Atrophic MaxillaNCT07014085
Prospective Study of Bone Augmentation With Lateral Sinus Lift and Osseointegration of Dental Implants
A study testing "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study in people with Atrophic Maxilla and Partial Edentulism, run by Maria H. Pham.
Trial summary
By using a split-mouth model in the maxilla, lateral sinus lift procedures will be performed using xenograft on one side vs autologous bone augmentation and PRF membranes on the other side. The purpose is to qualify and verify each step of this study to ensure the reliability and validity of the results. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophic Maxilla, Partial Edentulism
- What is being tested?
- "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 31 Dec 2035
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Partially edentulous jaws in the lateral segment with 2 or more nearby lost teeth in the posterior upper jaw (maxilla), where the vertical height is a minimum of 2mm
- absence of marginal periodontal disease
- patients in American Society of Anesthesiologists ASA group 1-2 over 18 years.
Who cannot join
- ASA group 3 and above
- ongoing infection
- bruxism or abnormal habit
- poor oral hygiene
- medical conditions that may compromise healing (uncontrolled diabetes etc)
- treatments that interfere with healing in the jaw bone (bisphosphonate, steroid therapy) radiotherapy or chemotherapy within the last 5 years
Show all 10Show fewer
- alcohol or substance abuse
- heavy smoking
- pregnancy
- desire not to participate
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Histomorphometric Evaluation of Bone Augmentation Using Xenograft vs Autologous Bone Graft With Dental Implants. A Comparative Clinical Study.
By using a split-mouth model in the maxilla, lateral sinus lift procedures will be performed using xenograft on one side vs autologous bone augmentation and PRF membranes on the other side. The purpose is to qualify and verify each step of this study to ensure the reliability and validity of the results.
Read the detailed description
Title: "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study"
Objective: This study aims to compare and analyse the effectiveness of xenograft and autologous bone grafts in bone augmentation procedures for patients requiring dental implants in a clinical setting. By comparing the outcomes of bone augmentation using xenografts and autologous bone grafts, this study aims to develop treatment protocols prioritising reduced invasiveness and enhanced efficiency. Understanding which grafting material yields better osseointegration can lead to more streamlined procedures, benefiting clinicians and patients. Furthermore, we aim to assess their efficacy in achieving optimal outcomes in bone augmentation procedures by implants and biomaterials in the study. The unique aspect of this study is the use of a split-mouth model and advanced digital technologies for data collection and analysis, which can provide more accurate and comprehensive insights into the comparative effectiveness of xenografts and autologous bone grafts.
Methodology: Utilizing a split-mouth model in the maxilla, external lateral sinus lift procedures will be performed using xenograft on one side and autologous bone augmentation and PRF membranes on the other side of the patients. A total of 20 patients will be included, with 40 implants placed. As part of the study methodology, digital technologies will be utilised for data collection and analysis. This includes digital imaging techniques for pre-operative assessment and post-operative evaluation of bone augmentation outcomes. By leveraging digital technologies, we aim to enhance the accuracy and efficiency of data collection, enabling comprehensive analysis of the comparative effectiveness of xenografts and autologous bone grafts. Rest assured, every step of this study has been meticulously planned and executed to ensure the reliability and validity of the results.
Rationale: The success of dental implants, particularly in cases of partial or total edentulism with jaw atrophy, hinges on achieving primary stability and osseointegration. Bone augmentation using either xenograft or autologous bone has been commonly employed for such treatments. However, there is an urgent need for further clinical research to evaluate the osseointegration outcomes between xenografts and autologous bone in bone augmentation procedures. The comparative analysis of xenografts and autologous bone grafts will provide crucial insights into the prevention and management of complications such as infection, graft failure, and resorption associated with bone augmentation procedures. By identifying which grafting material leads to fewer biological and technical complications, clinicians can tailor treatment protocols to minimize adverse events and maximize patient safety. This aligns with Straumann's commitment to continuously improving treatment protocols to ensure the long-term success of dental implants and restorative procedures.
Significance: With the ageing population and increasing prevalence of partial or total edentulism, the challenges associated with dental implants will continue to rise. Bone augmentation using xenografts or autologous grafts can potentially enhance implant stability and success rates, improving patients' quality of life and mental well-being. This study aims to contribute valuable insights into treatment protocols that can positively impact patient outcomes.
- Conditions
- Atrophic Maxilla, Partial Edentulism
- Being tested
- "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study
- Keywords
- bone augmentation, dento alveolar surgery, oral surgery, comparative prospective study, clinical study, lateral sinus lift, dental implants, osseointegration, prf, autologus graft, xenograft, atrophic maxilla
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical StudyProcedure or surgery
Split mouth comparative clinical prospective study xenograft vs autologous graft
| Study group | Role | What they receive |
|---|---|---|
| 5 years follow up study | Other | osseointegration 5 year follow up Receives: Procedure: "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of autogenous bone graft vs xenograft
Quality measurements of bone augmentation with autologous and xenograft with histology and radiological examination
Measured: Up to two years
Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts Dental Implant Patients: A Comparative Clinical Study
Measurement of survival rates and osseointegration of dental implants with questionnaires and radiology examination
Measured: Up til 2 years
Secondary outcomes (1)
A prospective clinical study 3 years of follow up: Bone graft with dental implants
Survival rate and measurements with dental implants with questionnaires and radiology examination
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic MaxillaStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- split mouth, using the participant as a control vs test group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria H. Pham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maria H. Pham, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014085
- Sponsor's protocol ID
- Oral surgery and Oral medicine
- Status last verified
- Jun 2025
- First submitted
- 12 May 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histomorphometric Evaluation of Bone Augmentation Using Xenograft vs Autologous Bone Graft With Dental Implants. A Comparative Clinical Study.
- ClinicalTrials.gov ID
- NCT07014085
- Acronym / sponsor ID
- Oral surgery and Oral medicine
- Conditions
- Atrophic Maxilla, Partial Edentulism
- Keywords
- bone augmentation, dento alveolar surgery, oral surgery, comparative prospective study, clinical study, lateral sinus lift, dental implants, osseointegration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maria H. PhamUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 10 Jun 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.
By using a split-mouth model in the maxilla, lateral sinus lift procedures will be performed using xenograft on one side vs autologous bone augmentation and PRF membranes on the other side. The purpose is to qualify and verify each step of this study to ensure the reliability and validity of the results.
Detailed description
Title: "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study"
Objective: This study aims to compare and analyse the effectiveness of xenograft and autologous bone grafts in bone augmentation procedures for patients requiring dental implants in a clinical setting. By comparing the outcomes of bone augmentation using xenografts and autologous bone grafts, this study aims to develop treatment protocols prioritising reduced invasiveness and enhanced efficiency. Understanding which grafting material yields better osseointegration can lead to more streamlined procedures, benefiting clinicians and patients. Furthermore, we aim to assess their efficacy in achieving optimal outcomes in bone augmentation procedures by implants and biomaterials in the study. The unique aspect of this study is the use of a split-mouth model and advanced digital technologies for data collection and analysis, which can provide more accurate and comprehensive insights into the comparative effectiveness of xenografts and autologous bone grafts.
Methodology: Utilizing a split-mouth model in the maxilla, external lateral sinus lift procedures will be performed using xenograft on one side and autologous bone augmentation and PRF membranes on the other side of the patients. A total of 20 patients will be included, with 40 implants placed. As part of the study methodology, digital technologies will be utilised for data collection and analysis. This includes digital imaging techniques for pre-operative assessment and post-operative evaluation of bone augmentation outcomes. By leveraging digital technologies, we aim to enhance the accuracy and efficiency of data collection, enabling comprehensive analysis of the comparative effectiveness of xenografts and autologous bone grafts. Rest assured, every step of this study has been meticulously planned and executed to ensure the reliability and validity of the results.
Rationale: The success of dental implants, particularly in cases of partial or total edentulism with jaw atrophy, hinges on achieving primary stability and osseointegration. Bone augmentation using either xenograft or autologous bone has been commonly employed for such treatments. However, there is an urgent need for further clinical research to evaluate the osseointegration outcomes between xenografts and autologous bone in bone augmentation procedures. The comparative analysis of xenografts and autologous bone grafts will provide crucial insights into the prevention and management of complications such as infection, graft failure, and resorption associated with bone augmentation procedures. By identifying which grafting material leads to fewer biological and technical complications, clinicians can tailor treatment protocols to minimize adverse events and maximize patient safety. This aligns with Straumann's commitment to continuously improving treatment protocols to ensure the long-term success of dental implants and restorative procedures.
Significance: With the ageing population and increasing prevalence of partial or total edentulism, the challenges associated with dental implants will continue to rise. Bone augmentation using xenografts or autologous grafts can potentially enhance implant stability and success rates, improving patients' quality of life and mental well-being. This study aims to contribute valuable insights into treatment protocols that can positively impact patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- split mouth, using the participant as a control vs test group
| Arm | Type | Receives |
|---|---|---|
| 5 years follow up study | Other | Procedure: "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Studyosseointegration 5 year follow up |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Partially edentulous jaws in the lateral segment with 2 or more nearby lost teeth in the posterior upper jaw (maxilla), where the vertical height is a minimum of 2mm
- absence of marginal periodontal disease
- patients in American Society of Anesthesiologists ASA group 1-2 over 18 years.
Key exclusion criteria (10 listed)
- ASA group 3 and above
- ongoing infection
- bruxism or abnormal habit
- poor oral hygiene
- medical conditions that may compromise healing (uncontrolled diabetes etc)
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 |
|---|---|---|
| "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical StudySplit mouth comparative clinical prospective study xenograft vs autologous graft | Procedure or surgery | 5 years follow up study |
Primary outcome
Effect of autogenous bone graft vs xenograft
Time frame: Up to two years
Quality measurements of bone augmentation with autologous and xenograft with histology and radiological examination
Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts Dental Implant Patients: A Comparative Clinical Study
Time frame: Up til 2 years
Measurement of survival rates and osseointegration of dental implants with questionnaires and radiology examination
1 secondary outcome
A prospective clinical study 3 years of follow up: Bone graft with dental implants
Time frame: Up to 3 years
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 24 Jun 2025.
- Individual participant dataSharing planned: Yes
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Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
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Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
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Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
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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.
Questions about this trial
What is this clinical trial studying?
A study testing "Histomorphometric Evaluation of Bone Augmentation Using Xenografts Versus Autologous Bone Grafts in Dental Implant Patients: A Comparative Clinical Study in people with Atrophic Maxilla and Partial Edentulism, run by Maria H. Pham.
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 3 inclusion and 10 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 24 Jun 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?
Contact Maria H Pham, DDS, PhD (+4740044139, hmnpham@uio.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of autogenous bone graft vs xenograft (time frame: Up to two years). The study lists 2 primary outcomes in all. 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 24 Jun 2025.