Tooth FracturesNCT05505084
Alveolar Ridge Preservation Following Tooth Extraction.
An observational study of Tooth Fractures and Tooth Extraction Status Nos, run by University of Pennsylvania at 1 site in United States.
Trial summary
Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Fractures, Tooth Extraction Status Nos, Caries
- What is being tested?
- Tooth extraction and ridge preservation using different barrier mermbranes
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2022to 31 Dec 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of subjects presenting to the University of Pennsylvania School of Dental Medicine who require extraction of a hopeless tooth due to trauma, caries, or endodontic/periodontal reasons, and who are interested in replacing their tooth with a dental implant.
Who may be able to join
- Subjects must between the ages of 18 and 80.
- Subjects must require removal of at least one maxillary premolar
- Subjects should benefit from an implant-supported crown.
- Subjects must have voluntarily signed the informed consent form.
- Subjects must be assessed as ASA I, ASA II by a member of the research team.
Who cannot join
- Medical conditions requiring the use of steroids.
- History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis.
- History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck.
- Subjects who have diabetes mellitus.
- Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment in the study.
- Alcohol or drug abuse.
- Subjects who are heavy smokers (greater than 10 cigarettes per day or cigar equivalents) or chew tobacco.
- Conditions or circumstances, in the opinion of the research team, which would prevent completion of study participation or interfere with analysis of study results, such as a history of non-compliance or unreliability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Dental Medicine
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study
Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method.
In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge?
The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.
Read the detailed description
The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months.
The following products will be used during the study:
- Collatape (Zimmer Dental)- approved by the FDA (class III)
- Cytoplast (Osteogenics Biomedical)- cleared by the FDA
- OssixPlus (Dantum Dental)- cleared by the FDA
- Renovix-Plus (Salvin)- cleared by the FDA
- BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking
- PuroⓇ, Zimmer Dental)- cleared by the FDA
- RegenerOssⓇ, Zimmer Dental) - cleared by the FDA
During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following:
- % viable of bone
- % of connective tissue
- % of residual graft material
- Conditions
- Tooth Fractures, Tooth Extraction Status Nos, Caries
- Being tested
- Tooth extraction and ridge preservation using different barrier mermbranes
- Keywords
- implant, alveolar ridge preservation
- Medical subject headings
- Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction and ridge preservation using different barrier mermbranesProcedure or surgery
The hopeless and unrestorable teeth are planned for extraction and implant placement.
| Study group | Role | What they receive |
|---|---|---|
| Collatape (Zimmer Dental) | This material is a resorbable collagen wound dressing. They are made from bovine Achilles tendons and are a source of Type I collagen. The resorbable wound dressings are sterilized after purification with ethylene oxide. Receives: Procedure: Tooth extraction and ridge preservation using different barrier mermbranes | |
| Cytoplast Barrier Membranes TXT-200 Singles (Osteogenics Biomedical) | Cytoplast Barrier membranes are manufactured from high-density Polytetrafluoroethylene (PTFE) which allows them to withstand exposure to the oral environment. The textured surface increases the surface area available for cellular attachment during dental bone grafting procedures thereby aiding in stabilizing the PTFE membrane. It can be removed non-surgically after at least 21 days. Receives: Procedure: Tooth extraction and ridge preservation using different barrier mermbranes | |
| Ossix Plus (dantum dental) | OssixPlus is a resorbable collagen dental membrane used for Guided Bone Regeneration and Guided Tissue Regeneration. It contains a patented GLYMATRIX cross-linking technology that allows it to maintain barrier functionality for 4 to 6 months. The collagen is derived from porcine. Receives: Procedure: Tooth extraction and ridge preservation using different barrier mermbranes | |
| Renovix-Plus (Salvin) | Renovix Plus is a non-cross-linked extracellular matrix containing Type I, II, and III Collagen, Fibronectin, Laminin, and Elastin. It provides architecture and barrier protection for bone regeneration and soft tissue esthetics. This membrane resorbs within six months. Receives: Procedure: Tooth extraction and ridge preservation using different barrier mermbranes | |
| BioXclude (Snoasis) | BioXclude is a minimally manipulated allograft amnion chorion tissue. It is obtained from consenting mothers who donate their placentas after elective caesarian section delivery. The tissue is processed to cleanse and maintain the tissue. Following processing and dehydration, the allografts are packaged and terminally sterilized. Receives: Procedure: Tooth extraction and ridge preservation using different barrier mermbranes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ridge dimension changes before and after the augmentation.
The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction.
Measured: from the date of the extraction 4 months
Histological Evaluation
A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen.
Measured: 4 months post-augmentation
Secondary outcomes (2)
Implant site conditions
- Implant stability quotients as determined by resonance frequency analysis.
Measured: 4 months post-augmentation
Implant site conditions
change of the periodontal phenotype
Measured: 4 months post-augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start15 Aug 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Tooth FracturesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- ZimVie
- Responsible party
- Principal investigator, Yucheng Chang, University of Pennsylvania
- Investigators
- Yu-Cheng Chang, DMD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505084
- Sponsor's protocol ID
- 828879
- Status last verified
- Apr 2026
- First submitted
- 1 Jun 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
PubMed 9203100Ismail NM, Mustapha MS, Megat R. The subcellular localisation and the time course of bismuth in the gastric mucosa of rats after short-term administration of colloidal bismuth subcitrate. Ann Acad Med Singap. 1997 Nov;26(6):754-7.
PubMed 9522974Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
PubMed 22211303Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
PubMed 19929956Misawa M, Lindhe J, Araujo MG. The alveolar process following single-tooth extraction: a study of maxillary incisor and premolar sites in man. Clin Oral Implants Res. 2016 Jul;27(7):884-9. doi: 10.1111/clr.12710. Epub 2015 Nov 14.
PubMed 26566965Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
PubMed 24966231Corbella S, Taschieri S, Francetti L, Weinstein R, Del Fabbro M. Histomorphometric Results After Postextraction Socket Healing with Different Biomaterials: A Systematic Review of the Literature and Meta-Analysis. Int J Oral Maxillofac Implants. 2017 September/October;32(5):1001-1017. doi: 10.11607/jomi.5263. Epub 2017 Feb 23.
PubMed 28231347Jung RE, Ioannidis A, Hammerle CHF, Thoma DS. Alveolar ridge preservation in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):165-175. doi: 10.1111/prd.12209. Epub 2018 Feb 27.
PubMed 29484712Bassir SH, Alhareky M, Wangsrimongkol B, Jia Y, Karimbux N. Systematic Review and Meta-Analysis of Hard Tissue Outcomes of Alveolar Ridge Preservation. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):979-994. doi: 10.11607/jomi.6399.
PubMed 30231083Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
PubMed 32050833
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Five Distinct Membranes for Preservation of the Alveolar Ridge Following Tooth Extraction: A Prospective, Randomized, Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05505084
- Acronym / sponsor ID
- 828879
- Conditions
- Tooth Fractures, Tooth Extraction Status Nos, Caries
- Keywords
- implant, alveolar ridge preservation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- ZimVie
- Study start
- 15 Aug 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 17 Aug 2022 (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.
Bone resorption after a tooth extraction is a generally accepted knowledge and has been demonstrated by many animal and human studies. Especially during the first three months followed by the tooth extraction, the volume of bone may change significantly without any interference. Thus, doing a ridge preservation procedure following the extraction is a common standard of care method to maintain the socket volume if implant placement is considered as a treatment option in the future. A variety of materials and methods have been used for ridge preservation. However, it's still inconclusive to determine the best material to maintain the ridge dimension, especially for membrane placement that allows for space maintenance to protect the grafting material. Furthermore, there is no evidence to show any treatment rationale is superior to any other ridge preservation method.
In general, the membrane serves the function of the barrier and space protector. The periodontal surgeon use membranes to exclude the epithelium growth and to limit the collapse of the soft tissue into the healing alveolar socket. Regarding resorbable and non-resorbable membrane materials, both serve the function of protecting the graft material from the oral cavity. However, there are also many demonstrating that without membranes the extraction socket healed nicely without any interferences. The question to us is: Do we need the membrane to exclude the epithelium or any kind of surgical dressing material is sufficient enough to preserve the volume of the extracted ridge?
The object of this study is to compare five popular membranes on the market that present different characteristics of the membranes.
Detailed description
The extraction and the grafting procedure involved in this study are standard of care. The investigators will extract the hopeless teeth and prepare the site for implant placement in 4 months.
The following products will be used during the study:
- Collatape (Zimmer Dental)- approved by the FDA (class III)
- Cytoplast (Osteogenics Biomedical)- cleared by the FDA
- OssixPlus (Dantum Dental)- cleared by the FDA
- Renovix-Plus (Salvin)- cleared by the FDA
- BioXclude (SNOASIS)-certificate from the American Association of Tissue Banking
- PuroⓇ, Zimmer Dental)- cleared by the FDA
- RegenerOssⓇ, Zimmer Dental) - cleared by the FDA
During the appointment for the implant placement. A bone core from all subjects in each treatment group will be collected from the augmentation site instead of drilling away. The sample will be evaluated for the following:
- % viable of bone
- % of connective tissue
- % of residual graft material
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Collatape (Zimmer Dental) | – | Procedure: Tooth extraction and ridge preservation using different barrier mermbranesThis material is a resorbable collagen wound dressing. They are made from bovine Achilles tendons and are a source of Type I collagen. The resorbable wound dressings are sterilized after purification with ethylene oxide. |
| Cytoplast Barrier Membranes TXT-200 Singles (Osteogenics Biomedical) | – | Procedure: Tooth extraction and ridge preservation using different barrier mermbranesCytoplast Barrier membranes are manufactured from high-density Polytetrafluoroethylene (PTFE) which allows them to withstand exposure to the oral environment. The textured surface increases the surface area available for cellular attachment during dental bone grafting procedures thereby aiding in stabilizing the PTFE membrane. It can be removed non-surgically after at least 21 days. |
| Ossix Plus (dantum dental) | – | Procedure: Tooth extraction and ridge preservation using different barrier mermbranesOssixPlus is a resorbable collagen dental membrane used for Guided Bone Regeneration and Guided Tissue Regeneration. It contains a patented GLYMATRIX cross-linking technology that allows it to maintain barrier functionality for 4 to 6 months. The collagen is derived from porcine. |
| Renovix-Plus (Salvin) | – | Procedure: Tooth extraction and ridge preservation using different barrier mermbranesRenovix Plus is a non-cross-linked extracellular matrix containing Type I, II, and III Collagen, Fibronectin, Laminin, and Elastin. It provides architecture and barrier protection for bone regeneration and soft tissue esthetics. This membrane resorbs within six months. |
| BioXclude (Snoasis) | – | Procedure: Tooth extraction and ridge preservation using different barrier mermbranesBioXclude is a minimally manipulated allograft amnion chorion tissue. It is obtained from consenting mothers who donate their placentas after elective caesarian section delivery. The tissue is processed to cleanse and maintain the tissue. Following processing and dehydration, the allografts are packaged and terminally sterilized. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of subjects presenting to the University of Pennsylvania School of Dental Medicine who require extraction of a hopeless tooth due to trauma, caries, or endodontic/periodontal reasons, and who are interested in replacing their tooth with a dental implant.
Key inclusion criteria (5 listed)
- Subjects must between the ages of 18 and 80.
- Subjects must require removal of at least one maxillary premolar
- Subjects should benefit from an implant-supported crown.
- Subjects must have voluntarily signed the informed consent form.
- Subjects must be assessed as ASA I, ASA II by a member of the research team.
Key exclusion criteria (8 listed)
- Medical conditions requiring the use of steroids.
- History of leukocyte dysfunction or deficiencies, bleeding deficiencies, renal failure, uncontrolled endocrine disorders, acquired immunodeficiency syndrome or hepatitis.
- History of neoplastic disease requiring the use of chemotherapy or irradiation to head and neck.
- Subjects who have diabetes mellitus.
- Subjects who have undergone administration of any investigational drug or device within 30 days of enrollment 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 |
|---|---|---|
| Tooth extraction and ridge preservation using different barrier mermbranesThe hopeless and unrestorable teeth are planned for extraction and implant placement. | Procedure or surgery | BioXclude (Snoasis), Collatape (Zimmer Dental), Cytoplast Barrier Membranes TXT-200 Singles (Osteogenics Biomedical), Ossix Plus (dantum dental), Renovix-Plus (Salvin) |
Primary outcome
Ridge dimension changes before and after the augmentation.
Time frame: from the date of the extraction 4 months
The change in alveolar ridge dimensions will be assessed using CBCT technology after extraction and 4 months after extraction.
Histological Evaluation
Time frame: 4 months post-augmentation
A bone core from all subjects in each treatment group will be taken from the augmentation site at the time of implant placement (4 months post-augmentation) and will be evaluated for the composition of the specimen.
2 secondary outcomes
Implant site conditions
Time frame: 4 months post-augmentation
Implant site conditions
Time frame: 4 months post-augmentation
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 8 May 2026.
- Results publication: PubMed 9203100Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.
- Results publication: PubMed 9522974Ismail NM, Mustapha MS, Megat R. The subcellular localisation and the time course of bismuth in the gastric mucosa of rats after short-term administration of colloidal bismuth subcitrate. Ann Acad Med Singap. 1997 Nov;26(6):754-7.
- Results publication: PubMed 22211303Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
- Results publication: PubMed 19929956Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
- Results publication: PubMed 26566965Misawa M, Lindhe J, Araujo MG. The alveolar process following single-tooth extraction: a study of maxillary incisor and premolar sites in man. Clin Oral Implants Res. 2016 Jul;27(7):884-9. doi: 10.1111/clr.12710. Epub 2015 Nov 14.
- Results publication: PubMed 24966231Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25.
- Results publication: PubMed 28231347Corbella S, Taschieri S, Francetti L, Weinstein R, Del Fabbro M. Histomorphometric Results After Postextraction Socket Healing with Different Biomaterials: A Systematic Review of the Literature and Meta-Analysis. Int J Oral Maxillofac Implants. 2017 September/October;32(5):1001-1017. doi: 10.11607/jomi.5263. Epub 2017 Feb 23.
- Results publication: PubMed 29484712Jung RE, Ioannidis A, Hammerle CHF, Thoma DS. Alveolar ridge preservation in the esthetic zone. Periodontol 2000. 2018 Jun;77(1):165-175. doi: 10.1111/prd.12209. Epub 2018 Feb 27.
- Results publication: PubMed 30231083Bassir SH, Alhareky M, Wangsrimongkol B, Jia Y, Karimbux N. Systematic Review and Meta-Analysis of Hard Tissue Outcomes of Alveolar Ridge Preservation. Int J Oral Maxillofac Implants. 2018 Sep/Oct;33(5):979-994. doi: 10.11607/jomi.6399.
- Results publication: PubMed 32050833Avila-Ortiz G, Gubler M, Romero-Bustillos M, Nicholas CL, Zimmerman MB, Barwacz CA. Efficacy of Alveolar Ridge Preservation: A Randomized Controlled Trial. J Dent Res. 2020 Apr;99(4):402-409. doi: 10.1177/0022034520905660. Epub 2020 Feb 12.
- 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.
Yu-Cheng Chang, DMD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tooth Fractures and Tooth Extraction Status Nos, run by University of Pennsylvania at 1 site in United States.
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 5 inclusion and 8 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 8 May 2026. 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 United States. 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?
Ridge dimension changes before and after the augmentation. (time frame: from the date of the extraction 4 months). 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?
On the ClinicalTrials.gov record for NCT05505084, which also lists 10 linked publications.
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 8 May 2026.