Cleft LipACCQUIREnetNCT02702869
Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)
An observational study of Cleft Lip and Cleft Palate, run by Duke University at 11 sites in 2 countries.
Trial summary
The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes… Read more about this study
- Who is it for?
- Ages 1 day to 22 years
- Conditions the study is for
- Cleft Lip, Cleft Palate, Cleft Lip and Palate
- What is being tested?
- cleft lip repair, cleft palate repair and oronasal fistula repair
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 1,000 participants
- Where
- 11 sitesin 2 countries
- Study dates
- Oct 2016to Dec 2031
- How long will I take part?
- 22 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 1 day to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All patients born with cleft lip and/or palate are eligible for inclusion in this study.
Who may be able to join
- Typical orofacial clefts, of which subtypes are:
- Unilateral or bilateral cleft lip
- Unilateral or bilateral cleft lip and alveolus
- Unilateral or bilateral cleft lip and alveolus and palate
- Unilateral or bilateral cleft lip and palate
- Overt cleft palate
- Occult cleft palate
Who cannot join
- Atypical (Tessier) facial clefts
Trial locations and contacts
11 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
11 sites in 2 countries
United States10 sites
Harvard University - Boston Children's Hospital (BCH)
Boston, Massachusetts, 02115
Duke University - Duke Children's Hospital & Health Center
Durham, North Carolina, 27710
University of Florida - Shands Hospital
Gainesville, Florida, 32608
Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
University of Texas at Houston - Children's Memorial Hermann Hospital
Houston, Texas, 77030
Orlando Health - Arnold Palmer Hospital for Children
Orlando, Florida, 32806
Maine Medical Center
Portland, Maine, 04102
Washington University - St. Louis Children's Hospital (WUSTL)
St Louis, Missouri, 63110
Johns Hopkins - All Children's Hospital (JHACH)
St. Petersburg, Florida, 33701
Wake Forest University - Brenner Children's Hospital
Winston-Salem, North Carolina, 27157
Canada1 site
Dalhousie University - IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
About this study
Official title: Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care
The Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.
Read the detailed description
The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.
Adoption of this prospective data-collection system has two principal goals:
- To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and
- To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)
All patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.
The IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.
- Conditions
- Cleft Lip, Cleft Palate, Cleft Lip and Palate
- Being tested
- cleft lip repair, cleft palate repair, oronasal fistula repair, pharyngoplasty, gingivoperiosteoplasty
- Keywords
- cleft lip, cleft palate, cleft lip and palate, cleft alveolus, multidisciplinary team, interdisciplinary team
- Medical subject headings
- Cleft Lip, Cleft Palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cleft lip repairProcedure or surgery
Also called cheiloplasty
cleft palate repairProcedure or surgery
Also called palatoplasty
oronasal fistula repairProcedure or surgery
pharyngoplastyProcedure or surgery
Also called sphincteroplasty
gingivoperiosteoplastyProcedure or surgery
LeFort-1 maxillary repositioningProcedure or surgery
Also called orthognathic surgery
rhinoplastyProcedure or surgery
myringotomy and tympanostomy tube placementProcedure or surgery
speech therapyOther
orthodontiaProcedure or surgery
presurgical orthopedicsProcedure or surgery
Also called nasoalveolar molding, dentofacial orthopedics, Georgiade-Latham appliance, Latham appliance
sound amplification for hearingDevice
Also called hearing aid
| Study group | Role | What they receive |
|---|---|---|
| uCL(A) | Children with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). Receives: Procedure: cleft lip repair; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics | |
| uCL(A)P | Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). Receives: Procedure: cleft lip repair; Procedure: cleft palate repair; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Procedure: myringotomy and tympanostomy tube placement; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Device: sound amplification for hearing | |
| bCL(A) | Children with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). Receives: Procedure: cleft lip repair; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics | |
| bCL(A)P | Children with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). Receives: Procedure: cleft lip repair; Procedure: cleft palate repair; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Procedure: gingivoperiosteoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: rhinoplasty; Procedure: myringotomy and tympanostomy tube placement; Other: speech therapy; Procedure: orthodontia; Procedure: presurgical orthopedics; Device: sound amplification for hearing | |
| CP | Children with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). Receives: Procedure: cleft palate repair; Procedure: oronasal fistula repair; Procedure: pharyngoplasty; Procedure: LeFort-1 maxillary repositioning; Procedure: myringotomy and tympanostomy tube placement; Other: speech therapy; Device: sound amplification for hearing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Measured: ~5 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Measured: ~8 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Measured: ~12 years of age
Speech: intelligibility
Utilizes the intelligibility in context scale (ICS)
Measured: ~22 years of age
Speech: velopharyngeal competence
Measured: ~5 years of age
Speech: velopharyngeal competence
Measured: ~8 years of age
Speech: velopharyngeal competence
Measured: ~12 years of age
Speech: velopharyngeal competence
Measured: ~22 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Measured: ~5 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Measured: ~8 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Measured: ~12 years of age
Speech: articulation
Utilizes the modified percent correct consonants (mPCC) scale
Measured: ~22 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Measured: ~8 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Measured: ~12 years of age
Speech: patient-reported outcomes related to speech and speaking
Utilizes the CLEFT-Q PROM
Measured: ~22 years of age
Hearing: puretone average
Measured: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Measured: ~5 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Measured: ~12 years of age
Dental: dmft and DMFT scores
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Measured: ~22 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Measured: ~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Measured: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Measured: ~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Measured: ~12 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Measured: ~22 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Measured: ~22 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Measured: ~8 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Measured: ~12 years of age
Dental: patient-reported outcomes related to mastication
Uses the CLEFT-Q PROM
Measured: ~22 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Measured: ~8 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Measured: ~12 years of age
Dental: patient-reported outcomes related to oral health
Uses the COHIP PROM
Measured: ~22 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Measured: ~8 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Measured: ~12 years of age
Patient-reported outcomes related to eating/drinking
Uses the CLEFT-Q PROM
Measured: ~22 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Measured: ~8 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Measured: ~12 years of age
Breathing: Patient-reported outcomes related to nasal and oral breathing
Uses the NOSE PROM
Measured: ~22 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Measured: ~8 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Measured: ~12 years of age
Aesthetics: Patient-reported outcomes related to appearance
Uses the CLEFT-Q PROM
Measured: ~22 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Measured: ~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Measured: ~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Measured: ~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Measured: ~12 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Measured: ~22 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft LipStudies of the same condition, open and under way.
- More trials run by Duke 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 22 Years
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander C Allori, MD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02702869
- Sponsor's protocol ID
- Pro00104806
- Acronym
- ACCQUIREnet
- Status last verified
- Jan 2026
- First submitted
- 16 Oct 2015
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: This is a collaborative research network. All data processing happens at the coordinating center, with results reviewed by the participating centers.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet): Prospective Data-collection System and Learning Health-care Network for the Comprehensive Appraisal of Cleft and Craniofacial Care
- ClinicalTrials.gov ID
- NCT02702869
- Acronym / sponsor ID
- ACCQUIREnet / Pro00104806
- Conditions
- Cleft Lip, Cleft Palate, Cleft Lip and Palate
- Keywords
- cleft lip, cleft palate, cleft lip and palate, cleft alveolus, multidisciplinary team, interdisciplinary team
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 9 Mar 2016 (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 Allied Cleft \& Craniofacial Quality-Improvement and Research Network (ACCQUIREnet) is a group of multidisciplinary cleft teams that have implemented a system for prospective collection of outcomes data, based on the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, CLEFT-Q, and other outcomes instruments. Participating cleft teams may analyze clinical and psychosocial outcomes related to care of the child with cleft lip and/or palate (CL/P), compare its performance with those of other cleft centers, and identify opportunities for quality improvement.
Detailed description
The purpose of this project is to implement a system of prospective, standardized data collection for all patients with cleft lip and/or palate (CL/P) treated by the cleft and craniofacial centers that participate in ACCQUIREnet.
Adoption of this prospective data-collection system has two principal goals:
- To enable on-demand and scheduled review of cleft-care-related safety and outcomes data and team performance for the purpose of internal audits and continuous quality improvement; and
- To permit participation in multi-site, collaborative quality-improvement projects and/or research networks that require usage of these standardized data-collection methods. (These collaborations are described in corresponding IRB protocols and data-transfer agreements. Patient privacy and confidentiality is protected at all times.)
All patients with CL/P treated at cleft and craniofacial centers participating in ACCQUIREnet will be invited to participate in this project. Duke University serves as the coordinating center and statistical support center for the study. Data are maintained in a local, secured database.
The IRB protocol details methods of quality assurance, data monitoring, and auditing. Data dictionaries employed in ACCQUIREnet include the CleftCap REDCap project template, CleftKit Common Data Model (an extension of the PCORnet Common Data Model), the ICHOM Standard Set for the Comprehensive Appraisal of Cleft Care, and the CLEFT-Q patient-reported outcome manual, maintained by the International Consortium for Health Outcomes Measurement (ichom.org) and McMaster University, respectively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 22 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| uCL(A) | – | Procedure: cleft lip repair, Procedure: gingivoperiosteoplasty, Procedure: LeFort-1 maxillary repositioning, Procedure: rhinoplasty, Other: speech therapy, Procedure: orthodontia, Procedure: presurgical orthopedicsChildren with unilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). |
| uCL(A)P | – | Procedure: cleft lip repair, Procedure: cleft palate repair, Procedure: oronasal fistula repair, Procedure: pharyngoplasty, Procedure: gingivoperiosteoplasty, Procedure: LeFort-1 maxillary repositioning, Procedure: rhinoplasty, Procedure: myringotomy and tympanostomy tube placement, Other: speech therapy, Procedure: orthodontia, Procedure: presurgical orthopedics, Device: sound amplification for hearingChildren with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, or Veau-III). |
| bCL(A) | – | Procedure: cleft lip repair, Procedure: gingivoperiosteoplasty, Procedure: LeFort-1 maxillary repositioning, Procedure: rhinoplasty, Other: speech therapy, Procedure: orthodontia, Procedure: presurgical orthopedicsChildren with bilateral cleft lip with/without cleft alveolus but intact secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form). |
| bCL(A)P | – | Procedure: cleft lip repair, Procedure: cleft palate repair, Procedure: oronasal fistula repair, Procedure: pharyngoplasty, Procedure: gingivoperiosteoplasty, Procedure: LeFort-1 maxillary repositioning, Procedure: rhinoplasty, Procedure: myringotomy and tympanostomy tube placement, Other: speech therapy, Procedure: orthodontia, Procedure: presurgical orthopedics, Device: sound amplification for hearingChildren with unilateral cleft lip with/without cleft alveolus and with cleft secondary palate. Subgroup analysis by severity of lip (complete, incomplete, or lesser-form) and severity of palate (submucous, Veau-I, Veau-II, Veau-III, or Veau-IV). |
| CP | – | Procedure: cleft palate repair, Procedure: oronasal fistula repair, Procedure: pharyngoplasty, Procedure: LeFort-1 maxillary repositioning, Procedure: myringotomy and tympanostomy tube placement, Other: speech therapy, Device: sound amplification for hearingChildren with cleft secondary palate only, but intact lip and alveolus. Subgroup analysis by severity (submucous, Veau-I, or Veau-II). |
Who may qualify
- Ages
- 1 day to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All patients born with cleft lip and/or palate are eligible for inclusion in this study.
Key inclusion criteria (7 listed)
- Typical orofacial clefts, of which subtypes are:
- Unilateral or bilateral cleft lip
- Unilateral or bilateral cleft lip and alveolus
- Unilateral or bilateral cleft lip and alveolus and palate
- Unilateral or bilateral cleft lip and palate
Key exclusion criteria (1 listed)
- Atypical (Tessier) facial clefts
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 |
|---|---|---|
| cleft lip repairAlso: cheiloplasty | Procedure or surgery | bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| cleft palate repairAlso: palatoplasty | Procedure or surgery | CP, bCL(A)P, uCL(A)P |
| oronasal fistula repair | Procedure or surgery | CP, bCL(A)P, uCL(A)P |
| pharyngoplastyAlso: sphincteroplasty | Procedure or surgery | CP, bCL(A)P, uCL(A)P |
| gingivoperiosteoplasty | Procedure or surgery | bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| LeFort-1 maxillary repositioningAlso: orthognathic surgery | Procedure or surgery | CP, bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| rhinoplasty | Procedure or surgery | bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| myringotomy and tympanostomy tube placement | Procedure or surgery | CP, bCL(A)P, uCL(A)P |
| speech therapy | Other | CP, bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| orthodontia | Procedure or surgery | bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| presurgical orthopedicsAlso: nasoalveolar molding, dentofacial orthopedics, Georgiade-Latham appliance, Latham appliance | Procedure or surgery | bCL(A), bCL(A)P, uCL(A), uCL(A)P |
| sound amplification for hearingAlso: hearing aid | Device | CP, bCL(A)P, uCL(A)P |
Primary outcome
Speech: intelligibility
Time frame: ~5 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility
Time frame: ~8 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility
Time frame: ~12 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: intelligibility
Time frame: ~22 years of age
Utilizes the intelligibility in context scale (ICS)
Speech: velopharyngeal competence
Time frame: ~5 years of age
Speech: velopharyngeal competence
Time frame: ~8 years of age
Speech: velopharyngeal competence
Time frame: ~12 years of age
Speech: velopharyngeal competence
Time frame: ~22 years of age
Speech: articulation
Time frame: ~5 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation
Time frame: ~8 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation
Time frame: ~12 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: articulation
Time frame: ~22 years of age
Utilizes the modified percent correct consonants (mPCC) scale
Speech: patient-reported outcomes related to speech and speaking
Time frame: ~8 years of age
Utilizes the CLEFT-Q PROM
Speech: patient-reported outcomes related to speech and speaking
Time frame: ~12 years of age
Utilizes the CLEFT-Q PROM
Speech: patient-reported outcomes related to speech and speaking
Time frame: ~22 years of age
Utilizes the CLEFT-Q PROM
Hearing: puretone average
Time frame: ~5 years of age
Dental: dmft and DMFT scores
Time frame: ~5 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: dmft and DMFT scores
Time frame: ~12 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: dmft and DMFT scores
Time frame: ~22 years of age
Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~5 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~12 years of age
Dental: occlusion (Uses modifications of the GOSLON scale)
Time frame: ~22 years of age
Dental: occlusion (Uses modifications of the Bauru scale)
Time frame: ~22 years of age
Dental: patient-reported outcomes related to mastication
Time frame: ~8 years of age
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to mastication
Time frame: ~12 years of age
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to mastication
Time frame: ~22 years of age
Uses the CLEFT-Q PROM
Dental: patient-reported outcomes related to oral health
Time frame: ~8 years of age
Uses the COHIP PROM
Dental: patient-reported outcomes related to oral health
Time frame: ~12 years of age
Uses the COHIP PROM
Dental: patient-reported outcomes related to oral health
Time frame: ~22 years of age
Uses the COHIP PROM
Patient-reported outcomes related to eating/drinking
Time frame: ~8 years of age
Uses the CLEFT-Q PROM
Patient-reported outcomes related to eating/drinking
Time frame: ~12 years of age
Uses the CLEFT-Q PROM
Patient-reported outcomes related to eating/drinking
Time frame: ~22 years of age
Uses the CLEFT-Q PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing
Time frame: ~8 years of age
Uses the NOSE PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing
Time frame: ~12 years of age
Uses the NOSE PROM
Breathing: Patient-reported outcomes related to nasal and oral breathing
Time frame: ~22 years of age
Uses the NOSE PROM
Aesthetics: Patient-reported outcomes related to appearance
Time frame: ~8 years of age
Uses the CLEFT-Q PROM
Aesthetics: Patient-reported outcomes related to appearance
Time frame: ~12 years of age
Uses the CLEFT-Q PROM
Aesthetics: Patient-reported outcomes related to appearance
Time frame: ~22 years of age
Uses the CLEFT-Q PROM
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~2 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~5 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~8 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~12 years of age
Aesthetics: Clinical assessment of nasolabial and facial aesthetics
Time frame: ~22 years of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Duke Cleft \& Craniofacial CenterLink provided by the sponsor.
- Official web site for ICHOM Standard Set for cleft lip and/or palate, upon which the Duke project is basedLink provided by the sponsor.
- ACCQUIREnet web siteLink provided by the sponsor.
- Individual participant dataSharing planned: No. This is a collaborative research network. All data processing happens at the coordinating center, with results reviewed by the participating centers.
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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.
Alexander C Allori, MD, MPH principal investigator
Duke University
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Cleft Palate, run by Duke University at 11 sites in 2 countries.
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 7 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Speech: intelligibility (time frame: ~5 years of age). The study lists 45 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.