flap was elevated to expose the surgical site. A lateral window was then prepared in the lateral maxillary wall using a piezotome. The Schneiderian membrane was carefully elevated using the sinus lift augmentation technique. For the grafting procedure, the material was prepared by mixing 30% HA with 70% β-TCP (Osteon II, Dentium, Korea), in a 1:1 ratio, combined with autologous Platelet-Rich Fibrin (PRF) obtained from the patient's blood.
Phase 2: The histological analysis of the bone grafts and implant placement After a healing period of six months, a second-stage surgery was carried out to remove bone tissue and place the implant. At the designated implant site, a trephine drill with a 3 mm outer diameter was used to obtain a core bone biopsy specimen for histological analysis. The biopsy samples were encoded, fixed in 10% formalin, and submitted to the Embryology Department at the University of Medicine and Pharmacy at Ho Chi Minh City, where a standardized protocol was followed for specimen preparation. Histological evaluation was performed using an Olympus BX51 optical microscope connected to an Olympus DP72 12.5 MP digital camera, with captured images transmitted to a computer for assessment of histological parameters. Following biopsy retrieval, the implant osteotomy was completed, and the implant was inserted. Primary stability was assessed using the Implant Stability Quotient (ISQ) index.
Histological sections were analyzed using ImageJ software to quantify the area fractions of newly formed bone and residual graft particles, following established protocols. For each biopsy, three stained sections were evaluated, and the mean value was calculated. The regions corresponding to newly formed bone and residual graft material were delineated using the polygon selection tool, and the software computed their surface areas. The area fraction percentage (AA%) was then expressed as a proportion of the total image surface.
- Conditions
- Implant Site Reaction
- Being tested
- 30% HA+70% β-TCP (Osteon II, Dentium, Korea)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
30% HA+70% β-TCP (Osteon II, Dentium, Korea)Combination product
A prospective analysis was performed on a single-arm clinical trial involving 60 posterior maxillary edentulous sites in 42 patients with a residual bone height of <4 mm. All sites were treated with lateral window sinus floor augmentation (LWSFA), followed by grafting using a 1:1 ratio of 30% HA with 70% β-TCP (Osteon II, Dentium, Korea). At 6 months postoperatively, core biopsies were harvested during implant placement to assess the histological outcomes of the grafted sites.
| Study group | Role | What they receive |
|---|---|---|
| Lateral Window Sinus Floor Augmentation with 30% HA + 70% β-TCP Graft | Experimental | A prospective single-arm clinical trial was conducted on 60 posterior maxillary edentulous sites in 42 patients with residual bone height < 4 mm. All sites underwent LWSFA, followed by grafting with a 1:1 ratio of 30% HA and 70% β-TCP. At 6 months post-operation, core biopsies were collected during implant placement for histologic evaluation of the grafted sites. Receives: Combination Product: 30% HA+70% β-TCP (Osteon II, Dentium, Korea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological outcomes
Histomorphometric evaluation of core biopsies obtained 6 months after maxillary sinus augmentation to quantify the percentage of newly formed bone, residual graft material, and connective tissue. Data will be summarized as mean ± SD and compared between groups.
Measured: Baseline (T0), After 6 months (T6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start1 Jan 2022
- Primary completion1 Feb 2024
- Study completion1 Feb 2024
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 Implant Site ReactionStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Can Tho University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07186166
- Sponsor's protocol ID
- CTUMP
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2025
- Last updated
- 22 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nguyen GH, Le KVP, Le LN, Vo NV. Histological and histomorphometric assessment of lateral window sinus augmentation in severe maxillary atrophy using a mixed allograft with beta-TCP/HA and autologous platelet-rich fibrin. BMC Oral Health. 2026 Apr 28;26(1):1252. doi: 10.1186/s12903-026-08332-4.
PubMed 42050510
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Window Sinus Augmentation in Severe Maxillary Atrophy: A Histological and Histomorphometric Study Using Allograft and Bone Substitute
- ClinicalTrials.gov ID
- NCT07186166
- Acronym / sponsor ID
- CTUMP
- Conditions
- Implant Site Reaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Can Tho University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 22 Sep 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.
This study was conducted in two phases. In Phase 1, lateral window sinus floor augmentation was performed using a mixture of hydroxyapatite (30%) and β-tricalcium phosphate (70%) combined with autologous platelet-rich fibrin (PRF). Standard surgical protocols were followed, including prophylactic antibiotics, local anesthesia, and careful elevation of the Schneiderian membrane prior to graft placement.
In Phase 2, after six months of healing, core bone biopsies were harvested with a trephine drill at the planned implant site for histological analysis. Specimens were processed using standardized laboratory protocols and evaluated with light microscopy and digital imaging. Quantitative histomorphometric analysis was performed using ImageJ software to determine the area fractions of newly formed bone and residual graft material. Following biopsy retrieval, dental implants were placed and primary stability was measured with the Implant Stability Quotient (ISQ).
Detailed description
Phase 1: Lateral window sinus floor augmentation, bone graft The patient was prescribed a prophylactic antibiotic regimen consisting of Amoxicillin with Clavulanic Acid (1 g Augmentin tablet), taken one hour before the procedure. Local anesthesia was administered using 2% Lidocaine with Epinephrine (1:100,000). A crestal incision was made along the maxillary alveolar ridge, and a full-thickness mucoperiosteal flap was elevated to expose the surgical site. A lateral window was then prepared in the lateral maxillary wall using a piezotome. The Schneiderian membrane was carefully elevated using the sinus lift augmentation technique. For the grafting procedure, the material was prepared by mixing 30% HA with 70% β-TCP (Osteon II, Dentium, Korea), in a 1:1 ratio, combined with autologous Platelet-Rich Fibrin (PRF) obtained from the patient's blood.
Phase 2: The histological analysis of the bone grafts and implant placement After a healing period of six months, a second-stage surgery was carried out to remove bone tissue and place the implant. At the designated implant site, a trephine drill with a 3 mm outer diameter was used to obtain a core bone biopsy specimen for histological analysis. The biopsy samples were encoded, fixed in 10% formalin, and submitted to the Embryology Department at the University of Medicine and Pharmacy at Ho Chi Minh City, where a standardized protocol was followed for specimen preparation. Histological evaluation was performed using an Olympus BX51 optical microscope connected to an Olympus DP72 12.5 MP digital camera, with captured images transmitted to a computer for assessment of histological parameters. Following biopsy retrieval, the implant osteotomy was completed, and the implant was inserted. Primary stability was assessed using the Implant Stability Quotient (ISQ) index.
Histological sections were analyzed using ImageJ software to quantify the area fractions of newly formed bone and residual graft particles, following established protocols. For each biopsy, three stained sections were evaluated, and the mean value was calculated. The regions corresponding to newly formed bone and residual graft material were delineated using the polygon selection tool, and the software computed their surface areas. The area fraction percentage (AA%) was then expressed as a proportion of the total image surface.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lateral Window Sinus Floor Augmentation with 30% HA + 70% β-TCP Graft | Experimental | Combination Product: 30% HA+70% β-TCP (Osteon II, Dentium, Korea)A prospective single-arm clinical trial was conducted on 60 posterior maxillary edentulous sites in 42 patients with residual bone height < 4 mm. All sites underwent LWSFA, followed by grafting with a 1:1 ratio of 30% HA and 70% β-TCP. At 6 months post-operation, core biopsies were collected during implant placement for histologic evaluation of the grafted sites. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with a residual bone height ≤4 mm
- minimum prosthetic space of 5 mm
Key exclusion criteria (3 listed)
- Patients with acute or chronic maxillary sinusitis, bleeding disorders, diabetes mellitus, bone metabolic diseases, periodontal disease, or malignancies were excluded.
- taking medications that could affect bone metabolism or hemostasis
- Smokers and pregnant women were also excluded from 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 |
|---|---|---|
| 30% HA+70% β-TCP (Osteon II, Dentium, Korea)A prospective analysis was performed on a single-arm clinical trial involving 60 posterior maxillary edentulous sites in 42 patients with a residual bone height of <4 mm. All sites were treated with lateral window sinus floor augmentation (LWSFA), followed by grafting using a 1:1 ratio of 30% HA with 70% β-TCP (Osteon II, Dentium, Korea). At 6 months postoperatively, core biopsies were harvested during implant placement to assess the histological outcomes of the grafted sites. | Combination product | Lateral Window Sinus Floor Augmentation with 30% HA + 70% β-TCP Graft |
Primary outcome
Histological outcomes
Time frame: Baseline (T0), After 6 months (T6)
Histomorphometric evaluation of core biopsies obtained 6 months after maxillary sinus augmentation to quantify the percentage of newly formed bone, residual graft material, and connective tissue. Data will be summarized as mean ± SD and compared between groups.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Derived from this study: PubMed 42050510Nguyen GH, Le KVP, Le LN, Vo NV. Histological and histomorphometric assessment of lateral window sinus augmentation in severe maxillary atrophy using a mixed allograft with beta-TCP/HA and autologous platelet-rich fibrin. BMC Oral Health. 2026 Apr 28;26(1):1252. doi: 10.1186/s12903-026-08332-4.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 30% HA+70% β-TCP (Osteon II, Dentium, Korea) in people with Implant Site Reaction, run by Can Tho University of Medicine and Pharmacy at 1 site in Vietnam.
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 3 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: finished, as of the sponsor's last update on 22 Sep 2025. 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 Vietnam. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Histological outcomes (time frame: Baseline (T0), After 6 months (T6)). 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 NCT07186166, 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 22 Sep 2025.