Cleft Lip and PalateNCT03395015
Efficacy of Maxillo-facial Treatment on Cleft Lip and Palate Patients Faces: Aesthetic Considerations
An observational study of Cleft Lip and Palate and Growth and Development, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients. The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople. Read more about this study
- Who is it for?
- Ages 20 to 25 years
- Conditions the study is for
- Cleft Lip and Palate, Growth and Development, Cicatrix
- What is being tested?
- VAS scale (from 1 to 10) esthetic assessment of facial 3-D images
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 5 Jun 2017to 22 Dec 2017
- 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 20 to 25 years
- All sexes
- No healthy volunteers
- Adult
Study population: The lay panel consisted of 50 undergraduate students who had little or no training in cleft palate or cranio-facial treatment. All panelists were recruited from the Catholic University of Sacred Heart. The participation of the study is voluntary. A preliminary assessment of raters' knowledge has been performed through an oral examination.
Who may be able to join
- age, between 20 and 25 years
- sex, in order to have at least 25 male and female raters
- sociocultural status: the layperson panel includes undergraduate students without extensive professional knowledge on cleft lip and palate patients
Who cannot join
- previous participation in research studies
- familiarity or close friendship with cleft lip and palate patients
- lack of blindness about the study protocol (it could bias the reported results)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche
The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients.
The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.
Read the detailed description
The management of cleft lip and palate patient's generally involves the soft palate reconstruction as well as the repair of lip and nasal soft tissue defects.
From an esthetic point of view, the primary repair, usually performed between 9 and 18 months of age, prepares the patients to grow into childhood and succeed in life without focusing on their deformity.
An increasing number of outcome measure rating systems has been raised, suggesting a lack of consensus to a reliable, validated and reproducible scoring system for facial aesthetics in cleft patients. Many templates and lay panel scoring systems have been described, yet never fully validated. Advanced 3D imaging technologies may produce validated outcome measures in the future, but presently there remains a need to develop a robust method of facial aesthetic evaluation based on standardised patient photographs.
The aim of the study is to to determine and compare the level of agreement among examiners' subjective aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople, developing some recommendations for a consistent scoring protocol.
- Being tested
- VAS scale (from 1 to 10) esthetic assessment of facial 3-D images
- Keywords
- Reconstructive surgical procedures, Therapy, soft tissue, Treatment outcome, Outcome Assessment (Health Care), Photogrammetry, Physical Appearance, Body
- Medical subject headings
- Cleft Lip, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAS scale (from 1 to 10) esthetic assessment of facial 3-D imagesOther
The rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order.
| Study group | Role | What they receive |
|---|---|---|
| Full-face 3-D images | 3-D images acquisition of CLP patients' faces at rest is set at different timepoints: 1 week preoperative, 1- and 6-months postoperative. Therefore, laypeople's assessment of the facial appearance of CLP patients is based on full facial views. Receives: Other: VAS scale (from 1 to 10) esthetic assessment of facial 3-D images | |
| Nasolabial 3-D images | The control group is composed of cropped 3-D images of CLP patients' faces at rest, which show isolated nasolabial regions of CLP patients. The judgement of these pictures warrants an assessment based solely on the nasolabial appearance. Receives: Other: VAS scale (from 1 to 10) esthetic assessment of facial 3-D images |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intrarater and interrater consistency
The primary outcome of this study is to compare intrarater and interrater reliability of the ratings in both groups.
The reliability of a panel of 3 and 6 judges for the different scoreswere estimated by using the Cronbach alfa formula.
Measured: 3-D images are assessed twice, the timespan between the two evaluations is two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start5 Jun 2017
- Primary completion20 Jul 2017
- Study completion22 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Massimo Cordaro, Dr. Romeo Patini, Dr. Oliva Giorgio, Dr. Candida Ettore, Dr. De Luca Marilisa, Dr. Rizzo Maria Ida, Dr. Zama Mario, Dr. Rajabtork Zadeh Oriana, Dr. Bucci Daria, Prof. Gallenzi Patrizia
- Responsible party
- Principal investigator, Dr. Edoardo Staderini, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Massimo Cordaro, Medicine, Principal investigator, Catholic University of the Sacred Hearth - Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395015
- Sponsor's protocol ID
- 0027003/17
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Iliopoulos C, Mitsimponas K, Lazaridou D, Neukam FW, Stelzle F. A retrospective evaluation of the aesthetics of the nasolabial complex after unilateral cleft lip repair using the Tennison-Randall technique: a study of 44 cases treated in a single cleft center. J Craniomaxillofac Surg. 2014 Dec;42(8):1679-83. doi: 10.1016/j.jcms.2014.05.013. Epub 2014 May 24.
PubMed 24962045Eichenberger M, Staudt CB, Pandis N, Gnoinski W, Eliades T. Facial attractiveness of patients with unilateral cleft lip and palate and of controls assessed by laypersons and professionals. Eur J Orthod. 2014 Jun;36(3):284-9. doi: 10.1093/ejo/cjt047. Epub 2013 Jul 5.
PubMed 23832974de Ladeira PR, Alonso N. Protocols in cleft lip and palate treatment: systematic review. Plast Surg Int. 2012;2012:562892. doi: 10.1155/2012/562892. Epub 2012 Nov 1.
PubMed 23213503Sharma VP, Bella H, Cadier MM, Pigott RW, Goodacre TE, Richard BM. Outcomes in facial aesthetics in cleft lip and palate surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2012 Sep;65(9):1233-45. doi: 10.1016/j.bjps.2012.04.001. Epub 2012 May 15.
PubMed 22591614Stebel A, Desmedt D, Bronkhorst E, Kuijpers MA, Fudalej PS. Rating nasolabial appearance on three-dimensional images in cleft lip and palate: a comparison with standard photographs. Eur J Orthod. 2016 Apr;38(2):197-201. doi: 10.1093/ejo/cjv024. Epub 2015 Apr 21.
PubMed 25900054Mosmuller DG, Bijnen CL, Kramer GJ, Disse MA, Prahl C, Kuik DJ, Niessen FB, Don Griot JP. The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients. J Craniofac Surg. 2015 Jun;26(4):1242-5. doi: 10.1097/SCS.0000000000001784.
PubMed 26080166
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacia Del Trattamento Chirurgico Maxillo-facciale Sul Volto Dei Bambini Con Labiopalatoschisi: Valutazioni Estetiche ed Ortodontiche
- ClinicalTrials.gov ID
- NCT03395015
- Acronym / sponsor ID
- 0027003/17
- Keywords
- Reconstructive surgical procedures, Therapy, soft tissue, Treatment outcome, Outcome Assessment (Health Care), Photogrammetry, Physical Appearance, Body
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Collaborators
- Prof. Massimo Cordaro, Dr. Romeo Patini, Dr. Oliva Giorgio, Dr. Candida Ettore, Dr. De Luca Marilisa, Dr. Rizzo Maria Ida, Dr. Zama Mario, Dr. Rajabtork Zadeh Oriana, Dr. Bucci Daria, Prof. Gallenzi Patrizia
- Study start
- 5 Jun 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 22 Dec 2017 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to analyze the esthetic outcome of the first surgical repair of cleft lip and palate (CLP) patients.
The aim of the study is to identify differences in the aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople.
Detailed description
The management of cleft lip and palate patient's generally involves the soft palate reconstruction as well as the repair of lip and nasal soft tissue defects.
From an esthetic point of view, the primary repair, usually performed between 9 and 18 months of age, prepares the patients to grow into childhood and succeed in life without focusing on their deformity.
An increasing number of outcome measure rating systems has been raised, suggesting a lack of consensus to a reliable, validated and reproducible scoring system for facial aesthetics in cleft patients. Many templates and lay panel scoring systems have been described, yet never fully validated. Advanced 3D imaging technologies may produce validated outcome measures in the future, but presently there remains a need to develop a robust method of facial aesthetic evaluation based on standardised patient photographs.
The aim of the study is to to determine and compare the level of agreement among examiners' subjective aesthetic evaluation of full-face and nasolabial region 3-D images of CLP patients following primary lip repair by laypeople, developing some recommendations for a consistent scoring protocol.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Full-face 3-D images | – | Other: VAS scale (from 1 to 10) esthetic assessment of facial 3-D images3-D images acquisition of CLP patients' faces at rest is set at different timepoints: 1 week preoperative, 1- and 6-months postoperative. Therefore, laypeople's assessment of the facial appearance of CLP patients is based on full facial views. |
| Nasolabial 3-D images | – | Other: VAS scale (from 1 to 10) esthetic assessment of facial 3-D imagesThe control group is composed of cropped 3-D images of CLP patients' faces at rest, which show isolated nasolabial regions of CLP patients. The judgement of these pictures warrants an assessment based solely on the nasolabial appearance. |
Who may qualify
- Ages
- 20 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The lay panel consisted of 50 undergraduate students who had little or no training in cleft palate or cranio-facial treatment. All panelists were recruited from the Catholic University of Sacred Heart. The participation of the study is voluntary. A preliminary assessment of raters' knowledge has been performed through an oral examination.
Key inclusion criteria (3 listed)
- age, between 20 and 25 years
- sex, in order to have at least 25 male and female raters
- sociocultural status: the layperson panel includes undergraduate students without extensive professional knowledge on cleft lip and palate patients
Key exclusion criteria (3 listed)
- previous participation in research studies
- familiarity or close friendship with cleft lip and palate patients
- lack of blindness about the study protocol (it could bias the reported results)
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 |
|---|---|---|
| VAS scale (from 1 to 10) esthetic assessment of facial 3-D imagesThe rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order. | Other | Full-face 3-D images, Nasolabial 3-D images |
Primary outcome
Intrarater and interrater consistency
Time frame: 3-D images are assessed twice, the timespan between the two evaluations is two weeks
The primary outcome of this study is to compare intrarater and interrater reliability of the ratings in both groups. The reliability of a panel of 3 and 6 judges for the different scoreswere estimated by using the Cronbach alfa formula.
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 9 Jan 2018.
- Results publication: PubMed 24962045Iliopoulos C, Mitsimponas K, Lazaridou D, Neukam FW, Stelzle F. A retrospective evaluation of the aesthetics of the nasolabial complex after unilateral cleft lip repair using the Tennison-Randall technique: a study of 44 cases treated in a single cleft center. J Craniomaxillofac Surg. 2014 Dec;42(8):1679-83. doi: 10.1016/j.jcms.2014.05.013. Epub 2014 May 24.
- Results publication: PubMed 23832974Eichenberger M, Staudt CB, Pandis N, Gnoinski W, Eliades T. Facial attractiveness of patients with unilateral cleft lip and palate and of controls assessed by laypersons and professionals. Eur J Orthod. 2014 Jun;36(3):284-9. doi: 10.1093/ejo/cjt047. Epub 2013 Jul 5.
- Results publication: PubMed 23213503de Ladeira PR, Alonso N. Protocols in cleft lip and palate treatment: systematic review. Plast Surg Int. 2012;2012:562892. doi: 10.1155/2012/562892. Epub 2012 Nov 1.
- Results publication: PubMed 22591614Sharma VP, Bella H, Cadier MM, Pigott RW, Goodacre TE, Richard BM. Outcomes in facial aesthetics in cleft lip and palate surgery: a systematic review. J Plast Reconstr Aesthet Surg. 2012 Sep;65(9):1233-45. doi: 10.1016/j.bjps.2012.04.001. Epub 2012 May 15.
- Results publication: PubMed 25900054Stebel A, Desmedt D, Bronkhorst E, Kuijpers MA, Fudalej PS. Rating nasolabial appearance on three-dimensional images in cleft lip and palate: a comparison with standard photographs. Eur J Orthod. 2016 Apr;38(2):197-201. doi: 10.1093/ejo/cjv024. Epub 2015 Apr 21.
- Results publication: PubMed 26080166Mosmuller DG, Bijnen CL, Kramer GJ, Disse MA, Prahl C, Kuik DJ, Niessen FB, Don Griot JP. The Asher-McDade Aesthetic Index in Comparison With Two Scoring Systems in Nonsyndromic Complete Unilateral Cleft Lip and Palate Patients. J Craniofac Surg. 2015 Jun;26(4):1242-5. doi: 10.1097/SCS.0000000000001784.
- Individual participant dataSharing planned: Yes
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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.
Massimo Cordaro, Medicine principal investigator
Catholic University of the Sacred Hearth - Rome
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 Cleft Lip and Palate and Growth and Development, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 3 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 9 Jan 2018. 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 Italy. 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?
Intrarater and interrater consistency (time frame: 3-D images are assessed twice, the timespan between the two evaluations is two weeks). 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 NCT03395015, which also lists 6 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 9 Jan 2018.