Peri-ImplantitisPhase 4NCT01857804
Surgical Treatment of Peri-implantitis
A Phase 4 study testing Amoxicillin, Chlorhexidine gluconate and Saline in people with Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
Trial summary
The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics. Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Amoxicillin, Chlorhexidine gluconate and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2013to Nov 2014
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- peri-implant probing pocket depth > 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,
- marginal bone loss > 3mm as detected in radiographs.
Who cannot join
- implant mobility,
- peri-implantitis associated bone defects not suitable for pocket elimination therapy,
- systemic diseases that could influence the outcome of the therapy,
- penicillin allergy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Periodontology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg
Gothenburg, 40530
About this study
Official title: Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study
The objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics.
Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.
Read the detailed description
The study is designed as a randomized controlled clinical trial. 100 patients with severe peri-implantitis at one or more implants needing surgical treatment will be recruited. All individuals have to show unremarkable general health and not been using any antibiotics during the 6 months preceding the current examination.
The patients will be randomly assigned to the following :
- test group (T) : surgical treatment with systemic antibiotics,
- control group (C) : surgical treatment without systemic antibiotics. A stratification protocol will be applied regarding distribution of smokers. Two subgroups will be formed among test and control subjects.
- saline group (T1 and C1) : the exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment, and,
- antiseptics group (T2 and C2) : the exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine 0,2%) during the surgical treatment.
A stratification protocol will be applied regarding distribution of smokers.
Following the baseline examination, patients will randomly be assigned to the various treatment group. Samples from the subgingival microbiota will be obtained before surgical therapy.
All patients will be enrolled in a hygiene program including professional supragingival implant/tooth cleaning using rubber cups and polishing paste and oral hygiene instructions.
The following clinical parameters will be measured at baseline using a periodontal probe: plaque index, Bleeding on Probing, probing depth measured from the mucosal margin to the bottom of the probable pocket and mucosal recession measured from a fixed landmark on the implant to the mucosal margin.
The measurements will be made at 4 aspects of each implant. In the test group (T) a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient) Intra-oral radiographs will be taken at 2 weeks and 1 year after surgical therapy.
The professional implant/tooth cleaning and reinforcement of oral hygiene will be performed at 2 weeks, 1, 2, 3, 6, and 12 months after treatment.
Examination of clinical outcome variables will be performed at 3, 6 and 12 months after surgical therapy. Microbiological samples will be obtained at the same time points. Radiographs are taken 2 weeks post surgical and at the one year examination.
Primary outcomes variables include: (i) clinical signs of resolution of peri-implantitis (pocket closure and absence of BoP), (ii) recurrence of the disease (BoP and increase in PPD) and (iii) further loss in marginal bone support, and (iiii) microbiological findings.
- Conditions
- Peri-Implantitis
- Being tested
- Amoxicillin, Chlorhexidine gluconate, Saline
- Keywords
- peri-implantitis, surgical therapy, systemic antibiotics, local antiseptics
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmoxicillinDrug
Also called systemic antibiotics
In the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient)
Chlorhexidine gluconateDrug
Also called chlorhexidine gluconate 0,2%
The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment
SalineDrug
The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment
| Study group | Role | What they receive |
|---|---|---|
| antibiotics and local antiseptics | Experimental | systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2% Receives: Drug: Amoxicillin; Drug: Chlorhexidine gluconate |
| antibiotics without local antiseptics | Experimental | systemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline Receives: Drug: Amoxicillin |
| local antiseptics no antibiotics | Experimental | no systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2% Receives: Drug: Chlorhexidine gluconate |
| no antibiotics and no local antiseptics | Placebo comparator | no systemic antibiotics + implant surface decontamination with saline Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
pocket closure
absence of probing pocket depth > 5 mm and no bleeding on probing
Measured: 6 months, 1 year
bone level stability
no further peri-implant marginal bone loss in the observation period.
Measured: 1 year
Secondary outcomes (1)
Quantitative and qualitative change in levels of the peri-implant microflora
Quantitative and qualitative change in levels of the peri-implant microflora
Measured: 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor
- Investigators
- Tord Berglundh, Professor, Study chair, Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01857804
- Sponsor's protocol ID
- olivier1
- Status last verified
- Nov 2014
- First submitted
- 16 May 2013
- Last updated
- 13 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
PubMed 21092053Ericsson I, Persson LG, Berglundh T, Edlund T, Lindhe J. The effect of antimicrobial therapy on periimplantitis lesions. An experimental study in the dog. Clin Oral Implants Res. 1996 Dec;7(4):320-8. doi: 10.1034/j.1600-0501.1996.070404.x.
PubMed 9151598Gualini F, Berglundh T. Immunohistochemical characteristics of inflammatory lesions at implants. J Clin Periodontol. 2003 Jan;30(1):14-8. doi: 10.1034/j.1600-051x.2003.300103.x.
PubMed 12702106Leonhardt A, Dahlen G, Renvert S. Five-year clinical, microbiological, and radiological outcome following treatment of peri-implantitis in man. J Periodontol. 2003 Oct;74(10):1415-22. doi: 10.1902/jop.2003.74.10.1415.
PubMed 14653386Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.
PubMed 11488856Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.
PubMed 1298430Persson LG, Ericsson I, Berglundh T, Lindhe J. Guided bone regeneration in the treatment of periimplantitis. Clin Oral Implants Res. 1996 Dec;7(4):366-72. doi: 10.1034/j.1600-0501.1996.070410.x.
PubMed 9151604Persson LG, Ericsson I, Berglundh T, Lindhe J. Osseintegration following treatment of peri-implantitis and replacement of implant components. An experimental study in the dog. J Clin Periodontol. 2001 Mar;28(3):258-63. doi: 10.1034/j.1600-051x.2001.028003258.x.
PubMed 11284540Persson LG, Mouhyi J, Berglundh T, Sennerby L, Lindhe J. Carbon dioxide laser and hydrogen peroxide conditioning in the treatment of periimplantitis: an experimental study in the dog. Clin Implant Dent Relat Res. 2004;6(4):230-8. doi: 10.1111/j.1708-8208.2004.tb00039.x.
PubMed 15841583Wetzel AC, Vlassis J, Caffesse RG, Hammerle CH, Lang NP. Attempts to obtain re-osseointegration following experimental peri-implantitis in dogs. Clin Oral Implants Res. 1999 Apr;10(2):111-9. doi: 10.1034/j.1600-0501.1999.100205.x.
PubMed 10219130Adly MS, Adly AS, Rasheed AM, Adly AS. CAN COMBINING LOW LEVEL LASER THERAPY WITH COMPUTER GUIDED FLAPLESS PIEZOSURGICAL OSTEOTOMY ACHIEVE A PAINLESS IMPLANT SURGERY? FINDINGS OF SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2022 Sep;22(3):101730. doi: 10.1016/j.jebdp.2022.101730. Epub 2022 Apr 18.
PubMed 36162887Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1.
PubMed 26309133Carcuac O, Derks J, Charalampakis G, Abrahamsson I, Wennstrom J, Berglundh T. Adjunctive Systemic and Local Antimicrobial Therapy in the Surgical Treatment of Peri-implantitis: A Randomized Controlled Clinical Trial. J Dent Res. 2016 Jan;95(1):50-7. doi: 10.1177/0022034515601961. Epub 2015 Aug 18.
PubMed 26285807
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Peri-implantitis With and Without Adjunctive Use of Antibiotics : a Controlled and Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT01857804
- Acronym / sponsor ID
- olivier1
- Conditions
- Peri-Implantitis
- Keywords
- peri-implantitis, surgical therapy, systemic antibiotics, local antiseptics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 20 May 2013 (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 objective of this randomized controlled clinical trial is to evaluate the outcome of treatment of peri-implantitis with or without systemic antibiotics.
Specific aims are to analyze (i) the effect of systemic antibiotics and local antiseptics on the healing process, and (ii) the risk for recurrence of disease following surgical treatment of peri-implantitis.
Detailed description
The study is designed as a randomized controlled clinical trial. 100 patients with severe peri-implantitis at one or more implants needing surgical treatment will be recruited. All individuals have to show unremarkable general health and not been using any antibiotics during the 6 months preceding the current examination.
The patients will be randomly assigned to the following :
- test group (T) : surgical treatment with systemic antibiotics,
- control group (C) : surgical treatment without systemic antibiotics. A stratification protocol will be applied regarding distribution of smokers. Two subgroups will be formed among test and control subjects.
- saline group (T1 and C1) : the exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment, and,
- antiseptics group (T2 and C2) : the exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine 0,2%) during the surgical treatment.
A stratification protocol will be applied regarding distribution of smokers.
Following the baseline examination, patients will randomly be assigned to the various treatment group. Samples from the subgingival microbiota will be obtained before surgical therapy.
All patients will be enrolled in a hygiene program including professional supragingival implant/tooth cleaning using rubber cups and polishing paste and oral hygiene instructions.
The following clinical parameters will be measured at baseline using a periodontal probe: plaque index, Bleeding on Probing, probing depth measured from the mucosal margin to the bottom of the probable pocket and mucosal recession measured from a fixed landmark on the implant to the mucosal margin.
The measurements will be made at 4 aspects of each implant. In the test group (T) a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient) Intra-oral radiographs will be taken at 2 weeks and 1 year after surgical therapy.
The professional implant/tooth cleaning and reinforcement of oral hygiene will be performed at 2 weeks, 1, 2, 3, 6, and 12 months after treatment.
Examination of clinical outcome variables will be performed at 3, 6 and 12 months after surgical therapy. Microbiological samples will be obtained at the same time points. Radiographs are taken 2 weeks post surgical and at the one year examination.
Primary outcomes variables include: (i) clinical signs of resolution of peri-implantitis (pocket closure and absence of BoP), (ii) recurrence of the disease (BoP and increase in PPD) and (iii) further loss in marginal bone support, and (iiii) microbiological findings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| antibiotics and local antiseptics | Experimental | Drug: Amoxicillin, Drug: Chlorhexidine gluconatesystemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with chlorhexidine gluconate 0,2% |
| antibiotics without local antiseptics | Experimental | Drug: Amoxicillinsystemic antibiotics (2 x 750mg amoxicillin/day) + implant surface decontamination with saline |
| local antiseptics no antibiotics | Experimental | Drug: Chlorhexidine gluconateno systemic antibiotics + implant surface decontamination with chlorhexidine gluconate 0,2% |
| no antibiotics and no local antiseptics | Placebo comparator | Drug: Salineno systemic antibiotics + implant surface decontamination with saline |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- peri-implant probing pocket depth > 7 mm on at least one aspect of the implant, together with BOP and/or suppuration,
- marginal bone loss > 3mm as detected in radiographs.
Key exclusion criteria (4 listed)
- implant mobility,
- peri-implantitis associated bone defects not suitable for pocket elimination therapy,
- systemic diseases that could influence the outcome of the therapy,
- penicillin allergy.
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 |
|---|---|---|
| AmoxicillinAlso: systemic antibioticsIn the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient) | Drug | antibiotics and local antiseptics, antibiotics without local antiseptics |
| Chlorhexidine gluconateAlso: chlorhexidine gluconate 0,2%The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment | Drug | antibiotics and local antiseptics, local antiseptics no antibiotics |
| SalineThe exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment | Drug | no antibiotics and no local antiseptics |
Primary outcome
pocket closure
Time frame: 6 months, 1 year
absence of probing pocket depth > 5 mm and no bleeding on probing
bone level stability
Time frame: 1 year
no further peri-implant marginal bone loss in the observation period.
1 secondary outcome
Quantitative and qualitative change in levels of the peri-implant microflora
Time frame: 3 months, 6 months, 1 year
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 Nov 2014.
- Background: PubMed 21092053Albouy JP, Abrahamsson I, Persson LG, Berglundh T. Implant surface characteristics influence the outcome of treatment of peri-implantitis: an experimental study in dogs. J Clin Periodontol. 2011 Jan;38(1):58-64. doi: 10.1111/j.1600-051X.2010.01631.x. Epub 2010 Nov 24.
- Background: PubMed 9151598Ericsson I, Persson LG, Berglundh T, Edlund T, Lindhe J. The effect of antimicrobial therapy on periimplantitis lesions. An experimental study in the dog. Clin Oral Implants Res. 1996 Dec;7(4):320-8. doi: 10.1034/j.1600-0501.1996.070404.x.
- Background: PubMed 12702106Gualini F, Berglundh T. Immunohistochemical characteristics of inflammatory lesions at implants. J Clin Periodontol. 2003 Jan;30(1):14-8. doi: 10.1034/j.1600-051x.2003.300103.x.
- Background: PubMed 14653386Leonhardt A, Dahlen G, Renvert S. Five-year clinical, microbiological, and radiological outcome following treatment of peri-implantitis in man. J Periodontol. 2003 Oct;74(10):1415-22. doi: 10.1902/jop.2003.74.10.1415.
- Background: PubMed 11488856Mombelli A, Feloutzis A, Bragger U, Lang NP. Treatment of peri-implantitis by local delivery of tetracycline. Clinical, microbiological and radiological results. Clin Oral Implants Res. 2001 Aug;12(4):287-94. doi: 10.1034/j.1600-0501.2001.012004287.x. English, French, German.
- Background: PubMed 1298430Mombelli A, Lang NP. Antimicrobial treatment of peri-implant infections. Clin Oral Implants Res. 1992 Dec;3(4):162-8. doi: 10.1034/j.1600-0501.1992.030402.x.
- Background: PubMed 9151604Persson LG, Ericsson I, Berglundh T, Lindhe J. Guided bone regeneration in the treatment of periimplantitis. Clin Oral Implants Res. 1996 Dec;7(4):366-72. doi: 10.1034/j.1600-0501.1996.070410.x.
- Background: PubMed 11284540Persson LG, Ericsson I, Berglundh T, Lindhe J. Osseintegration following treatment of peri-implantitis and replacement of implant components. An experimental study in the dog. J Clin Periodontol. 2001 Mar;28(3):258-63. doi: 10.1034/j.1600-051x.2001.028003258.x.
- Background: PubMed 15841583Persson LG, Mouhyi J, Berglundh T, Sennerby L, Lindhe J. Carbon dioxide laser and hydrogen peroxide conditioning in the treatment of periimplantitis: an experimental study in the dog. Clin Implant Dent Relat Res. 2004;6(4):230-8. doi: 10.1111/j.1708-8208.2004.tb00039.x.
- Background: PubMed 10219130Wetzel AC, Vlassis J, Caffesse RG, Hammerle CH, Lang NP. Attempts to obtain re-osseointegration following experimental peri-implantitis in dogs. Clin Oral Implants Res. 1999 Apr;10(2):111-9. doi: 10.1034/j.1600-0501.1999.100205.x.
- Derived from this study: PubMed 36162887Adly MS, Adly AS, Rasheed AM, Adly AS. CAN COMBINING LOW LEVEL LASER THERAPY WITH COMPUTER GUIDED FLAPLESS PIEZOSURGICAL OSTEOTOMY ACHIEVE A PAINLESS IMPLANT SURGERY? FINDINGS OF SPLIT MOUTH RANDOMIZED CONTROLLED TRIAL. J Evid Based Dent Pract. 2022 Sep;22(3):101730. doi: 10.1016/j.jebdp.2022.101730. Epub 2022 Apr 18.
- Derived from this study: PubMed 26309133Graziani F, Cei S, Orlandi M, Gennai S, Gabriele M, Filice N, Nisi M, D'Aiuto F. Acute-phase response following full-mouth versus quadrant non-surgical periodontal treatment: A randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):843-852. doi: 10.1111/jcpe.12451. Epub 2015 Oct 1.
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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.
Tord Berglundh, Professor study chair
Department of Periodontology, Institute of Odontology, The sahlgrenska academy, University of Gothenburg
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 Amoxicillin, Chlorhexidine gluconate and Saline in people with Peri-Implantitis, run by Göteborg University at 1 site in Sweden.
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: finished, as of the sponsor's last update on 13 Nov 2014. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
pocket closure (time frame: 6 months, 1 year). The study lists 2 primary outcomes in all. 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 NCT01857804, which also lists 13 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 Nov 2014.