Bone ResorptionNCT06063980
Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone Height.
A study testing Conventional sinus lift surgery and Two-stage-sinus-lift procedure in people with Bone Resorption, run by VNU University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Resorption
- What is being tested?
- Conventional sinus lift surgery and Two-stage-sinus-lift procedure
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteVietnam
- Study dates
- 2 Mar 2019to 1 May 2023
- 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 40 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 0mm bone height at posterior maxillae region
Who cannot join
- general contraindication to implant surgery
- subjected to irradiation in the head and neck area <1 one year before implantation
- uncontrolled diabetes
- pregnant or nursing
- substance abuse
- heavy smoker
Show all 11Show fewer
- psychiatric therapy or unrealistic expectations
- immunosuppressed or immunocompromised
- treated or under treatment with oral or intravenous aminobisphosphonates
- untreated periodontitis
- poor oral hygiene and motivation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone
Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.
- Conditions
- Bone Resorption
- Being tested
- Conventional sinus lift surgery, Two-stage-sinus-lift procedure
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional sinus lift surgeryProcedure or surgery
After graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures.
Two-stage-sinus-lift procedureProcedure or surgery
Procedure is performed in two stages with the purpose of stage one to separate the oral mucosa from the sinus membrane using a small amount of bone graft and stage two as actual sinus augmentation, which is performed similar to that of conventional sinus lift procedure.
| Study group | Role | What they receive |
|---|---|---|
| Conventional sinus lift procedure | Other | Participants assigned to conventional sinus augmentation Receives: Procedure: Conventional sinus lift surgery |
| Two-stage-sinus-lift procedure | Other | Participants assigned to two-stage - sinus - lift procedure Receives: Procedure: Two-stage-sinus-lift procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone formation recorded after two-step-sinus-augmentation.
9,98mm bone height is recorded on CBCT.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start2 Mar 2019
- Primary completion25 Sep 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone ResorptionStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- VNU University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pham Nhu Hai, VNU University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063980
- Sponsor's protocol ID
- VNUMed
- Status last verified
- Oct 2023
- First submitted
- 19 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sinus Augmentation in the Posterior Maxillary Region: a Case Report of 0mm Bone
- ClinicalTrials.gov ID
- NCT06063980
- Acronym / sponsor ID
- VNUMed
- Conditions
- Bone Resorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- VNU University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 2 Mar 2019 (actual)
- Primary completion
- 25 Sep 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 3 Oct 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.
Sinus floor elevation (SFA) and GBR have been applied in the placement of dental implants in longstanding edentate posterior maxilla region. However, the number of study on the efficacy of these procedure on areas with 0mm bone height is limited. This case study aims to compare two cases of 0mm bone height in the posterior maxillae region with different handling procedure. In this article, two female patients in their 40s underwent maxillary sinus augmentation (sinus lifting) due to longstanding missing posterior maxillary molars with the bone of which area had resorbed entirely, leaving 0mm bone height. One patient went through conventional sinus augmentation while the other had a two-stage - sinus - lift procedure. Researchers compared the bone - volume induced between the two procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional sinus lift procedure | Other | Procedure: Conventional sinus lift surgeryParticipants assigned to conventional sinus augmentation |
| Two-stage-sinus-lift procedure | Other | Procedure: Two-stage-sinus-lift procedureParticipants assigned to two-stage - sinus - lift procedure |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 0mm bone height at posterior maxillae region
Key exclusion criteria (11 listed)
- general contraindication to implant surgery
- subjected to irradiation in the head and neck area <1 one year before implantation
- uncontrolled diabetes
- pregnant or nursing
- substance abuse
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 |
|---|---|---|
| Conventional sinus lift surgeryAfter graft reflection, sinus membrane is separated from bone or oral mucosa and then bone graft is inserted in between the two structures. | Procedure or surgery | Conventional sinus lift procedure |
| Two-stage-sinus-lift procedureProcedure is performed in two stages with the purpose of stage one to separate the oral mucosa from the sinus membrane using a small amount of bone graft and stage two as actual sinus augmentation, which is performed similar to that of conventional sinus lift procedure. | Procedure or surgery | Two-stage-sinus-lift procedure |
Primary outcome
Bone formation recorded after two-step-sinus-augmentation.
Time frame: 21 months
9,98mm bone height is recorded on CBCT.
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 3 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Bone Resorption
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
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 Conventional sinus lift surgery and Two-stage-sinus-lift procedure in people with Bone Resorption, run by VNU 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 1 inclusion and 11 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 3 Oct 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 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?
Bone formation recorded after two-step-sinus-augmentation. (time frame: 21 months). 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 3 Oct 2023.