Tooth Extraction Site HealingNCT07589751
Biomaterials Exposed to Oral Environment: Which One is the Appropriate Option?
A study testing Alveolar Ridge Reconstruction in people with Tooth Extraction Site Healing and Alveolar Ridge Preservation, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
Trial summary
After tooth extraction, bone loss can compromise future dental implant treatment. Dentists often use biomaterials to preserve bone, but in many cases these materials are left exposed to the oral environment, where saliva and bacteria may affect healing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction Site Healing, Alveolar Ridge Preservation
- What is being tested?
- Alveolar Ridge Reconstruction
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 5 May 2026to Dec 2027
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.
- > 18 years of age
- non-molar tooth indicated for extraction
- intact sockets upon extractions
- Patients using removable provisional prosthesis (accessible to remove possible contact with surgical site) or patients without prosthesis after tooth extraction.
Who cannot join
- Current smokers
- Uncontrolled Diabetes Mellitus
- Mandibular incisors
- Patients receiving chemo or radiotherapy or history of these treatments in the previous 5 years
- Any other disease or medications that may compromise normal wound healing
- Unwilling or unable to sing the informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
After tooth extraction, bone loss can compromise future dental implant treatment. Dentists often use biomaterials to preserve bone, but in many cases these materials are left exposed to the oral environment, where saliva and bacteria may affect healing. This study will investigate how different collagen-based biomaterials behave when exposed in the mouth, evaluating healing, bone changes, bacterial contamination, and patient experience. Sixty patients will be included in a randomized clinical trial comparing two commonly used biomaterials and natural healing. The results will help clinicians choose safer and more effective treatments, improving outcomes for patients undergoing tooth extraction and future implant rehabilitation.
Read the detailed description
- Ethical considerations and patient selection This study will be previously submitted to the ethical committee of PUCRS - Brazil for appreciation and evaluation following the international ethical guidelines for clinical studies. Following ethical acceptance, patients needing non-molar tooth extraction with four/three walls of alveolar integrity will be selected for this study. Exclusion and inclusion criteria will be applied in the patient's selection according to potential systemic diseases and external habits that influence bone regeneration. (please, check inclusion and exclusion criteria).
- Surgical procedures and group division Following patient selection, minimal invasive extractions will be performed and standard alveolar preservation will be done using Bio-oss Collagen® - Geistlich for alveolar filling and (BioGide® or Mucograft® Seal - Geistlich, depending on the study group) for covering the gap-filling procedure showing one biomaterial side exposed to the oral cavity environment. The patients will be divided randomly into three experimental groups of 20 patients each, completing 60 patients. One group will receive alveolar preservation with Bio-oss Collagen® + BioGide® and the other group will receive alveolar preservation with Bio-oss Collagen® + Mucograft® Seal. A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction. Evaluation time points will be named T0, T1, T2, T3 (T0 = immediate after surgery, T1 = 1 week, T2 = 3 weeks, T3 = 3 months). After surgeries, patients will receive detailed verbal and written post-operative instructions, prescriptions for anti-inflammatory medication (ibuprofen 600 mg for 3 days, if needed), and antibiotic therapy (amoxicillin 500 mg every 8h for 7 days or, in case of penicillin allergy, clindamycin 300 mg every 6h for 7 days). Patients will be recalled at 1 (T1), 3 weeks (T2), and after three months (T3). Sutures were removed at 1 week. Patients will be advised to not use mouth rinses in order to not compromise the surgical procedure. Normal hygiene using toothbrushes and toothpastes will be indicated to the patients to maintain clean conditions. Following surgical procedures, the surgical sites will be evaluated regarding biomaterial contamination, clinical tissue healing, and radiographic conditions.
- Biomaterial surface contamination For biomaterial contamination, a sterilized swab for bacterial analysis will be used directly over the procedure (per patient/per time) for investigation of potential biomaterial surface contamination at T0, T1, and T2. Following this, the bacterial collection will be processed and evaluated at the Microbiological laboratory. The potential bacterial collection will be spread in agar plates and cultured in a stove under appropriate bacteria conditions for 24 hours. Bacteria colonies will be evaluated and counted comparing the proposed groups and time points in this study. A control collection will be performed before the surgical procedure in the tooth extraction region using a sterilized swab to evaluate the previous microbiome and similarities to the post-surgery evaluations.
- Radiographic evaluation For radiographic investigation, digital periapical radiographs will be performed on pre-operatory days (for diagnostics of tooth extraction); at T1 and T3, evaluating potential procedure failures or infiltration by comparing the time points. Measurements will be performed digitally using the radiographic software associated with the X-ray to investigate regenerated bone and possible bacterial infiltration comparing the groups.
- Qualitative and quantitative clinical outcomes Early clinical healing will be evaluated at three different times (T0, T1, T2, T3) through clinical observation and alveolar measurements using a periodontal probe in millimeters. Linear alveolar size and soft tissue contour measurements will be evaluated using a periodontal probe (measuring the mesio-distal and buccal-lingual/palatal distance in millimeters) according to the alveolo size and possible alveolo changes, directly after tooth extraction, at T0, T1, T2, and T3. Additionally, qualitative photographs will be performed for evaluation of early tissue healing, possible infection, possible failures, and/or dehiscence.
- Patient-reported outcome measures Patients will be asked to rate their level of post-operative discomfort and overall satisfaction after alveolar ridge preservation at T0, T1, T2 and T3. The questionnaire will be applied using a simple table with a 100-point visual analogue scale where the patient will be able to select from 0 to 100 (0 for worst evaluation and 100 for the higher evaluation). (Couso-Queiruga et al. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: a randomized clinical trial. Journal of clinical periodontology, 50(2), 132-146, 2023).
- Statistical analysis The data will be analyzed using one-way ANOVA, followed by post hoc testing Tukey HSD test if necessary, comparing the three experimental groups in the three different time points. Bacterial assays will be performed in triplicate for each time point. A significant variation between groups was considered to occur at 5% (p < 0.05).
- Being tested
- Alveolar Ridge Reconstruction
- Keywords
- alveolar preservation, bone regeneration, biomaterials
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge ReconstructionProcedure or surgery
Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment.
Alveolar Ridge ReconstructionProcedure or surgery
ARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment.
| Study group | Role | What they receive |
|---|---|---|
| Negative control group | No intervention | A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction. |
| Group test 1 | Experimental | Alveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment. Receives: Procedure: Alveolar Ridge Reconstruction |
| Group test 2 | Experimental | Alveolar ridge preservation using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment. Receives: Procedure: Alveolar Ridge Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar dimension changes (millimetres)
To compare the alveolar dimensions (vertically and horizontally) in millimetres of two different approaches using biomaterials (collagen membrane vs. collagen matrix) when intentionally exposed to the oral environment after an alveolar preservation procedure without primary closure, and a negative control without alveolar preservation. These measures will be done using periodontal probes by a trained and calibrated evaluator.
Measured: From the surgery to the last follow-up at 3 months
Secondary outcomes (3)
Biomaterial contamination (colony count - bacterial colony number)
To compare the number of colonies formed after contamination collection with swabs on the surfaces of two different biomaterials (collagen membrane vs collagen matrix) when intentionally exposed to the oral environment following an alveolar preservation procedure without primary closure. The number of colonies will be counted with a microscope and tabulated in accordance with microbiological standards.
Measured: Immediately after surgery to 21 days of follow-up
Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres
A radiographic comparison of the alveolar dimension changes between the three groups will be done using digital periapical radiographs and a digital ruler in the radiographic software to measure the alveolar dimensions (vertically and horizontally) in millimetres after the surgical procedures.
Measured: From the surgery to the last follow-up at 3 months
Patient-related outcomes (OHIP-49 and VAS questionnaires) - score
To investigate the quality of life measurements using the OHIP-49 questionnaire and to measure pain using the VAS scale questionnaire after the surgical interventions. These questionnaires have a scale pointing 1 to 5, which generates a score for each question. Therefore, the measure will be a final score at each time point.
Measured: From the surgery to the last follow-up at 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start5 May 2026
- Primary completionJul 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Tooth Extraction Site HealingStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Collaborators
- Geistlich Pharma AG
- Responsible party
- Principal investigator, Marcel Ferreira Kunrath, Pontificia Universidade Católica do Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07589751
- Sponsor's protocol ID
- CAAE 92555525.3.0000.5336
- Other IDs
- MTA 24-209
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Barootchi S, Tavelli L, Majzoub J, Stefanini M, Wang HL, Avila-Ortiz G. Alveolar ridge preservation: Complications and cost-effectiveness. Periodontol 2000. 2023 Jun;92(1):235-262. doi: 10.1111/prd.12469. Epub 2022 Dec 29.
PubMed 36580417Kunrath MF, Dahlin C. The Impact of Early Saliva Interaction on Dental Implants and Biomaterials for Oral Regeneration: An Overview. Int J Mol Sci. 2022 Feb 11;23(4):2024. doi: 10.3390/ijms23042024.
PubMed 35216139Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.
PubMed 36345818Kunrath MF, Giraldo-Osorno PM, Mendes K, Gomes ATPC, Rosa N, Barros M, Dahlin C. Unveiling the consequences of early human saliva contamination on membranes for guided bone regeneration. J Periodontal Res. 2024 Dec;59(6):1196-1209. doi: 10.1111/jre.13266. Epub 2024 Apr 22.
PubMed 38644743Buser D, Urban I, Monje A, Kunrath MF, Dahlin C. Guided bone regeneration in implant dentistry: Basic principle, progress over 35 years, and recent research activities. Periodontol 2000. 2023 Oct;93(1):9-25. doi: 10.1111/prd.12539.
PubMed 38194351
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomaterials Exposed to Oral Environment: Which One is the Appropriate Option?
- ClinicalTrials.gov ID
- NCT07589751
- Acronym / sponsor ID
- CAAE 92555525.3.0000.5336
- Keywords
- alveolar preservation, bone regeneration, biomaterials
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Pontificia Universidade Católica do Rio Grande do SulUniversity, hospital or other
- Collaborators
- Geistlich Pharma AG
- Study start
- 5 May 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 15 May 2026 (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.
After tooth extraction, bone loss can compromise future dental implant treatment. Dentists often use biomaterials to preserve bone, but in many cases these materials are left exposed to the oral environment, where saliva and bacteria may affect healing. This study will investigate how different collagen-based biomaterials behave when exposed in the mouth, evaluating healing, bone changes, bacterial contamination, and patient experience. Sixty patients will be included in a randomized clinical trial comparing two commonly used biomaterials and natural healing. The results will help clinicians choose safer and more effective treatments, improving outcomes for patients undergoing tooth extraction and future implant rehabilitation.
Detailed description
- Ethical considerations and patient selection This study will be previously submitted to the ethical committee of PUCRS - Brazil for appreciation and evaluation following the international ethical guidelines for clinical studies. Following ethical acceptance, patients needing non-molar tooth extraction with four/three walls of alveolar integrity will be selected for this study. Exclusion and inclusion criteria will be applied in the patient's selection according to potential systemic diseases and external habits that influence bone regeneration. (please, check inclusion and exclusion criteria).
- Surgical procedures and group division Following patient selection, minimal invasive extractions will be performed and standard alveolar preservation will be done using Bio-oss Collagen® - Geistlich for alveolar filling and (BioGide® or Mucograft® Seal - Geistlich, depending on the study group) for covering the gap-filling procedure showing one biomaterial side exposed to the oral cavity environment. The patients will be divided randomly into three experimental groups of 20 patients each, completing 60 patients. One group will receive alveolar preservation with Bio-oss Collagen® + BioGide® and the other group will receive alveolar preservation with Bio-oss Collagen® + Mucograft® Seal. A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction. Evaluation time points will be named T0, T1, T2, T3 (T0 = immediate after surgery, T1 = 1 week, T2 = 3 weeks, T3 = 3 months). After surgeries, patients will receive detailed verbal and written post-operative instructions, prescriptions for anti-inflammatory medication (ibuprofen 600 mg for 3 days, if needed), and antibiotic therapy (amoxicillin 500 mg every 8h for 7 days or, in case of penicillin allergy, clindamycin 300 mg every 6h for 7 days). Patients will be recalled at 1 (T1), 3 weeks (T2), and after three months (T3). Sutures were removed at 1 week. Patients will be advised to not use mouth rinses in order to not compromise the surgical procedure. Normal hygiene using toothbrushes and toothpastes will be indicated to the patients to maintain clean conditions. Following surgical procedures, the surgical sites will be evaluated regarding biomaterial contamination, clinical tissue healing, and radiographic conditions.
- Biomaterial surface contamination For biomaterial contamination, a sterilized swab for bacterial analysis will be used directly over the procedure (per patient/per time) for investigation of potential biomaterial surface contamination at T0, T1, and T2. Following this, the bacterial collection will be processed and evaluated at the Microbiological laboratory. The potential bacterial collection will be spread in agar plates and cultured in a stove under appropriate bacteria conditions for 24 hours. Bacteria colonies will be evaluated and counted comparing the proposed groups and time points in this study. A control collection will be performed before the surgical procedure in the tooth extraction region using a sterilized swab to evaluate the previous microbiome and similarities to the post-surgery evaluations.
- Radiographic evaluation For radiographic investigation, digital periapical radiographs will be performed on pre-operatory days (for diagnostics of tooth extraction); at T1 and T3, evaluating potential procedure failures or infiltration by comparing the time points. Measurements will be performed digitally using the radiographic software associated with the X-ray to investigate regenerated bone and possible bacterial infiltration comparing the groups.
- Qualitative and quantitative clinical outcomes Early clinical healing will be evaluated at three different times (T0, T1, T2, T3) through clinical observation and alveolar measurements using a periodontal probe in millimeters. Linear alveolar size and soft tissue contour measurements will be evaluated using a periodontal probe (measuring the mesio-distal and buccal-lingual/palatal distance in millimeters) according to the alveolo size and possible alveolo changes, directly after tooth extraction, at T0, T1, T2, and T3. Additionally, qualitative photographs will be performed for evaluation of early tissue healing, possible infection, possible failures, and/or dehiscence.
- Patient-reported outcome measures Patients will be asked to rate their level of post-operative discomfort and overall satisfaction after alveolar ridge preservation at T0, T1, T2 and T3. The questionnaire will be applied using a simple table with a 100-point visual analogue scale where the patient will be able to select from 0 to 100 (0 for worst evaluation and 100 for the higher evaluation). (Couso-Queiruga et al. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: a randomized clinical trial. Journal of clinical periodontology, 50(2), 132-146, 2023).
- Statistical analysis The data will be analyzed using one-way ANOVA, followed by post hoc testing Tukey HSD test if necessary, comparing the three experimental groups in the three different time points. Bacterial assays will be performed in triplicate for each time point. A significant variation between groups was considered to occur at 5% (p < 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Negative control group | No intervention | –A negative control group will be applied without any type of alveolar preservation, only minimally invasive extraction. |
| Group test 1 | Experimental | Procedure: Alveolar Ridge ReconstructionAlveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment. |
| Group test 2 | Experimental | Procedure: Alveolar Ridge ReconstructionAlveolar ridge preservation using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult subjects in need of non-molar maxillary or mandibular single tooth extraction at the PUCRS university - Porto Alegre - Brazil.
Key exclusion criteria (6 listed)
- Current smokers
- Uncontrolled Diabetes Mellitus
- Mandibular incisors
- Patients receiving chemo or radiotherapy or history of these treatments in the previous 5 years
- Any other disease or medications that may compromise normal wound healing
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 |
|---|---|---|
| Alveolar Ridge ReconstructionAlveolar ridge preservation (ARP) using Bio-Oss Collagen® + Bio-Gide® exposed to the oral environment. | Procedure or surgery | Group test 1 |
| Alveolar Ridge ReconstructionARP using Bio-Oss Collagen® + Mucograft® Seal® exposed to the oral environment. | Procedure or surgery | Group test 2 |
Primary outcome
Alveolar dimension changes (millimetres)
Time frame: From the surgery to the last follow-up at 3 months
To compare the alveolar dimensions (vertically and horizontally) in millimetres of two different approaches using biomaterials (collagen membrane vs. collagen matrix) when intentionally exposed to the oral environment after an alveolar preservation procedure without primary closure, and a negative control without alveolar preservation. These measures will be done using periodontal probes by a trained and calibrated evaluator.
3 secondary outcomes
Biomaterial contamination (colony count - bacterial colony number)
Time frame: Immediately after surgery to 21 days of follow-up
Radiographic alveolar bone dimensions (vertical and horizontal measures) in millimetres
Time frame: From the surgery to the last follow-up at 3 months
Patient-related outcomes (OHIP-49 and VAS questionnaires) - score
Time frame: From the surgery to the last follow-up at 3 months.
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 17 Sep 2026.
- Background: PubMed 36580417Barootchi S, Tavelli L, Majzoub J, Stefanini M, Wang HL, Avila-Ortiz G. Alveolar ridge preservation: Complications and cost-effectiveness. Periodontol 2000. 2023 Jun;92(1):235-262. doi: 10.1111/prd.12469. Epub 2022 Dec 29.
- Background: PubMed 35216139Kunrath MF, Dahlin C. The Impact of Early Saliva Interaction on Dental Implants and Biomaterials for Oral Regeneration: An Overview. Int J Mol Sci. 2022 Feb 11;23(4):2024. doi: 10.3390/ijms23042024.
- Background: PubMed 36345818Couso-Queiruga E, Weber HA, Garaicoa-Pazmino C, Barwacz C, Kalleme M, Galindo-Moreno P, Avila-Ortiz G. Influence of healing time on the outcomes of alveolar ridge preservation using a collagenated bovine bone xenograft: A randomized clinical trial. J Clin Periodontol. 2023 Feb;50(2):132-146. doi: 10.1111/jcpe.13744. Epub 2022 Nov 18.
- Background: PubMed 38644743Kunrath MF, Giraldo-Osorno PM, Mendes K, Gomes ATPC, Rosa N, Barros M, Dahlin C. Unveiling the consequences of early human saliva contamination on membranes for guided bone regeneration. J Periodontal Res. 2024 Dec;59(6):1196-1209. doi: 10.1111/jre.13266. Epub 2024 Apr 22.
- Background: PubMed 38194351Buser D, Urban I, Monje A, Kunrath MF, Dahlin C. Guided bone regeneration in implant dentistry: Basic principle, progress over 35 years, and recent research activities. Periodontol 2000. 2023 Oct;93(1):9-25. doi: 10.1111/prd.12539.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar Ridge Reconstruction in people with Tooth Extraction Site Healing and Alveolar Ridge Preservation, run by Pontificia Universidade Católica do Rio Grande do Sul at 1 site in Brazil.
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 6 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 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 Brazil. 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?
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?
Alveolar dimension changes (millimetres) (time frame: From the surgery to the last follow-up at 3 months). 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 NCT07589751, which also lists 5 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 17 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.