Dental Implant Failure NosPhase 3NCT05156294
Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants
A Phase 3 study testing NovoMatrix in people with Dental Implant Failure Nos, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure Nos
- What is being tested?
- NovoMatrix
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jan 2022to 10 Aug 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Systemically healthy
- Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
- Need for one or two implants in the posterior mandible (maximum of three missing teeth).
- Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
- Non-smoker or smokers < 10 cig/day (self-reported).
- Ability to understand the study procedures and to comply with them to the entire length of the study.
Who cannot join
- Subjects with uncontrolled systemic diseases (ASA type III).
- Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
- Pregnant or lactating women.
- Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
- History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
- Local inflammation (including untreated periodontitis)
Show all 11Show fewer
- Severe bruxism or clenching habits.
- Any kind of bone augmentation performed on the implant site, with a healing period <6 months
- Less than 4 mm of keratinized mucosa
- Post-extraction sites with <12 weeks of healing
- Lack of primary implant stability assessed intrasurgically.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants. A Randomized Clinical Trial
The main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. The test hypothesis is that placing an acellular dermal matrix membrane simultaneous to implant placement in the posterior mandible, will increase the soft tissue thickness and consequently reduce the marginal bone level changes.
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up
Read the detailed description
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up. The randomization sequence will be created using a computer-generated list by an independent researcher. Allocation concealment will be kept by means of opaque sealed envelopes that will be open by one of the researchers during surgery, and revealed to the operator immediately after implant insertion.
All patients will receive standardized oral hygiene instructions consisting on the use of a manual or power-driven toothbrush and specific interdental brushes. Then, patients will be randomized to one of the following groups:
- Test Group :Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs)
- Control Group: All the procedures will be the same as in the Test Group, with the only difference that no attempt to thicken the mucosa with the acellular dermal matrix will be performed.
- Conditions
- Dental Implant Failure Nos
- Being tested
- NovoMatrix, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NovoMatrixDevice
Implants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).
ControlOther
Implants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs).
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). Receives: Device: NovoMatrix |
| Control | Other | Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in marginal alveolar crest
The primary outcome variable of this trial is the change in the marginal alveolar crest after the surgical intervention, assessed by the radiographic change of interproximal bone levels. It will be assessed with periapical radiographs, immediately after surgery and at 6 months and 12 months after loading, by means of computer image analysis software (Image J, National Institute of Health [NIH], Bethesda, Maryland). The calibration of the periapical radiographs will be performed using the distance between two implant threads or the length of the implant.
Measured: 1 year
Secondary outcomes (9)
Duration of surgical intervention.
Will be measured using the stopwatch, starting from the tooth extraction and ending with the suturing
Measured: from the tooth extraction to the end of the surgery
Wound healing
Will be assessed using Landry index
Measured: After a week
Change of keratinized tissue width
Will be measured from the soft tissue margin to the muco-gingival junction at the mid-buccal aspect.
Measured: 1 year
Change in peri-implant soft tissue thickness
Expressed in millimeters, measured by linear and volumetric analysis. The STL's representing the tissue contours at baseline, 2 months (M), 6M and 12M, will be superimposed to the DICOM files representing the hard tissue at baseline and 12M.
Measured: 1 year
Change of the peri-implant soft tissue health
Will be measured in six points at the implant of interest, using a University of North Carolina (UNC-15) periodontal probe.
Measured: 1 year
Interproximal recession
Will be measured as the distance in mm between the peak of the papilla and the incisal edge.
Measured: 1 year
Full-mouth plaque and bleeding scores
as the percentage of total surfaces (four aspects per tooth) that revealed plaque (Full mouth plaque score or FMPS, O'Leary et al., 1972) and bleeding on probing, respectively.
Absence or presence of plaque on each surface in the dentition will be recorded in dichotomous manner, with subsequent calculation of the full-mouth plaque score as percentage of the surfaces with plaque to the total number of surfaces assessed; similarly, full-mouth bleeding score will be calculated, assessing presence of bleeding upon gentle probing with standardized force of 0.25 Newtons (N).
Measured: 1 year
Patient-reported outcome measures for pain and discomfort
will be reported by assessing post-surgical morbidity and patient-reported experience measures (Tonetti et al., 2018); Patients will be instructed to use a post-operative diary for the first 14 days after the surgery to capture patient-reported experience measures.
The diary will be designed to assess patient recovery in four main areas: post-surgery sequelae, pain and discomfort, oral function and interference with daily activities. Patient perception of pain and discomfort will be rated using a Visual Analogue Scale (VAS) scale. Patients will be asked to report the number of tablets and days taken as painkillers or anti-inflammatory drugs.
Measured: 14 days
Patient Global Assessment
Apart from that, patient perception of the difficulty of surgical intervention, patient perception of pain during the procedure and patient preference for alternate therapy will be recorded at the end of the surgery, using the VAS scale.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start10 Jan 2022
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Dental Implant Failure NosStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- doubled-blind, parallel groups, randomized clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156294
- Sponsor's protocol ID
- 21/622-EC_P
- Status last verified
- May 2024
- First submitted
- 11 Nov 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Canullo L, Fedele GR, Iannello G, Jepsen S. Platform switching and marginal bone-level alterations: the results of a randomized-controlled trial. Clin Oral Implants Res. 2010 Jan;21(1):115-21. doi: 10.1111/j.1600-0501.2009.01867.x.
PubMed 20070752O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
PubMed 4500182Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.
PubMed 24673875
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Soft Tissue Augmentation With an Acellular Dermal Matrix in Marginal Bone Levels Around Implants. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05156294
- Acronym / sponsor ID
- 21/622-EC_P
- Conditions
- Dental Implant Failure Nos
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Aug 2024 (estimated)
- First posted
- 14 Dec 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 main objective of this study is to evaluate the efficacy of an acellular dermal matrix membrane to increase the peri-implant soft tissue thickness and to reduce marginal bone loss during non-submerged implant placement, as compared with the standard protocol for implant placement. The test hypothesis is that placing an acellular dermal matrix membrane simultaneous to implant placement in the posterior mandible, will increase the soft tissue thickness and consequently reduce the marginal bone level changes.
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up
Detailed description
The study is designed as a doubled-blind, parallel groups, randomized clinical trial with a 1-year follow-up. The randomization sequence will be created using a computer-generated list by an independent researcher. Allocation concealment will be kept by means of opaque sealed envelopes that will be open by one of the researchers during surgery, and revealed to the operator immediately after implant insertion.
All patients will receive standardized oral hygiene instructions consisting on the use of a manual or power-driven toothbrush and specific interdental brushes. Then, patients will be randomized to one of the following groups:
- Test Group :Mucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs)
- Control Group: All the procedures will be the same as in the Test Group, with the only difference that no attempt to thicken the mucosa with the acellular dermal matrix will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- doubled-blind, parallel groups, randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: NovoMatrixMucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). |
| Control | Other | Other: ControlMucoperiosteal flaps will be raised and the conventional drilling sequence for implants will be implemented (Camlog Conelog Screw-Line Promote Plus implants). Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Systemically healthy
- Periodontally healthy or with stable treated periodontitis and good oral hygiene (Full Mouth Plaque Score (FMPS) and Full Mouth Bleeding Score (FMBS) ≤ 15%, measured at six sites per tooth)
- Need for one or two implants in the posterior mandible (maximum of three missing teeth).
- Enough bone availability to place an implant with a minimum diameter of 3.8 mm and at least 7 mm length.
- Non-smoker or smokers < 10 cig/day (self-reported).
Key exclusion criteria (11 listed)
- Subjects with uncontrolled systemic diseases (ASA type III).
- Subjects taking medications with immunosuppressors, bisphosphonates or high doses of corticosteroids; current drug or alcohol use or dependence that could interfere with adherence to study requirements.
- Pregnant or lactating women.
- Allergy to collagen or analgesics/anti-inflammatory non-steroid drugs.
- History of cancer requiring radiotherapy or chemotherapy during the last 5 years.
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 |
|---|---|---|
| NovoMatrixImplants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Consecutively, 4 to 6 mm height healing abutments and the allogenic membrane (NovoMatrix®, BioHorizon) folded in two on top of the implant (secured with the healing abutment), will be placed. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). | Device | Test |
| ControlImplants of Camlog Conelog Screw-Line Promote Plus will be placed. Implants will be placed 1 mm below the bone crest. The diameter of the implant will be in the range of 3.8 and 4.3 mm. Finally, flaps will be sutured with 6/0 polypropylene monofilament. Patients will be instructed to rinse with 15 ml of 0.12% chlorhexidine (Perio-Aid tratamiento, Dentaid SL, Barcelona, Spain) 60 seconds twice per day until suture removal, that will take place 14 days later. Anti-inflammatory drugs will also be prescribed (Ibuprofen 600 mg every 8 hours upon patient´s needs). | Other | Control |
Primary outcome
Change in marginal alveolar crest
Time frame: 1 year
The primary outcome variable of this trial is the change in the marginal alveolar crest after the surgical intervention, assessed by the radiographic change of interproximal bone levels. It will be assessed with periapical radiographs, immediately after surgery and at 6 months and 12 months after loading, by means of computer image analysis software (Image J, National Institute of Health [NIH], Bethesda, Maryland). The calibration of the periapical radiographs will be performed using the distance between two implant threads or the length of the implant.
9 secondary outcomes
Duration of surgical intervention.
Time frame: from the tooth extraction to the end of the surgery
Wound healing
Time frame: After a week
Change of keratinized tissue width
Time frame: 1 year
Change in peri-implant soft tissue thickness
Time frame: 1 year
Change of the peri-implant soft tissue health
Time frame: 1 year
Interproximal recession
Time frame: 1 year
Full-mouth plaque and bleeding scores
Time frame: 1 year
Patient-reported outcome measures for pain and discomfort
Time frame: 14 days
Patient Global Assessment
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Background: PubMed 20070752Canullo L, Fedele GR, Iannello G, Jepsen S. Platform switching and marginal bone-level alterations: the results of a randomized-controlled trial. Clin Oral Implants Res. 2010 Jan;21(1):115-21. doi: 10.1111/j.1600-0501.2009.01867.x.
- Background: PubMed 4500182O'Leary TJ, Drake RB, Naylor JE. The plaque control record. J Periodontol. 1972 Jan;43(1):38. doi: 10.1902/jop.1972.43.1.38. No abstract available.
- Background: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Background: PubMed 24673875Linkevicius T, Puisys A, Steigmann M, Vindasiute E, Linkeviciene L. Influence of Vertical Soft Tissue Thickness on Crestal Bone Changes Around Implants with Platform Switching: A Comparative Clinical Study. Clin Implant Dent Relat Res. 2015 Dec;17(6):1228-36. doi: 10.1111/cid.12222. Epub 2014 Mar 28.
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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.
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 Phase 3 study testing NovoMatrix in people with Dental Implant Failure Nos, run by Universidad Complutense de Madrid 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 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change in marginal alveolar crest (time frame: 1 year). 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 NCT05156294, which also lists 4 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 2024.