Alveolar Bone LossNCT02617212
Implant Abutment Dis-/Reconnection and Peri-Implant Marginal Bone Loss.
A study testing Implant surgery, Three abutment dis-/reconnections. and No abutment dis-/reconnections. in people with Alveolar Bone Loss, run by Fortaleza University at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Implant surgery, Three abutment dis-/reconnections. and No abutment dis-/reconnections.
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Nov 2015to May 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Partially edentulous patients requiring dental implant treatment for one or two dental units;
- Occlusal stability and regular occlusal plane;
- Enough space for implant and prosthesis;
- Good periodontal health
- Keratinized mucosa width > 4mm;
- Implant primary stability > 65 ISQ and insertion torque > 20Ncm;
Who cannot join
- Diabetes mellitus;
- Treatment with bisphosphonates;
- Head and neck irradiation;
- General contraindications to oral surgery;
- Pregnancy;
- Bone graft;
- Bruxism;
- Smoking habits.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fortaleza University; Health Sciences Center; School of Dentistry.
Fortaleza, Ceará, 60811-905
About this study
Official title: Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.
The purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.
Read the detailed description
The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times.
Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry.
The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants.
A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe.
The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm.
The implants should develop a final insertion torque of 32Ncm or above to enable abutment connection torque, indicated at the experimental arm. The implant primary stability will be also measured by resonance frequency analysis (Osstell; Osstell AB, Gothenburg, Sweden). A minimum 65 ISQ will be required to a single-stage surgery. Thus, those implants that do not contemplate these requirements will be excluded from the study and will receive a conventional treatment with two-stage surgery if necessary.
Before finishing the surgical procedure, the volunteers will be randomly assigned to one of the two arms by opening sealed envelopes with a random sequence generated by Excel (Microsoft, Redmond, Washington, USA). Therefore, the surgeon will identify each volunteer's arm only after the end of drilling, insertion and stabilization of the implants.
Each implant allocated at the control arm (active comparator) will receive conventional treatment with three abutment disconnections and reconnections. At the experimental arm, each implant will receive the prosthetic abutment in a definitive way immediately at the surgical procedure, avoiding any abutment disconnection.
The surgeries of both arms will be finished with suture, drug prescription and postoperative recommendations. All implants will receive temporary crowns at three months and definitive prosthesis until six months after surgery.
Intraoral radiographs will be done with paralleling technique immediately after surgery (baseline) and at 3, 6, 12 and 24 months later. The radiographs will have its dimensions corrected at the ImageJ software (National Institutes of Health, Bethesda, Maryland, USA) having implant known dimensions as reference.
Each implant will have its radiographs evaluated by a previously calibrated examiner with a minimum of 0.8 intra-rater reliability for the intraclass correlation coefficient. The examiner will not know to which arm the X-rays belong.
Primary and secondary outcomes data will be submitted to normality test and compared using statistical tests for paired and unpaired samples.
- Conditions
- Alveolar Bone Loss
- Being tested
- Implant surgery, Three abutment dis-/reconnections., No abutment dis-/reconnections.
- Keywords
- dental implant, bone preservation, definitive abutment, one abutment one time
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant surgeryProcedure or surgery
The volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm.
Three abutment dis-/reconnections.Device
At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque.
No abutment dis-/reconnections.Device
Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery.
| Study group | Role | What they receive |
|---|---|---|
| Definitive abutment | Experimental | Implant surgery. No abutment dis-/reconnections. Receives: Procedure: Implant surgery; Device: No abutment dis-/reconnections. |
| Conventional treatment | Active comparator | Implant surgery. Three abutment dis-/reconnections. Receives: Procedure: Implant surgery; Device: Three abutment dis-/reconnections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant marginal bone level change.
To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.
Measured: 2, 6, 12 and 24 months after implant surgery.
Secondary outcomes (4)
Implant stability change.
The implant stability will be measured using a resonance frequency analysis equipment to confirm the implant osseointegration.
Measured: 3 and 6 months after implant surgery.
Gingival level change.
The gingival level will be measured using a periodontal probe and an acrylic stent as a reference.
Measured: 6, 12 and 24 months after implant surgery.
Peri-implant probing depth change.
To evaluate the peri-implant health, the probing depth will be assessed in 6 areas around the implant using the prosthetic abutment as a reference.
Measured: 12 and 24 months after implant surgery.
Bleeding on probing change.
To evaluate the peri-implant health, the bleeding on probing will be observer or not at until 10 seconds after peri-implant probing.
Measured: 12 and 24 months after implant surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study start1 Nov 2015
- Primary completionMay 2018
- Study completionMay 2018
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 Alveolar Bone LossStudies 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
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fortaleza University
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade Federal do Ceara
- Responsible party
- Principal investigator, Luciano de Freitas Guimarães Praça, Fortaleza University
- Investigators
- Rodrigo O. Rego, PhD, Study director, Universidade Federal do Ceara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617212
- Sponsor's protocol ID
- 1.310.562
- Status last verified
- May 2024
- First submitted
- 19 Nov 2015
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
PubMed 6809663Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955Abrahamsson I, Berglundh T, Lindhe J. The mucosal barrier following abutment dis/reconnection. An experimental study in dogs. J Clin Periodontol. 1997 Aug;24(8):568-72. doi: 10.1111/j.1600-051x.1997.tb00230.x.
PubMed 9266344Tarnow DP, Cho SC, Wallace SS. The effect of inter-implant distance on the height of inter-implant bone crest. J Periodontol. 2000 Apr;71(4):546-9. doi: 10.1902/jop.2000.71.4.546.
PubMed 10807116Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006 Feb;26(1):9-17.
PubMed 16515092Canullo L, Bignozzi I, Cocchetto R, Cristalli MP, Iannello G. Immediate positioning of a definitive abutment versus repeated abutment replacements in post-extractive implants: 3-year follow-up of a randomised multicentre clinical trial. Eur J Oral Implantol. 2010 Winter;3(4):285-96.
PubMed 21180681Pieri F, Aldini NN, Marchetti C, Corinaldesi G. Influence of implant-abutment interface design on bone and soft tissue levels around immediately placed and restored single-tooth implants: a randomized controlled clinical trial. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):169-78.
PubMed 21365053Becker K, Mihatovic I, Golubovic V, Schwarz F. Impact of abutment material and dis-/re-connection on soft and hard tissue changes at implants with platform-switching. J Clin Periodontol. 2012 Aug;39(8):774-80. doi: 10.1111/j.1600-051X.2012.01911.x. Epub 2012 Jun 7.
PubMed 22676071Rodriguez X, Vela X, Mendez V, Segala M, Calvo-Guirado JL, Tarnow DP. The effect of abutment dis/reconnections on peri-implant bone resorption: a radiologic study of platform-switched and non-platform-switched implants placed in animals. Clin Oral Implants Res. 2013 Mar;24(3):305-11. doi: 10.1111/j.1600-0501.2011.02317.x. Epub 2011 Oct 3.
PubMed 22092773Iglhaut G, Becker K, Golubovic V, Schliephake H, Mihatovic I. The impact of dis-/reconnection of laser microgrooved and machined implant abutments on soft- and hard-tissue healing. Clin Oral Implants Res. 2013 Apr;24(4):391-7. doi: 10.1111/clr.12040. Epub 2012 Sep 26.
PubMed 23009248
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implant Abutment Dis-/Reconnection on Peri-Implant Marginal Bone Loss - Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT02617212
- Acronym / sponsor ID
- 1.310.562
- Conditions
- Alveolar Bone Loss
- Keywords
- dental implant, bone preservation, definitive abutment, one abutment one time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fortaleza UniversityUniversity, hospital or other
- Collaborators
- Universidade Federal do Ceara
- Study start
- 1 Nov 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 30 Nov 2015 (estimated)
- 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 purpose of this study is to investigate whether the immediate definitive abutment connection to dental implant is effective in preventing marginal bone loss when compared to the conventional treatment with late abutment/implant connection, which include three disconnections and reconnections.
Detailed description
The proposed study is a randomized clinical trial in which the participants will be allocated into one of the two arms according to the proposed intervention: experimental group, in which the abutments will be permanently connected immediately at the implant placement procedure; and control group (active comparator) with conventional treatment, where the abutments will be disconnected and reconnected three times.
Considering the inclusion and exclusion criteria related to oral and systemic health, a sample of participants will be selected among those partially edentulous patients who seek for dental implants treatment at the Fortaleza University School of Dentistry.
The sample size has been calculated based on the standard deviation of 0.17 mm, significance level of 5% and 80% statistical test power. To detect a clinically significant difference of 0.2 mm, each group should be composed of 11 participants. Therefore, considering a 10% margin for possible dropouts or missing data, the study will include 24 participants divided into two groups. Each participant will receive one or two implants according to his/her needs, so the study may include more than 24 implants.
A single surgeon will perform the implant surgical procedure in order to reduce variations inherent to clinical experience. After local anesthesia and incision on the top of the alveolar ridge, the bone will be exposed by the mucoperiosteal flap elevation. The mucosal thickness will be measured at implant sites, before the lingual/palatal flap elevation, with a periodontal probe.
The drilling sequence will be done according to manufacturer's recommendations, under saline solution irrigation, intermittent movements and speed up to 1200rpm.
The implants should develop a final insertion torque of 32Ncm or above to enable abutment connection torque, indicated at the experimental arm. The implant primary stability will be also measured by resonance frequency analysis (Osstell; Osstell AB, Gothenburg, Sweden). A minimum 65 ISQ will be required to a single-stage surgery. Thus, those implants that do not contemplate these requirements will be excluded from the study and will receive a conventional treatment with two-stage surgery if necessary.
Before finishing the surgical procedure, the volunteers will be randomly assigned to one of the two arms by opening sealed envelopes with a random sequence generated by Excel (Microsoft, Redmond, Washington, USA). Therefore, the surgeon will identify each volunteer's arm only after the end of drilling, insertion and stabilization of the implants.
Each implant allocated at the control arm (active comparator) will receive conventional treatment with three abutment disconnections and reconnections. At the experimental arm, each implant will receive the prosthetic abutment in a definitive way immediately at the surgical procedure, avoiding any abutment disconnection.
The surgeries of both arms will be finished with suture, drug prescription and postoperative recommendations. All implants will receive temporary crowns at three months and definitive prosthesis until six months after surgery.
Intraoral radiographs will be done with paralleling technique immediately after surgery (baseline) and at 3, 6, 12 and 24 months later. The radiographs will have its dimensions corrected at the ImageJ software (National Institutes of Health, Bethesda, Maryland, USA) having implant known dimensions as reference.
Each implant will have its radiographs evaluated by a previously calibrated examiner with a minimum of 0.8 intra-rater reliability for the intraclass correlation coefficient. The examiner will not know to which arm the X-rays belong.
Primary and secondary outcomes data will be submitted to normality test and compared using statistical tests for paired and unpaired samples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Definitive abutment | Experimental | Procedure: Implant surgery, Device: No abutment dis-/reconnections.Implant surgery. No abutment dis-/reconnections. |
| Conventional treatment | Active comparator | Procedure: Implant surgery, Device: Three abutment dis-/reconnections.Implant surgery. Three abutment dis-/reconnections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Partially edentulous patients requiring dental implant treatment for one or two dental units;
- Occlusal stability and regular occlusal plane;
- Enough space for implant and prosthesis;
- Good periodontal health
- Keratinized mucosa width > 4mm;
Key exclusion criteria (8 listed)
- Diabetes mellitus;
- Treatment with bisphosphonates;
- Head and neck irradiation;
- General contraindications to oral surgery;
- Pregnancy;
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 |
|---|---|---|
| Implant surgeryThe volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm. | Procedure or surgery | Conventional treatment, Definitive abutment |
| Three abutment dis-/reconnections.At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque. | Device | Conventional treatment |
| No abutment dis-/reconnections.Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery. | Device | Definitive abutment |
Primary outcome
Peri-implant marginal bone level change.
Time frame: 2, 6, 12 and 24 months after implant surgery.
To estimate the gingival margin stability and the long-term success of implant-supported restorations, the peri-implant marginal bone level will be assessed as primary outcome through intraoral radiographs, in a perspective of bone maintenance, bone loss or bone gain.
4 secondary outcomes
Implant stability change.
Time frame: 3 and 6 months after implant surgery.
Gingival level change.
Time frame: 6, 12 and 24 months after implant surgery.
Peri-implant probing depth change.
Time frame: 12 and 24 months after implant surgery.
Bleeding on probing change.
Time frame: 12 and 24 months after implant surgery.
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 13 May 2024.
- Background: PubMed 6809663Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.
- Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
- Background: PubMed 9266344Abrahamsson I, Berglundh T, Lindhe J. The mucosal barrier following abutment dis/reconnection. An experimental study in dogs. J Clin Periodontol. 1997 Aug;24(8):568-72. doi: 10.1111/j.1600-051x.1997.tb00230.x.
- Background: PubMed 10807116Tarnow DP, Cho SC, Wallace SS. The effect of inter-implant distance on the height of inter-implant bone crest. J Periodontol. 2000 Apr;71(4):546-9. doi: 10.1902/jop.2000.71.4.546.
- Background: PubMed 16515092Lazzara RJ, Porter SS. Platform switching: a new concept in implant dentistry for controlling postrestorative crestal bone levels. Int J Periodontics Restorative Dent. 2006 Feb;26(1):9-17.
- Background: PubMed 21180681Canullo L, Bignozzi I, Cocchetto R, Cristalli MP, Iannello G. Immediate positioning of a definitive abutment versus repeated abutment replacements in post-extractive implants: 3-year follow-up of a randomised multicentre clinical trial. Eur J Oral Implantol. 2010 Winter;3(4):285-96.
- Background: PubMed 21365053Pieri F, Aldini NN, Marchetti C, Corinaldesi G. Influence of implant-abutment interface design on bone and soft tissue levels around immediately placed and restored single-tooth implants: a randomized controlled clinical trial. Int J Oral Maxillofac Implants. 2011 Jan-Feb;26(1):169-78.
- Background: PubMed 22676071Becker K, Mihatovic I, Golubovic V, Schwarz F. Impact of abutment material and dis-/re-connection on soft and hard tissue changes at implants with platform-switching. J Clin Periodontol. 2012 Aug;39(8):774-80. doi: 10.1111/j.1600-051X.2012.01911.x. Epub 2012 Jun 7.
- Background: PubMed 22092773Rodriguez X, Vela X, Mendez V, Segala M, Calvo-Guirado JL, Tarnow DP. The effect of abutment dis/reconnections on peri-implant bone resorption: a radiologic study of platform-switched and non-platform-switched implants placed in animals. Clin Oral Implants Res. 2013 Mar;24(3):305-11. doi: 10.1111/j.1600-0501.2011.02317.x. Epub 2011 Oct 3.
- Background: PubMed 23009248Iglhaut G, Becker K, Golubovic V, Schliephake H, Mihatovic I. The impact of dis-/reconnection of laser microgrooved and machined implant abutments on soft- and hard-tissue healing. Clin Oral Implants Res. 2013 Apr;24(4):391-7. doi: 10.1111/clr.12040. Epub 2012 Sep 26.
- 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.
Rodrigo O. Rego, PhD study director
Universidade Federal do Ceara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant surgery, Three abutment dis-/reconnections. and No abutment dis-/reconnections. in people with Alveolar Bone Loss, run by Fortaleza University 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 6 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 13 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 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?
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?
Peri-implant marginal bone level change. (time frame: 2, 6, 12 and 24 months after implant surgery.). 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 NCT02617212, 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 13 May 2024.