Dental ImplantNCT04803110
Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques
A study testing Dental implant placement after tooth extraction in people with Dental Implant and Tooth Extraction, run by Aula Dental Avanzada at 1 site in Spain.
Trial summary
The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques. These techniques are: the Socket-Shield technique and conventional immediate placement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dental Implant, Tooth Extraction, Bone Resorption
- What is being tested?
- Dental implant placement after tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2021to 1 Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw.
- Teeth that do not present alteration or loss of the vestibular bone table.
Who cannot join
- Patients in whom surgical intervention is contraindicated.
- Teeth with alteration or loss of the vestibular bone table.
- Teeth with marginal recession >2mm.
- Early or delayed failure of the implant placed with any of the three techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.
The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques.
These techniques are: the Socket-Shield technique and conventional immediate placement.
Read more
The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique.
From a sample of 20 patients, they will be divided into groups of 10 and will be randomized using the random.org program.
The soft tissue volume will be digitally recorded by intraoral scanning before tooth extraction and 6 months later.
The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.
Read the detailed description
After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex.
This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower.
To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing.
The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant.
Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down.
The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies.
From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction.
On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed.
A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases.
In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction.
Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes.
A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector.
Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.
- Conditions
- Dental Implant, Tooth Extraction, Bone Resorption
- Being tested
- Dental implant placement after tooth extraction
- Keywords
- Postextraction implant, Implant type 1, Socket-Shield, Soft Tissue volume, RCT
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placement after tooth extractionProcedure or surgery
Also called Implant surgery
Immediate implant placement after partial or complete tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Implant with SST (SST) | Experimental | Patients who will receive immediate implant placement using the Socket-Shield Technique. Receives: Procedure: Dental implant placement after tooth extraction |
| Immediate Implant with biomaterial (GAP) | Active comparator | Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth. Receives: Procedure: Dental implant placement after tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue volume
Soft tissue volume changes after tooth extraction
Measured: 6 months
Secondary outcomes (5)
Surgery pain perception by Numerical Rating Scale
Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain.
Measured: Just after surgery
Surgery satisfaction of the patient by Numerical Rating Scale
Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied
Measured: Just after surgery
General satisfaction of the patient by Numerical Rating Scale
Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied
Measured: 6 months after the beginning of treatment
Esthetic satisfaction of the patient by Numerical Rating Scale
Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
Measured: 3 months after after crown placement
Function satisfaction of the patient by Numerical Rating Scale
Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
Measured: 3 months after after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start1 Mar 2021
- Primary completion25 Dec 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Model description
- 10 receiving immediate implant placement with Socket-Shield Technique and 10 receiving immediate implant placement with complete extraction of the tooth. (n=20)
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, Principal investigator, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04803110
- Sponsor's protocol ID
- POSTEXO
- Status last verified
- Aug 2025
- First submitted
- 13 Mar 2021
- Last updated
- 19 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share with other researches.
Publications
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
PubMed 24660198Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
PubMed 24894299Buser D, Chen ST, Weber HP, Belser UC. Early implant placement following single-tooth extraction in the esthetic zone: biologic rationale and surgical procedures. Int J Periodontics Restorative Dent. 2008 Oct;28(5):441-51.
PubMed 18990995Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.
PubMed 20712701Cosyn J, De Lat L, Seyssens L, Doornewaard R, Deschepper E, Vervaeke S. The effectiveness of immediate implant placement for single tooth replacement compared to delayed implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:224-241. doi: 10.1111/jcpe.13054.
PubMed 30624808Seyssens L, De Lat L, Cosyn J. Immediate implant placement with or without connective tissue graft: A systematic review and meta-analysis. J Clin Periodontol. 2021 Feb;48(2):284-301. doi: 10.1111/jcpe.13397. Epub 2020 Nov 20.
PubMed 33125754Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.
PubMed 29333449Baumer D, Zuhr O, Rebele S, Schneider D, Schupbach P, Hurzeler M. The socket-shield technique: first histological, clinical, and volumetrical observations after separation of the buccal tooth segment - a pilot study. Clin Implant Dent Relat Res. 2015 Feb;17(1):71-82. doi: 10.1111/cid.12076. Epub 2013 Apr 30.
PubMed 23631704Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
PubMed 28333394Barbisan A, Dias CS, Bavia PF, Sapata VM, Cesar-Neto JB, Silva CO. Soft Tissues Changes After Immediate and Delayed Single Implant Placement in Esthetic Area: A Systematic Review. J Oral Implantol. 2015 Oct;41(5):612-9. doi: 10.1563/AAID-JOI-D-13-00095. Epub 2014 Jan 29.
PubMed 24475930Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.
PubMed 27978602Huynh-Ba G, Hoders AB, Meister DJ, Prihoda TJ, Mills MP, Mealey BL, Cochran DL. Esthetic, clinical, and radiographic outcomes of two surgical approaches for single implant in the esthetic area: 1-year results of a randomized controlled trial with parallel design. Clin Oral Implants Res. 2019 Aug;30(8):745-759. doi: 10.1111/clr.13458. Epub 2019 Jun 7.
PubMed 31099929Bramanti E, Norcia A, Cicciu M, Matacena G, Cervino G, Troiano G, Zhurakivska K, Laino L. Postextraction Dental Implant in the Aesthetic Zone, Socket Shield Technique Versus Conventional Protocol. J Craniofac Surg. 2018 Jun;29(4):1037-1041. doi: 10.1097/SCS.0000000000004419.
PubMed 29489581
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT04803110
- Acronym / sponsor ID
- POSTEXO
- Conditions
- Dental Implant, Tooth Extraction, Bone Resorption
- Keywords
- Postextraction implant, Implant type 1, Socket-Shield, Soft Tissue volume, RCT
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Dec 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 17 Mar 2021 (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.
The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques.
These techniques are: the Socket-Shield technique and conventional immediate placement.
The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique.
From a sample of 20 patients, they will be divided into groups of 10 and will be randomized using the random.org program.
The soft tissue volume will be digitally recorded by intraoral scanning before tooth extraction and 6 months later.
The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.
Detailed description
After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex.
This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower.
To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing.
The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant.
Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down.
The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies.
From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction.
On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed.
A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases.
In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction.
Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes.
A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector.
Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 receiving immediate implant placement with Socket-Shield Technique and 10 receiving immediate implant placement with complete extraction of the tooth. (n=20)
| Arm | Type | Receives |
|---|---|---|
| Immediate Implant with SST (SST) | Experimental | Procedure: Dental implant placement after tooth extractionPatients who will receive immediate implant placement using the Socket-Shield Technique. |
| Immediate Implant with biomaterial (GAP) | Active comparator | Procedure: Dental implant placement after tooth extractionPatients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw.
- Teeth that do not present alteration or loss of the vestibular bone table.
Key exclusion criteria (4 listed)
- Patients in whom surgical intervention is contraindicated.
- Teeth with alteration or loss of the vestibular bone table.
- Teeth with marginal recession >2mm.
- Early or delayed failure of the implant placed with any of the three techniques.
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 |
|---|---|---|
| Dental implant placement after tooth extractionAlso: Implant surgeryImmediate implant placement after partial or complete tooth extraction. | Procedure or surgery | Immediate Implant with SST (SST), Immediate Implant with biomaterial (GAP) |
Primary outcome
Soft tissue volume
Time frame: 6 months
Soft tissue volume changes after tooth extraction
5 secondary outcomes
Surgery pain perception by Numerical Rating Scale
Time frame: Just after surgery
Surgery satisfaction of the patient by Numerical Rating Scale
Time frame: Just after surgery
General satisfaction of the patient by Numerical Rating Scale
Time frame: 6 months after the beginning of treatment
Esthetic satisfaction of the patient by Numerical Rating Scale
Time frame: 3 months after after crown placement
Function satisfaction of the patient by Numerical Rating Scale
Time frame: 3 months after after crown placement
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 19 Aug 2025.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 24660198Chen ST, Buser D. Esthetic outcomes following immediate and early implant placement in the anterior maxilla--a systematic review. Int J Oral Maxillofac Implants. 2014;29 Suppl:186-215. doi: 10.11607/jomi.2014suppl.g3.3.
- Background: PubMed 24894299Lee CT, Chiu TS, Chuang SK, Tarnow D, Stoupel J. Alterations of the bone dimension following immediate implant placement into extraction socket: systematic review and meta-analysis. J Clin Periodontol. 2014 Sep;41(9):914-26. doi: 10.1111/jcpe.12276. Epub 2014 Jul 23.
- Background: PubMed 18990995Buser D, Chen ST, Weber HP, Belser UC. Early implant placement following single-tooth extraction in the esthetic zone: biologic rationale and surgical procedures. Int J Periodontics Restorative Dent. 2008 Oct;28(5):441-51.
- Background: PubMed 20712701Hurzeler MB, Zuhr O, Schupbach P, Rebele SF, Emmanouilidis N, Fickl S. The socket-shield technique: a proof-of-principle report. J Clin Periodontol. 2010 Sep;37(9):855-62. doi: 10.1111/j.1600-051X.2010.01595.x.
- Background: PubMed 30624808Cosyn J, De Lat L, Seyssens L, Doornewaard R, Deschepper E, Vervaeke S. The effectiveness of immediate implant placement for single tooth replacement compared to delayed implant placement: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:224-241. doi: 10.1111/jcpe.13054.
- Results publication: PubMed 33125754Seyssens L, De Lat L, Cosyn J. Immediate implant placement with or without connective tissue graft: A systematic review and meta-analysis. J Clin Periodontol. 2021 Feb;48(2):284-301. doi: 10.1111/jcpe.13397. Epub 2020 Nov 20.
- Results publication: PubMed 29333449Mitsias ME, Siormpas KD, Kotsakis GA, Ganz SD, Mangano C, Iezzi G. The Root Membrane Technique: Human Histologic Evidence after Five Years of Function. Biomed Res Int. 2017;2017:7269467. doi: 10.1155/2017/7269467. Epub 2017 Nov 22.
- Results publication: PubMed 23631704Baumer D, Zuhr O, Rebele S, Schneider D, Schupbach P, Hurzeler M. The socket-shield technique: first histological, clinical, and volumetrical observations after separation of the buccal tooth segment - a pilot study. Clin Implant Dent Relat Res. 2015 Feb;17(1):71-82. doi: 10.1111/cid.12076. Epub 2013 Apr 30.
- Results publication: PubMed 28333394Baumer D, Zuhr O, Rebele S, Hurzeler M. Socket Shield Technique for immediate implant placement - clinical, radiographic and volumetric data after 5 years. Clin Oral Implants Res. 2017 Nov;28(11):1450-1458. doi: 10.1111/clr.13012. Epub 2017 Mar 23.
- Results publication: PubMed 24475930Barbisan A, Dias CS, Bavia PF, Sapata VM, Cesar-Neto JB, Silva CO. Soft Tissues Changes After Immediate and Delayed Single Implant Placement in Esthetic Area: A Systematic Review. J Oral Implantol. 2015 Oct;41(5):612-9. doi: 10.1563/AAID-JOI-D-13-00095. Epub 2014 Jan 29.
- Results publication: PubMed 27978602Tonetti MS, Cortellini P, Graziani F, Cairo F, Lang NP, Abundo R, Conforti GP, Marquardt S, Rasperini G, Silvestri M, Wallkamm B, Wetzel A. Immediate versus delayed implant placement after anterior single tooth extraction: the timing randomized controlled clinical trial. J Clin Periodontol. 2017 Feb;44(2):215-224. doi: 10.1111/jcpe.12666. Epub 2017 Jan 31.
- Individual participant dataSharing planned: No. No plan to share with other researches.
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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.
Guillem Esteve-Pardo principal investigator
Aula Dental Avanzada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement after tooth extraction in people with Dental Implant and Tooth Extraction, run by Aula Dental Avanzada at 1 site in Spain.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 19 Aug 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 Spain. 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?
Soft tissue volume (time frame: 6 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 NCT04803110, which also lists 14 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 19 Aug 2025.