9 completed, 2 recruiting, 1 enrolling by invitation, 1 not yet recruiting. 14 Phase 2, 4 Phase 1, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 14 | Completed 9, Recruiting 2, Enrolling by invitation 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 1 | 4 | Completed 3, Recruiting 1 |
| Phase 3 | 1 | Completed 1 |
Follow Mouth Abnormalities: new trials by email Literature Review of Mouth Abnormalities trials Research Report on Mouth Abnormalities
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Cleft Lip Scarring After Botox Botulinum Toxin Type A (BOTOX) Injection, Normal Saline - Cleft Lip, Cleft Lip Scar | Phase 2 | Recruiting | Children's National Research Institute | 40 | 2026-02-19 | 2026-10-19 |
| Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma AdMSC, Placebo - Systemic Scleroderma | Phase 2 | Not yet recruiting | University Hospital, Toulouse | 50 | 2026-01-01 | 2026-01-08 |
| Evaluation of a Novel Nasal Conformer in Pediatric Patients use of an anatomically designed nasal conformer - Cleft Lip, Nasal Surgical Procedures | Phase 2 | Enrolling by invitation | East Tennessee Children's Hospital | 20 | 2025-06-01 | 2026-09-16 |
| Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate. implantation with an autologous human palatal mucosa substitute made of nanostructured fibrin-agarose generated by tissue engineering (BIOCLEFT). - Cleft Lip and Palate | Phase 1 / Phase 2 | Recruiting | Elisa María Cubiles Montero de Espinosa | 15 | 2024-04-17 | 2024-05-10 |
| Suprazygomatic Block in Cleft Palate Surgery in Children Bupivacaine, Dexmedetomidine, paracetamol - Cleft Palate | Phase 2 | Completed | Assiut University | 80 | 2018-01-14 | 2018-09-24 |
| Comparative Study Between Levobupivacaine and Bupivacaine for Nerve Block During Pediatric Primary Cleft Palate Surgery Levobupivacaine, Bupivacaine - Recovery After Cleft Palate Surgery | Phase 2 / Phase 3 | Completed | Assiut University | 60 | 2016-01-01 | 2017-09-07 |
| IV Acetaminophen in Children Undergoing Palatoplasty IV acetaminophen, Placebo - Cleft Palate | Phase 2 | Withdrawn | Nationwide Children's Hospital | 2015-12-01 | 2016-03-08 | |
| Botulinum Toxin to Improve Cosmesis of Primary Cleft Lip Repair Botulinum Toxin Type A, Normal Saline Injection - Cleft Lip, Scarring | Phase 1 / Phase 2 | Completed | The University of Texas Health Science Center, Houston | 30 | 2015-12-01 | 2021-11-03 |
| Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting Using Two Surgical Strategies: Stem Cells and Autogenous Iliac Crest Bone (Pain Evaluation in Children Undergoing Alveolar Grafting: Stem Cells vs. Iliac Crest Bone) Autogenous Iliac Crest Bone Grafting, Bioengineered Alveolar Grafting (SHED + Scaffold) - Clift Lip, Cleft Palate | Phase 1 / Phase 2 | Completed | Hospital Sirio-Libanes | 20 | 2015-03-01 | 2026-07-29 |
| Cell Therapy for Craniofacial Bone Defects Ixmyelocel-T, Autogenous Bone Grafting - Cleft Palate, Trauma | Phase 1 / Phase 2 | Completed | University of Michigan | 18 | 2012-08-01 | 2017-05-04 |
| Does Use of Rigid Fixation After Removing Distraction Osteogenesis Device Reduce the Relapse? mini plate - Cleft Palate, Maxillary Hypoplasia | Phase 2 | Completed | Shiraz University of Medical Sciences | 20 | 2011-02-01 | 2015-01-30 |
| Preventing Complications in Cleft Palate Repair With Antibiotics Unasyn, saline solution - Cleft Palates | Phase 2 | Completed | Joseph Losee | 224 | 2008-05-01 | 2018-02-01 |
| Cleft Orthognathic Surgery Versus Distraction Osteogenesis - Which is Better? Orthognathic surgery, Distraction osteogenesis - Cleft Lip and Palate, Maxillary Hypoplasia | Phase 2 | Completed | The University of Hong Kong | 60 | 2002-06-01 | 2011-09-13 |
| Cleft Palate Surgery and Speech Development Furlow double z-plasty palatoplasty palate repair, Von Langenbeck palatoplasty palate repair - Cleft Lip, Cleft Palate | Phase 2 | Completed | University of Florida | 475 | 1996-02-01 | 2011-09-20 |
Cleft Palate (9) · Cleft Lip (7) · Retrognathia (2) · Alveolar Bone Loss (1) · Cicatrix (1) · Microstomia (1) · Pain, Postoperative (1) · Scleroderma, Systemic (1) · Speech (1) · Wounds and Injuries (1)
Congenital Abnormalities (14) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (14) · Mouth Diseases (14) · Stomatognathic Diseases (14) · Stomatognathic System Abnormalities (14) · Craniofacial Abnormalities (10) · Jaw Abnormalities (10) · Jaw Diseases (10) · Maxillofacial Abnormalities (10) · Musculoskeletal Abnormalities (10) · Musculoskeletal Diseases (10) · Lip Diseases (7) · Mandibular Diseases (2) · Pathologic Processes (2)
Saline Solution (3) · Acetaminophen (2) · Botulinum Toxins, Type A (2) · Bupivacaine (2) · Ampicillin (1) · Dexmedetomidine (1) · Drug Implants (1) · Levobupivacaine (1) · Orthognathic Surgery (1) · Osteogenesis, Distraction (1) · Sodium Chloride (1) · Sulbactam (1) · sultamicillin (1)
Assiut University (2) · Children's National Research Institute (1) · East Tennessee Children's Hospital (1) · Elisa María Cubiles Montero de Espinosa (1) · Hospital Sirio-Libanes (1) · Joseph Losee (1) · Nationwide Children's Hospital (1) · Shiraz University of Medical Sciences (1) · The University of Hong Kong (1) · The University of Texas Health Science Center, Houston (1) · University Hospital, Toulouse (1) · University of Florida (1) · University of Michigan (1)
United States (7) · Brazil (2) · Egypt (2) · France (1) · Hong Kong (1) · Iran (1) · Spain (1)
Darnell Kaigler, DDS, PhD (1) · Jaecel O Shah, MD (1) · Joseph Losee, MD (1) · Lim K Cheung, BDS, PhD (1) · Negin Matini, DMD (1) · Reza Tabrizi, DMD (1) · Touba Karagah, DMD (1) · William N Williams, Ph.D (1)
R01DE010437 (1)