Gingival RecessionPhase 4NCT02230787
Gingival Recession Coverage With and Without Emdogain
A Phase 4 study testing Recession coverage without Emdogain and Recession coverage with Emdogain in people with Gingival Recession and Emdogain, run by University of Bern at 1 site in Switzerland.
Trial summary
Enamel matrix proteins have been shown to play a crucial role during tooth development and its supporting tissues. This is used in periodontal surgery where regeneration of lost tissues around the teeth is intended. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gingival Recession, Emdogain
- What is being tested?
- Recession coverage without Emdogain and Recession coverage with Emdogain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2014to 14 Feb 2017
- Phase
- Phase 4
- 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
- Gingival recession Miller class I and II
- Written informed consent
Who cannot join
- Patients with a history of a chronic infectious or inflammatory diseases (i.e. rheumatoid arthritis, systemic lupus erythematodes, Crohn's disease, or HIV-, HCV-infection etc.
- Patients with any clinical signs of an acute infection
- Patients with renal failure (GFR < 30ml/min)
- Smoking > 5 cigarettes per day
- Patients < 18 years of age
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Periodontology, University of Bern
Bern, 3010
About this study
Official title: Effect of Emdogain on Wound Healing After Gingival Recession Coverage Using Connective Tissue Graft: A Pilot Study
Enamel matrix proteins have been shown to play a crucial role during tooth development and its supporting tissues. This is used in periodontal surgery where regeneration of lost tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains these matrix proteins and has been successfully used in regenerative periodontal surgery for more than 16 years.
The treatment of gum recession is a common requirement, more and more patients are seeking treatment at the investigators' clinic due to aesthetic concern, root sensitivity and difficulties in performing adequate oral hygiene. The standard treatment comprises the transplantation of a piece of connective tissue from the palate to the denuded root surface. In many cases Emdogain is additionally applied to enhance healing. So far the effect of Emdogain on the early wound healing process after surgical root coverage has not been investigated.
The purpose of the investigators' study is to compare early wound healing parameters between treatment with and without Emdogain. For this study 40 patients undergoing root coverage surgery at the investigators' department will be included. Early wound healing features between the two groups will be described and compared. Furthermore, inflammatory markers typical for early healing will be evaluated together with patients'subjective postoperative comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators' hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative complication rates.
Read the detailed description
Background
Effect of Emdogain on wound healing after gingival recession coverage using connective tissue graft: a pilot study Emdogain Treatment Emdogain (Institute Straumann, Basel Switzerland) is an enamel matrix protein derivative with the vehicle propylene glycol alginate. Emdogain has been used for more than 16 years for regenerative periodontal treatment of intrabony, class II furcation and recession defects. Animal and human histological studies have provided evidence for periodontal regeneration (e.g. formation of root cementum, periodontal ligament and alveolar bone) following the application of Emdogain in conjunction with periodontal surgery. The use of Emdogain has been shown to significantly improve the clinical outcomes evidenced by probing depth reduction, and clinical attachment gain and is considered today as a routine procedure.
Background Therapy of buccal gingival recession is a common indication for treatment in order to improve plaque control thus preventing gingivitis and root caries but also to improve aesthetics and root sensitivity. The ultimate goal of a root coverage procedure is the complete coverage of the root surface and, in the same time, to obtain a similar appearance of the regenerated soft tissues to the surrounding intact tissues. The use of palatal connective tissue graft in conjunction with a coronally advanced flap (CAF) is a well established clinical procedure for the treatment of gingival recessions. Its use has been shown to result in predictable root coverage, higher increase in keratinized tissue and more stable long-term outcomes compared to the use of CAF and is considered today state of the art. Furthermore, recent data also appear to indicate that the combination of Emdogain and CTG may additionally improve the clinical outcomes. Therefore, the standard surgical procedure for the treatment of gingival recessions at the Department of Periodontology includes the use of connective tissue graft either with or without the use of Emdogain.
Interestingly, despite the fact that Emdogain is commonly used, no information on its effects upon early wound healing is available.
Hence, the aim of this study is to evaluate the effect of Emdogain on early wound healing, as assessed by means of clinical parameters and inflammatory markers following recession coverage surgery.
Study population and methodology Patient groups compared: in the treatment group, patients undergoing a recession coverage surgery will be treated with Emdogain whereas in the control group, patients will not receive Emdogain. A total of 40 patients, 20 in each group will be included.
Preoperative inflammatory markers will be assessed at the preoperative examination and two days after surgery by dipping paper points into the crevicular fluid. Furthermore the investigators will assess whether remnants of Emdogain are still traceable two days after surgery. Wound healing after root coverage procedure is assessed using the "early wound healing index (EHI)" defined by Wachtel et al. According to Wachtel et al., wound healing is quantified and graded into 5 stages.
Additionally, the post-operative healing process will be judged by a patient questionnaire. Finally root coverage is measured as the distance from the CEJ (Cemento Enamel Junction) to the Margo Gingivae in mm.
Objective
- To investigate the benefit of intraoperative use of Emdogain on early wound healing during the first two weeks after gingival recession coverage. Early wound healing parameters will be assessed at both the site of explantation of the tissue graft as well as at the site of implantation.
- To investigate the effect of Emdogain on inflammatory markers in crevicular fluid and whether Emdogain is traceable after two days after application.
- To investigate its influence on post-operative pain and interference with daily activities during the first two weeks (patient's questionnaire).
- The post-operative result will also be assessed after 6 months.
Methods
The present prospective study will include a total of 40 patients, 20 patients in each of the 2 groups (Emdogain group and control group). All procedures will be elective procedures. After oral and written informed consent, the study will comprise the collection of crevicular fluid sampling and clinical data as well as the filling of a patient questionnaire. The study will be conducted as randomized prospective study. In the treatment group the procedure will be performed with Emdogain, in the control group, root coverage will be performed without, respectively. All procedures will be performed by one experienced operator. Patients will all be treated with the standard surgical procedure of the University of Bern. In the patient group with Emdogain, tissue graft and explantation site will be covered with Emdogain, in the patient group without Emdogain, no Emdogain will be used. After inclusion of the patients, the study duration will last 6 months for each patient.
- Conditions
- Gingival Recession, Emdogain
- Being tested
- Recession coverage without Emdogain, Recession coverage with Emdogain
- Keywords
- Pilot study, randomized clinical trial, periodontal disease, gingival recession, Emdogain, connective tissue, wound healing, inflammation
- Medical subject headings
- Gingival Recession, Periodontal Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recession coverage without EmdogainDevice
In the control group subjects the recession coverage surgery will be performed without Emdogain.
Recession coverage with EmdogainDevice
In the test group subjects the recession coverage surgery will be performed with Emdogain.
| Study group | Role | What they receive |
|---|---|---|
| Recession coverage without Emdogain | Active comparator | Not described Receives: Device: Recession coverage without Emdogain |
| Recession coverage with Emdogain | Experimental | Not described Receives: Device: Recession coverage with Emdogain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in wound healing
Progress in wound healing assessed by the "early wound healing index (EHI)" previously defined by Wachtel et al.
Measured: 2, 7 and 14 days after surgery
Secondary outcomes (3)
Levels of post-procedural inflammatory markers
Including IL- 8, IL-10, IL-1beta, MMP-8 and TGF beta-1, traceability of Emdogain in the operation field
Measured: 2 and 7 days after surgery
Improvement of patients' post-operative comfort
Assessed by patient questionnaire
Measured: 2 days to 2 weeks after surgery
Root coverage
Measured in mm
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startAug 2014
- Primary completion22 Apr 2016
- Study completion14 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anton Sculean, Prof. Dr. med. dent., Principal investigator, Department of Periodontology, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230787
- Sponsor's protocol ID
- 186/13
- Status last verified
- Apr 2017
- First submitted
- 12 Aug 2014
- Last updated
- 20 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Grandin HM, Gemperli AC, Dard M. Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. Tissue Eng Part B Rev. 2012 Jun;18(3):181-202. doi: 10.1089/ten.TEB.2011.0365. Epub 2011 Dec 28.
PubMed 22070552Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique: a 2-year report. J Periodontol. 2005 Nov;76(11):1871-80. doi: 10.1902/jop.2005.76.11.1871.
PubMed 16274306Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.
PubMed 12795787Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
PubMed 18724847Henriques PS, Pelegrine AA, Nogueira AA, Borghi MM. Application of subepithelial connective tissue graft with or without enamel matrix derivative for root coverage: a split-mouth randomized study. J Oral Sci. 2010 Sep;52(3):463-71. doi: 10.2334/josnusd.52.463.
PubMed 20881341Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T. A comparative study of coronally advanced flaps with and without the addition of enamel matrix derivative in the treatment of marginal tissue recession. J Periodontol. 2004 Jul;75(7):949-56. doi: 10.1902/jop.2004.75.7.949.
PubMed 15341352Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
PubMed 23627374Rasperini G, Roccuzzo M, Francetti L, Acunzo R, Consonni D, Silvestri M. Subepithelial connective tissue graft for treatment of gingival recessions with and without enamel matrix derivative: a multicenter, randomized controlled clinical trial. Int J Periodontics Restorative Dent. 2011 Apr;31(2):133-9.
PubMed 21491012
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Emdogain on Wound Healing After Gingival Recession Coverage Using Connective Tissue Graft: A Pilot Study
- ClinicalTrials.gov ID
- NCT02230787
- Acronym / sponsor ID
- 186/13
- Conditions
- Gingival Recession, Emdogain
- Keywords
- Pilot study, randomized clinical trial, periodontal disease, gingival recession, Emdogain, connective tissue, wound healing, inflammation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Aug 2014 (actual)
- Primary completion
- 22 Apr 2016 (actual)
- Study completion
- 14 Feb 2017 (actual)
- First posted
- 3 Sep 2014 (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.
Enamel matrix proteins have been shown to play a crucial role during tooth development and its supporting tissues. This is used in periodontal surgery where regeneration of lost tissues around the teeth is intended. Emdogain, a product of Straumann Institute contains these matrix proteins and has been successfully used in regenerative periodontal surgery for more than 16 years.
The treatment of gum recession is a common requirement, more and more patients are seeking treatment at the investigators' clinic due to aesthetic concern, root sensitivity and difficulties in performing adequate oral hygiene. The standard treatment comprises the transplantation of a piece of connective tissue from the palate to the denuded root surface. In many cases Emdogain is additionally applied to enhance healing. So far the effect of Emdogain on the early wound healing process after surgical root coverage has not been investigated.
The purpose of the investigators' study is to compare early wound healing parameters between treatment with and without Emdogain. For this study 40 patients undergoing root coverage surgery at the investigators' department will be included. Early wound healing features between the two groups will be described and compared. Furthermore, inflammatory markers typical for early healing will be evaluated together with patients'subjective postoperative comfort. Finally, outcomes 6 months after the treatment will be assessed. The investigators' hypothesis is that Emdogain treatment enhances wound healing and decreases post-operative complication rates.
Detailed description
Background
Effect of Emdogain on wound healing after gingival recession coverage using connective tissue graft: a pilot study Emdogain Treatment Emdogain (Institute Straumann, Basel Switzerland) is an enamel matrix protein derivative with the vehicle propylene glycol alginate. Emdogain has been used for more than 16 years for regenerative periodontal treatment of intrabony, class II furcation and recession defects. Animal and human histological studies have provided evidence for periodontal regeneration (e.g. formation of root cementum, periodontal ligament and alveolar bone) following the application of Emdogain in conjunction with periodontal surgery. The use of Emdogain has been shown to significantly improve the clinical outcomes evidenced by probing depth reduction, and clinical attachment gain and is considered today as a routine procedure.
Background Therapy of buccal gingival recession is a common indication for treatment in order to improve plaque control thus preventing gingivitis and root caries but also to improve aesthetics and root sensitivity. The ultimate goal of a root coverage procedure is the complete coverage of the root surface and, in the same time, to obtain a similar appearance of the regenerated soft tissues to the surrounding intact tissues. The use of palatal connective tissue graft in conjunction with a coronally advanced flap (CAF) is a well established clinical procedure for the treatment of gingival recessions. Its use has been shown to result in predictable root coverage, higher increase in keratinized tissue and more stable long-term outcomes compared to the use of CAF and is considered today state of the art. Furthermore, recent data also appear to indicate that the combination of Emdogain and CTG may additionally improve the clinical outcomes. Therefore, the standard surgical procedure for the treatment of gingival recessions at the Department of Periodontology includes the use of connective tissue graft either with or without the use of Emdogain.
Interestingly, despite the fact that Emdogain is commonly used, no information on its effects upon early wound healing is available.
Hence, the aim of this study is to evaluate the effect of Emdogain on early wound healing, as assessed by means of clinical parameters and inflammatory markers following recession coverage surgery.
Study population and methodology Patient groups compared: in the treatment group, patients undergoing a recession coverage surgery will be treated with Emdogain whereas in the control group, patients will not receive Emdogain. A total of 40 patients, 20 in each group will be included.
Preoperative inflammatory markers will be assessed at the preoperative examination and two days after surgery by dipping paper points into the crevicular fluid. Furthermore the investigators will assess whether remnants of Emdogain are still traceable two days after surgery. Wound healing after root coverage procedure is assessed using the "early wound healing index (EHI)" defined by Wachtel et al. According to Wachtel et al., wound healing is quantified and graded into 5 stages.
Additionally, the post-operative healing process will be judged by a patient questionnaire. Finally root coverage is measured as the distance from the CEJ (Cemento Enamel Junction) to the Margo Gingivae in mm.
Objective
- To investigate the benefit of intraoperative use of Emdogain on early wound healing during the first two weeks after gingival recession coverage. Early wound healing parameters will be assessed at both the site of explantation of the tissue graft as well as at the site of implantation.
- To investigate the effect of Emdogain on inflammatory markers in crevicular fluid and whether Emdogain is traceable after two days after application.
- To investigate its influence on post-operative pain and interference with daily activities during the first two weeks (patient's questionnaire).
- The post-operative result will also be assessed after 6 months.
Methods
The present prospective study will include a total of 40 patients, 20 patients in each of the 2 groups (Emdogain group and control group). All procedures will be elective procedures. After oral and written informed consent, the study will comprise the collection of crevicular fluid sampling and clinical data as well as the filling of a patient questionnaire. The study will be conducted as randomized prospective study. In the treatment group the procedure will be performed with Emdogain, in the control group, root coverage will be performed without, respectively. All procedures will be performed by one experienced operator. Patients will all be treated with the standard surgical procedure of the University of Bern. In the patient group with Emdogain, tissue graft and explantation site will be covered with Emdogain, in the patient group without Emdogain, no Emdogain will be used. After inclusion of the patients, the study duration will last 6 months for each patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recession coverage without Emdogain | Active comparator | Device: Recession coverage without Emdogain |
| Recession coverage with Emdogain | Experimental | Device: Recession coverage with Emdogain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gingival recession Miller class I and II
- Written informed consent
Key exclusion criteria (5 listed)
- Patients with a history of a chronic infectious or inflammatory diseases (i.e. rheumatoid arthritis, systemic lupus erythematodes, Crohn's disease, or HIV-, HCV-infection etc.
- Patients with any clinical signs of an acute infection
- Patients with renal failure (GFR < 30ml/min)
- Smoking > 5 cigarettes per day
- Patients < 18 years of age
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 |
|---|---|---|
| Recession coverage without EmdogainIn the control group subjects the recession coverage surgery will be performed without Emdogain. | Device | Recession coverage without Emdogain |
| Recession coverage with EmdogainIn the test group subjects the recession coverage surgery will be performed with Emdogain. | Device | Recession coverage with Emdogain |
Primary outcome
Change from baseline in wound healing
Time frame: 2, 7 and 14 days after surgery
Progress in wound healing assessed by the "early wound healing index (EHI)" previously defined by Wachtel et al.
3 secondary outcomes
Levels of post-procedural inflammatory markers
Time frame: 2 and 7 days after surgery
Improvement of patients' post-operative comfort
Time frame: 2 days to 2 weeks after surgery
Root coverage
Time frame: 6 months after 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 20 Apr 2017.
- Background: PubMed 22070552Grandin HM, Gemperli AC, Dard M. Enamel matrix derivative: a review of cellular effects in vitro and a model of molecular arrangement and functioning. Tissue Eng Part B Rev. 2012 Jun;18(3):181-202. doi: 10.1089/ten.TEB.2011.0365. Epub 2011 Dec 28.
- Background: PubMed 16274306Spahr A, Haegewald S, Tsoulfidou F, Rompola E, Heijl L, Bernimoulin JP, Ring C, Sander S, Haller B. Coverage of Miller class I and II recession defects using enamel matrix proteins versus coronally advanced flap technique: a 2-year report. J Periodontol. 2005 Nov;76(11):1871-80. doi: 10.1902/jop.2005.76.11.1871.
- Background: PubMed 12795787Wachtel H, Schenk G, Bohm S, Weng D, Zuhr O, Hurzeler MB. Microsurgical access flap and enamel matrix derivative for the treatment of periodontal intrabony defects: a controlled clinical study. J Clin Periodontol. 2003 Jun;30(6):496-504. doi: 10.1034/j.1600-051x.2003.00013.x.
- Background: PubMed 18724847Cairo F, Pagliaro U, Nieri M. Treatment of gingival recession with coronally advanced flap procedures: a systematic review. J Clin Periodontol. 2008 Sep;35(8 Suppl):136-62. doi: 10.1111/j.1600-051X.2008.01267.x.
- Results publication: PubMed 20881341Henriques PS, Pelegrine AA, Nogueira AA, Borghi MM. Application of subepithelial connective tissue graft with or without enamel matrix derivative for root coverage: a split-mouth randomized study. J Oral Sci. 2010 Sep;52(3):463-71. doi: 10.2334/josnusd.52.463.
- Results publication: PubMed 15341352Cueva MA, Boltchi FE, Hallmon WW, Nunn ME, Rivera-Hidalgo F, Rees T. A comparative study of coronally advanced flaps with and without the addition of enamel matrix derivative in the treatment of marginal tissue recession. J Periodontol. 2004 Jul;75(7):949-56. doi: 10.1902/jop.2004.75.7.949.
- Results publication: PubMed 23627374Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
- Results publication: PubMed 21491012Rasperini G, Roccuzzo M, Francetti L, Acunzo R, Consonni D, Silvestri M. Subepithelial connective tissue graft for treatment of gingival recessions with and without enamel matrix derivative: a multicenter, randomized controlled clinical trial. Int J Periodontics Restorative Dent. 2011 Apr;31(2):133-9.
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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.
Anton Sculean, Prof. Dr. med. dent. principal investigator
Department of Periodontology, University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recession coverage without Emdogain and Recession coverage with Emdogain in people with Gingival Recession and Emdogain, run by University of Bern at 1 site in Switzerland.
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 5 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 20 Apr 2017. 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 Switzerland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in wound healing (time frame: 2, 7 and 14 days after 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 NCT02230787, which also lists 8 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 20 Apr 2017.