Poor Aesthetics of Existing RestorationPES/WESNCT02061930
Evaluation of the Aesthetic Outcomes of the Single Crowns Supported by Tissue Level Implants
An observational study of Poor Aesthetics of Existing Restoration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
The aim of this study is to review the long-term soft tissue stability and the long-term esthetic results of single crowns supported by tissue level implants placed in non-augmented healed sites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Poor Aesthetics of Existing Restoration
- What is being tested?
- single crowns supported by implants
- Type of treatment
- Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Feb 2014to Jun 2014
- Phase
- Observational
- 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
Study population: Have at least one implant-supported single crown in the anterior maxilla region (13-23) with Straumann (Institute Straumann AG, Waldenburg, Switzerland) tissue level implants placed between December 2005 and October 2008.
Who may be able to join
- Have had the tooth extraction at least 3 months before implant surgery.
- Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery.
- Did not receive restorative treatment of the adjacent teeth.
- Underwent conventional healing and loading protocol after implant surgery.
- Have both neighboring teeth and corresponding teeth in the mandible.
- ----For additional, the patients should have
- Photographs of the anterior teeth, the photos should have been taken at right after crown placement and at the 6-10 months recall visit.
- Radiographs of the implant-supported single crowns, the radiographs should have been taken at right after crown placement.
Who cannot join
- Patients who don't fulfill the inclusion criteria
- Patients who refused to join the study
Trial locations and contacts
1 site in 1 country.
China1 site
Dept. Oral & Maxillofacial Implantology ,Shanghai 9th People's Hospital
Shanghai, Shanghai Municipality, 200011
HongChang Lai, DDS, 86-021-23271699-5299, lhc9@hotmail.com
Hongchang Lai, DDS
About this study
Official title: Evaluation of the Soft Tissue Stability Around Single Crowns Supported by Tissue Level Implants Placed in Non-augmented Healed Sites in the Anterior Maxilla: a Retrospective Study
The aim of this study is to review the long-term soft tissue stability and the long-term esthetic results of single crowns supported by tissue level implants placed in non-augmented healed sites.
The hypothesis of the present study is that tissue level implants can achieve ideal esthetic outcomes in non-augmented healed sites.
Read the detailed description
Both successful implant-supported restorations and the peri-implant soft and hard tissues are vital determinants which may affect the short- and long-term aesthetic outcomes.
For this reason, the pink aesthetic score (PES) was introduced for the evaluation of peri-implant soft tissues by Fürhauser in 2005 and modified by Belser as PES/WES in 2009.
So far, a series of clinical studies have confirmed the suitability of PES/WES and PES index for the objective outcome assessment of the aesthetic dimension of anterior single-tooth implants.
However, to our knowledge, studies with long term data of the aesthetic outcome evaluation in non-augmented healed sites of the anterior maxilla are still rare, for most of the papers published recently mainly focused on immediate implant placement after tooth extraction with only 1-5 years following up.
In our previous study, we have evaluated the alterations of soft tissue around implant-supported single crowns in the anterior maxilla with original standard PES at the time of crown placement and 6 months post-loading .We have found that the aesthetic outcome of soft tissue around the single-tooth implant had improved significantly at follow-up compared with baseline according to PES assessment. However, the follow up time of the previous study was short (6-8 months), long time follow up is necessary to confirm the previous hypothesis and observations.
- Conditions
- Poor Aesthetics of Existing Restoration
- Being tested
- single crowns supported by implants
- Keywords
- single tooth, dental implant, aesthetics outcome, long term, soft tissue recession, pink esthetic score, white esthetic score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single crowns supported by implantsProcedure or surgery
Also called Straumann dental implants SLA sp
The implant placement procedures were planned based on clinical and radiographic evaluation. During the surgeries, the mid-crestal incision and intra-crevicular incision were made following local articaine infiltration anesthesia. No releasing incisions were made. After full-thickness flaps were elevated labially and lingually to expose the alveolar ridge, the implants were placed according to the standard surgical procedures defined by the manufacturer. After a healing time of 10-16 weeks, implant-level impressions were taken. The porcelain (Ivoclar-Vivadent AG, Schaan, Lichtenstein) fused to noble metal crowns were fabricated. Abutment screws were torqued to 15 Ncm. Crowns were cemented with HY-bond Glassionomer Cement
| Study group | Role | What they receive |
|---|---|---|
| single crowns supported by implants | single crowns supported by implants placed in the anterior maxilla region, periodontally healthy Receives: Procedure: single crowns supported by implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
aesthetic scores
The photos were taken 1 hour after cementation of the crowns Digital camera will being used during the examinations (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan).
The evaluation will be based on the pictures of the prosthesis and soft tissue around the crown which supported by implant.
7 parameters will be assessed for PES :mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture.
5 parameters will be assessed for WES:general tooth form; outline and volume of the clinical crown; color; surface texture; and translucency and characterization.
For both PES and WES, the score of 2, 1, or 0 is assigned to each parameter by certain evaluation standard
Measured: baseline
aesthetic scores
The pictures were taken routinely during patients's revisit . The PES will be assessed via photographs, in order to evaluate the changes of the soft tissue around the crown.
WES will not be evaluated at this time point.
Measured: 6-10 months after crown placement
aesthetic scores
The photos will be taken by the same digital camera (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan)
both PES and WES will be evaluated at this time point
Measured: 5-8 years after crown placement
Secondary outcomes (4)
Modified plaque index (mPLI)
The mPLI will be recorded at four sites (mesial, distal, buccal and palatal) around each of the implant-supported single crowns by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe
, Hu-Friedy).
Measured: 5-8 years after restoration
marginal bone resorption
As routine postoperative examination, peri-apical radiographs were taken for all the patients with the long-cone technique at the time when the crowns were cemented. And the latest radiographs will be taken at the time of the last revisit. All of the radiographic films were scanned at 600 dpi with a scanner and the marginal bone level will be assessed with image analysis software.The distance between implant shoulder and first visible bone-to-implant contact (BID) will be measured on the mesial and distal aspects. For each implant and each examination period, the values will be calculated as the average of the obtained mesial and distal values.
Measured: 5-8 years after restoration
Modified sulcus bleeding index (mSBI)
mSBI will recorded at four sites (mesial, distal, buccal and palatal) around each of the implant-supported single crowns by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe, Hu-Friedy)
Measured: 5-8 years after crown placement
probing depth (PD)
The peri-implant probing depth was recorded by a periodontal probe (15 UNC/CP-11.5B Screening Color-Coded Probe
, Hu-Friedy) at the four sites too (Mesial, Distal, buccal, lingual). The recordings were made to the nearest millimeter.
Measured: 5-8 years after crown placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Poor Aesthetics of Existing RestorationStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongchang Lai, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Hongchang Lai, DDS, Study director, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061930
- Sponsor's protocol ID
- Shanghai9
- Acronym
- PES/WES
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 13 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
PubMed 16307569Belser U, Buser D, Higginbottom F. Consensus statements and recommended clinical procedures regarding esthetics in implant dentistry. Int J Oral Maxillofac Implants. 2004;19 Suppl:73-4. No abstract available.
PubMed 15635947Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.
PubMed 19228100Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
PubMed 23347346Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
PubMed 15839587Henriksson K, Jemt T. Measurements of soft tissue volume in association with single-implant restorations: a 1-year comparative study after abutment connection surgery. Clin Implant Dent Relat Res. 2004;6(4):181-9. doi: 10.1111/j.1708-8208.2004.tb00034.x.
PubMed 15841578Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x.
PubMed 21752044Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17.
PubMed 20662859Lai HC, Zhang ZY, Wang F, Zhuang LF, Liu X, Pu YP. Evaluation of soft-tissue alteration around implant-supported single-tooth restoration in the anterior maxilla: the pink esthetic score. Clin Oral Implants Res. 2008 Jun;19(6):560-4. doi: 10.1111/j.1600-0501.2008.01522.x.
PubMed 18474062Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. doi: 10.1111/j.1600-0501.2005.01128.x.
PubMed 16307570Gallucci GO, Grutter L, Nedir R, Bischof M, Belser UC. Esthetic outcomes with porcelain-fused-to-ceramic and all-ceramic single-implant crowns: a randomized clinical trial. Clin Oral Implants Res. 2011 Jan;22(1):62-9. doi: 10.1111/j.1600-0501.2010.01997.x. Epub 2010 Sep 24.
PubMed 21158931Dierens M, de Bruecker E, Vandeweghe S, Kisch J, de Bruyn H, Cosyn J. Alterations in soft tissue levels and aesthetics over a 16-22 year period following single implant treatment in periodontally-healthy patients: a retrospective case series. J Clin Periodontol. 2013 Mar;40(3):311-8. doi: 10.1111/jcpe.12049. Epub 2013 Jan 9.
PubMed 23297745
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Soft Tissue Stability Around Single Crowns Supported by Tissue Level Implants Placed in Non-augmented Healed Sites in the Anterior Maxilla: a Retrospective Study
- ClinicalTrials.gov ID
- NCT02061930
- Acronym / sponsor ID
- PES/WES / Shanghai9
- Conditions
- Poor Aesthetics of Existing Restoration
- Keywords
- single tooth, dental implant, aesthetics outcome, long term, soft tissue recession, pink esthetic score, white esthetic score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 13 Feb 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.
The aim of this study is to review the long-term soft tissue stability and the long-term esthetic results of single crowns supported by tissue level implants placed in non-augmented healed sites.
The hypothesis of the present study is that tissue level implants can achieve ideal esthetic outcomes in non-augmented healed sites.
Detailed description
Both successful implant-supported restorations and the peri-implant soft and hard tissues are vital determinants which may affect the short- and long-term aesthetic outcomes.
For this reason, the pink aesthetic score (PES) was introduced for the evaluation of peri-implant soft tissues by Fürhauser in 2005 and modified by Belser as PES/WES in 2009.
So far, a series of clinical studies have confirmed the suitability of PES/WES and PES index for the objective outcome assessment of the aesthetic dimension of anterior single-tooth implants.
However, to our knowledge, studies with long term data of the aesthetic outcome evaluation in non-augmented healed sites of the anterior maxilla are still rare, for most of the papers published recently mainly focused on immediate implant placement after tooth extraction with only 1-5 years following up.
In our previous study, we have evaluated the alterations of soft tissue around implant-supported single crowns in the anterior maxilla with original standard PES at the time of crown placement and 6 months post-loading .We have found that the aesthetic outcome of soft tissue around the single-tooth implant had improved significantly at follow-up compared with baseline according to PES assessment. However, the follow up time of the previous study was short (6-8 months), long time follow up is necessary to confirm the previous hypothesis and observations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single crowns supported by implants | – | Procedure: single crowns supported by implantssingle crowns supported by implants placed in the anterior maxilla region, periodontally healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Have at least one implant-supported single crown in the anterior maxilla region (13-23) with Straumann (Institute Straumann AG, Waldenburg, Switzerland) tissue level implants placed between December 2005 and October 2008.
Key inclusion criteria (8 listed)
- Have had the tooth extraction at least 3 months before implant surgery.
- Did not receive soft or hard tissue augmentation before or in conjunction with implant surgery.
- Did not receive restorative treatment of the adjacent teeth.
- Underwent conventional healing and loading protocol after implant surgery.
- Have both neighboring teeth and corresponding teeth in the mandible.
Key exclusion criteria (2 listed)
- Patients who don't fulfill the inclusion criteria
- Patients who refused to join the study
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 |
|---|---|---|
| single crowns supported by implantsAlso: Straumann dental implants SLA spThe implant placement procedures were planned based on clinical and radiographic evaluation. During the surgeries, the mid-crestal incision and intra-crevicular incision were made following local articaine infiltration anesthesia. No releasing incisions were made. After full-thickness flaps were elevated labially and lingually to expose the alveolar ridge, the implants were placed according to the standard surgical procedures defined by the manufacturer. After a healing time of 10-16 weeks, implant-level impressions were taken. The porcelain (Ivoclar-Vivadent AG, Schaan, Lichtenstein) fused to noble metal crowns were fabricated. Abutment screws were torqued to 15 Ncm. Crowns were cemented with HY-bond Glassionomer Cement | Procedure or surgery | single crowns supported by implants |
Primary outcome
aesthetic scores
Time frame: baseline
The photos were taken 1 hour after cementation of the crowns Digital camera will being used during the examinations (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan). The evaluation will be based on the pictures of the prosthesis and soft tissue around the crown which supported by implant. 7 parameters will be assessed for PES :mesial papilla, distal papilla, soft-tissue level, soft-tissue contour, alveolar process deficiency, soft-tissue color and texture. 5 parameters will be assessed for WES:general tooth form; outline and volume of the clinical crown; color; surface texture; and translucency and characterization. For both PES and WES, the score of 2, 1, or 0 is assigned to each parameter by certain evaluation standard
aesthetic scores
Time frame: 6-10 months after crown placement
The pictures were taken routinely during patients's revisit . The PES will be assessed via photographs, in order to evaluate the changes of the soft tissue around the crown. WES will not be evaluated at this time point.
aesthetic scores
Time frame: 5-8 years after crown placement
The photos will be taken by the same digital camera (Nikon D70, Nikon Medical Objective circular flash; Nikon Corporation, Tokyo, Japan) both PES and WES will be evaluated at this time point
4 secondary outcomes
Modified plaque index (mPLI)
Time frame: 5-8 years after restoration
marginal bone resorption
Time frame: 5-8 years after restoration
Modified sulcus bleeding index (mSBI)
Time frame: 5-8 years after crown placement
probing depth (PD)
Time frame: 5-8 years after crown placement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- Background: PubMed 16307569Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.
- Background: PubMed 15635947Belser U, Buser D, Higginbottom F. Consensus statements and recommended clinical procedures regarding esthetics in implant dentistry. Int J Oral Maxillofac Implants. 2004;19 Suppl:73-4. No abstract available.
- Background: PubMed 19228100Belser UC, Grutter L, Vailati F, Bornstein MM, Weber HP, Buser D. Outcome evaluation of early placed maxillary anterior single-tooth implants using objective esthetic criteria: a cross-sectional, retrospective study in 45 patients with a 2- to 4-year follow-up using pink and white esthetic scores. J Periodontol. 2009 Jan;80(1):140-51. doi: 10.1902/jop.2009.080435.
- Background: PubMed 23347346Buser D, Chappuis V, Bornstein MM, Wittneben JG, Frei M, Belser UC. Long-term stability of contour augmentation with early implant placement following single tooth extraction in the esthetic zone: a prospective, cross-sectional study in 41 patients with a 5- to 9-year follow-up. J Periodontol. 2013 Nov;84(11):1517-27. doi: 10.1902/jop.2013.120635. Epub 2013 Jan 24.
- Background: PubMed 15839587Grunder U, Gracis S, Capelli M. Influence of the 3-D bone-to-implant relationship on esthetics. Int J Periodontics Restorative Dent. 2005 Apr;25(2):113-9.
- Background: PubMed 15841578Henriksson K, Jemt T. Measurements of soft tissue volume in association with single-implant restorations: a 1-year comparative study after abutment connection surgery. Clin Implant Dent Relat Res. 2004;6(4):181-9. doi: 10.1111/j.1708-8208.2004.tb00034.x.
- Background: PubMed 21752044Cosyn J, Eghbali A, De Bruyn H, Collys K, Cleymaet R, De Rouck T. Immediate single-tooth implants in the anterior maxilla: 3-year results of a case series on hard and soft tissue response and aesthetics. J Clin Periodontol. 2011 Aug;38(8):746-53. doi: 10.1111/j.1600-051X.2011.01748.x.
- Background: PubMed 20662859Cosyn J, Eghbali A, De Bruyn H, Dierens M, De Rouck T. Single implant treatment in healing versus healed sites of the anterior maxilla: an aesthetic evaluation. Clin Implant Dent Relat Res. 2012 Aug;14(4):517-26. doi: 10.1111/j.1708-8208.2010.00300.x. Epub 2010 Jul 17.
- Results publication: PubMed 18474062Lai HC, Zhang ZY, Wang F, Zhuang LF, Liu X, Pu YP. Evaluation of soft-tissue alteration around implant-supported single-tooth restoration in the anterior maxilla: the pink esthetic score. Clin Oral Implants Res. 2008 Jun;19(6):560-4. doi: 10.1111/j.1600-0501.2008.01522.x.
- Results publication: PubMed 16307570Meijer HJ, Stellingsma K, Meijndert L, Raghoebar GM. A new index for rating aesthetics of implant-supported single crowns and adjacent soft tissues--the Implant Crown Aesthetic Index. Clin Oral Implants Res. 2005 Dec;16(6):645-9. doi: 10.1111/j.1600-0501.2005.01128.x.
- Results publication: PubMed 21158931Gallucci GO, Grutter L, Nedir R, Bischof M, Belser UC. Esthetic outcomes with porcelain-fused-to-ceramic and all-ceramic single-implant crowns: a randomized clinical trial. Clin Oral Implants Res. 2011 Jan;22(1):62-9. doi: 10.1111/j.1600-0501.2010.01997.x. Epub 2010 Sep 24.
- Results publication: PubMed 23297745Dierens M, de Bruecker E, Vandeweghe S, Kisch J, de Bruyn H, Cosyn J. Alterations in soft tissue levels and aesthetics over a 16-22 year period following single implant treatment in periodontally-healthy patients: a retrospective case series. J Clin Periodontol. 2013 Mar;40(3):311-8. doi: 10.1111/jcpe.12049. Epub 2013 Jan 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.
Hongchang Lai, DDS study director
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poor Aesthetics of Existing Restoration, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
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 8 inclusion and 2 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 13 Feb 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Zhao, phd (13331169917, pig3333@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aesthetic scores (time frame: baseline). The study lists 3 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 NCT02061930, which also lists 12 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 Feb 2014.