NCT02702869

Allied Cleft & Craniofacial Quality-Improvement and Research Network (ACCQUIREnet)

Enrolling by Invitation
Not specifiedAges 1–22Observational
Duke University
~1,000 participants
Updated 2026-01-07 on ClinicalTrials.gov
What's tested:cleft lip repaircleft palate repairoronasal fistula repairpharyngoplastygingivoperiosteoplastyLeFort-1 maxillary repositioning

At a glance

Recruiting sites
0 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Speech: intelligibility
Measured over ~5 years of age
+44 more outcomes measured
Cleft Lip
Cleft Palate
Cleft Lip and Palate
11 sites across 7 states
Florida4
North Carolina2
Maine1
Massachusetts1
Missouri1
Texas1
Nova Scotia1
  • Alexander C Allori, MD, MPH · PRINCIPAL_INVESTIGATOR · Duke University

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

Atypical (Tessier) facial clefts
  • Speech: intelligibility~5 years of age

    Utilizes the intelligibility in context scale (ICS)

  • Speech: intelligibility~8 years of age

    Utilizes the intelligibility in context scale (ICS)

  • Speech: intelligibility~12 years of age

    Utilizes the intelligibility in context scale (ICS)

  • Speech: intelligibility~22 years of age

    Utilizes the intelligibility in context scale (ICS)

  • Speech: velopharyngeal competence~5 years of age
  • Speech: velopharyngeal competence~8 years of age
  • Speech: velopharyngeal competence~12 years of age
  • Speech: velopharyngeal competence~22 years of age
  • Speech: articulation~5 years of age

    Utilizes the modified percent correct consonants (mPCC) scale

  • Speech: articulation~8 years of age

    Utilizes the modified percent correct consonants (mPCC) scale

  • Speech: articulation~12 years of age

    Utilizes the modified percent correct consonants (mPCC) scale

  • Speech: articulation~22 years of age

    Utilizes the modified percent correct consonants (mPCC) scale

  • Speech: patient-reported outcomes related to speech and speaking~8 years of age

    Utilizes the CLEFT-Q PROM

  • Speech: patient-reported outcomes related to speech and speaking~12 years of age

    Utilizes the CLEFT-Q PROM

  • Speech: patient-reported outcomes related to speech and speaking~22 years of age

    Utilizes the CLEFT-Q PROM

  • Hearing: puretone average~5 years of age
  • Dental: dmft and DMFT scores~5 years of age

    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  • Dental: dmft and DMFT scores~12 years of age

    Utilizes the dmft score for deciduous teeth and DMFT score for permanent teeth

  • Dental: dmft and DMFT scores~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)~5 years of age
  • Dental: occlusion (Uses modifications of the Bauru scale)~5 years of age
  • Dental: occlusion (Uses modifications of the GOSLON scale)~12 years of age
  • Dental: occlusion (Uses modifications of the Bauru scale)~12 years of age
  • Dental: occlusion (Uses modifications of the GOSLON scale)~22 years of age
  • Dental: occlusion (Uses modifications of the Bauru scale)~22 years of age
  • Dental: patient-reported outcomes related to mastication~8 years of age

    Uses the CLEFT-Q PROM

  • Dental: patient-reported outcomes related to mastication~12 years of age

    Uses the CLEFT-Q PROM

  • Dental: patient-reported outcomes related to mastication~22 years of age

    Uses the CLEFT-Q PROM

  • Dental: patient-reported outcomes related to oral health~8 years of age

    Uses the COHIP PROM

  • Dental: patient-reported outcomes related to oral health~12 years of age

    Uses the COHIP PROM

  • Dental: patient-reported outcomes related to oral health~22 years of age

    Uses the COHIP PROM

  • Patient-reported outcomes related to eating/drinking~8 years of age

    Uses the CLEFT-Q PROM

  • Patient-reported outcomes related to eating/drinking~12 years of age

    Uses the CLEFT-Q PROM

  • Patient-reported outcomes related to eating/drinking~22 years of age

    Uses the CLEFT-Q PROM

  • Breathing: Patient-reported outcomes related to nasal and oral breathing~8 years of age

    Uses the NOSE PROM

  • Breathing: Patient-reported outcomes related to nasal and oral breathing~12 years of age

    Uses the NOSE PROM

  • Breathing: Patient-reported outcomes related to nasal and oral breathing~22 years of age

    Uses the NOSE PROM

  • Aesthetics: Patient-reported outcomes related to appearance~8 years of age

    Uses the CLEFT-Q PROM

  • Aesthetics: Patient-reported outcomes related to appearance~12 years of age

    Uses the CLEFT-Q PROM

  • Aesthetics: Patient-reported outcomes related to appearance~22 years of age

    Uses the CLEFT-Q PROM

  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics~2 years of age
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics~5 years of age
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics~8 years of age
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics~12 years of age
  • Aesthetics: Clinical assessment of nasolabial and facial aesthetics~22 years of age