Earlier studies on cleft lip/palate and craniofacial conditions, sorted by publication date. Updated monthly from the research page.
📚 Archive: here you'll find earlier publications, sorted by date (newest first). ← Back to current research
Archive · Source: PubMed / NCBI
Earlier publications, sorted by date
SurgeryAI-generated, not professionally reviewed2025-08
TOPS Trial: What the Largest Cleft Palate RCT Tells Us About Surgical Timing
Fell M, Phippen G, van Eeden S, Swan MC, Carlin JB et al.
Cleft Palate Craniofac J. 2025;62(8):1436-1442
🔍After 5 years, no clinically relevant speech difference was found between surgery at 6 versus 12 months of age.
📋 For Parents & Patients
The TOPS trial compared palate closure at 6 versus 12 months. After 5 years, speech differences were measurable but clinically modest. Conclusion: both timings are acceptable; surgical quality matters more than the precise age of operation.
Study design: Perspective article reviewing a randomised controlled trial (RCT)
Limitation: This article is a commentary on the TOPS trial, not a new original study; detailed results derive from the original 2023 publication.
Clinical relevance: Both surgical timings (6 or 12 months) are medically defensible; surgical quality matters more than the exact timing.
The Timing of Primary Surgery (TOPS) trial was published August 2023 in the New England Journal of Medicine. This perspective article reviews the design and analysis of the trial, which compared palate closure at 6 months versus 12 months of age. After 5 years, speech differences were measurable but clinically modest.
Speech TherapyAI-generated, not professionally reviewed2025-08
Which Surgical Technique Best Improves Speech? Systematic Review 2025
Inchingolo AD, Inchingolo AM, Di Palma G et al.
Bioengineering. 2025;12(8):877 (Open Access)
🔍Early hard palate closure improves consonant articulation – but no single protocol is superior on all measures.
📋 For Parents & Patients
This systematic review (2014-2024) shows that early hard palate closure tends to improve consonant articulation. However, surgical technique and consistent speech therapy also substantially influence outcomes. No single universally superior protocol exists.
Study design: Systematic review (2014-2024)
Limitation: Substantial heterogeneity among included studies; no single protocol showed consistent superiority.
Clinical relevance: Early hard-palate closure appears to favour consonant articulation, but technique alone is not decisive – speech therapy follow-up remains central.
This systematic review (2014-2024) investigates how different surgical techniques influence speech outcomes in children with cleft palate. Early closure of the hard palate was linked to improved consonant articulation. However, surgical technique and subsequent speech therapy substantially modulate these outcomes. No single protocol showed uniform superiority.
SurgeryAI-generated, not professionally reviewed2024-05
Oslo vs. Delayed Palate Protocol: 4,800 Patients, No Clear Winner
Nollet PJPM, Kalaykova S, Kuijpers-Jagtman AM et al.
Int J Oral Maxillofac Surg. 2024;53(9):789-801
🔍Oslo protocol = better speech at age 5; delayed closure = better midfacial growth at age 12 – no overall winner.
📋 For Parents & Patients
This review of 4,831 patients compared the Oslo protocol with delayed closure. Oslo showed better speech at 5 years; delayed closure showed better facial bone growth at 12 years. The choice should be made individually at a specialist centre.
Study design: Systematic review & meta-analysis (n = 4831 patients)
Limitation: Included studies varied in quality; direct head-to-head comparisons between protocols were rare.
Clinical relevance: Choice of surgical protocol involves a trade-off between earlier speech outcomes (Oslo) and better midfacial growth (DHPCP) – no protocol is superior in every respect.
Systematic review and meta-analysis comparing the Oslo protocol and delayed hard palate closure protocols in 4,831 UCLP patients. Oslo protocol showed favourable speech outcomes at 5 years; DHPCP showed better midfacial growth at 12 years. No overall superior protocol was identified.
OrthodonticsAI-generated, not professionally reviewed2025-11
SARPE in Cleft and Craniofacial Patients: Current Indications and Outcomes 2025
Hu AC, Tolley PD, Ryan IA, Han NA, Swanson JW, Taylor JA et al.
Cleft Palate Craniofac J. 2025 (epub)
🔍SARPE can be used safely even in complex craniofacial syndromes, enabling effective upper jaw expansion.
📋 For Parents & Patients
Teenagers and adults with cleft lip and palate often develop a too-narrow upper jaw. SARPE corrects this when orthodontics alone is no longer sufficient. This study shows SARPE can be used safely in complex craniofacial syndromes -- often as preparation for jaw repositioning surgery.
Study design: Retrospective outcome study
Limitation: Patient group includes several diagnoses (clefts, craniosynostosis and others); results are not broken down by specific diagnosis.
Clinical relevance: Supports SARPE as an option for transverse maxillary narrowing in craniofacial conditions.
SARPE (surgically assisted rapid palatal expansion) is performed to address transverse maxillary hypoplasia in patients with cleft and craniofacial diagnoses. This study analyses outcomes in patients with cleft lip and palate, craniosynostosis, and other craniofacial diagnoses undergoing SARPE.
SurgeryAI-generated, not professionally reviewed2025-04
Three Protocols, 6,463 Patients: Which Approach for Cleft Palate Wins -- Major Study 2025
van Roey VL, Versnel SL, Heliovaara A et al. (Erasmus MC Rotterdam)
Int J Oral Maxillofac Surg. 2025;54(11):1043-1070
🔍OSPP and Oslo have fewer palatal fistulas than DHPCP but higher rates of hypernasality (VPI) – no protocol wins on all measures.
📋 For Parents & Patients
This large review of 6,463 patients from 162 studies compared three surgical strategies. Result: Oslo protocol and one-stage closure showed fewer palatal fistulas but higher rates of hypernasality (VPI). Delayed closure had less VPI but more fistulas. No protocol was superior on all counts, reinforcing the case for individualized decision-making at specialist centres.
Limitation: Large number of included studies with varying methodology, limiting comparability between the three protocols.
Clinical relevance: One-stage palatoplasty (OSPP) and the Oslo protocol appear overall favourable compared with delayed hard-palate closure (DHPCP).
This systematic review and meta-analysis compared three UCLP treatment protocols: one-stage palatoplasty (OSPP), Oslo protocol, and delayed hard palate closure (DHPCP) in 6,463 patients across 162 studies. VPI incidence was significantly higher in Oslo (24%) versus DHPCP (9%), with OSPP intermediate (14%). Oronasal fistula rates were lower for OSPP and Oslo. Overall, OSPP and Oslo are favoured over DHPCP.
Speech TherapyAI-generated, not professionally reviewed2026-02
Hypernasality After Palate Surgery: Which Secondary Procedure Works Best? 1,774 Patients
Fasahat A, Omid M, Khanlar F, Maracy M (Isfahan Cleft Care Team)
Cleft Palate Craniofac J. 2026 (epub)
🔍The Furlow technique achieved the best hypernasality improvement rate (85%), but is associated with higher sleep apnea risk than pharyngeal flap.
📋 For Parents & Patients
When a nasal sound persists after palate surgery (velopharyngeal insufficiency, VPI), a second operation may help. This review of 1,774 patients shows that the Furlow technique achieved the best improvement rates (85%), followed by pharyngeal flap (85%). However, pharyngeal flap carries a higher risk of sleep apnea. Method choice always depends on the individual situation.
Limitation: Inconsistent definitions of success across included studies complicate direct comparison of techniques.
Clinical relevance: Furlow Z-plasty and pharyngeal flap show the highest improvement rates for hypernasality, though pharyngeal flap carries greater sleep-apnoea risk – relevant to technique choice.
Systematic review and meta-analysis of 1,774 VPI patients across 31 studies comparing five surgical techniques: pharyngeal flap, sphincter pharyngoplasty, Furlow Z-plasty, buccal flap, and buccinator flap. Furlow palatoplasty showed the highest average improvement rate (85%), followed by pharyngeal flap (84.5%). Pharyngeal flap was associated with higher obstructive sleep apnea rates.
When a nasal sound persists after palate surgery, a pharyngeal flap is sometimes used. This study shows the pharyngeal flap increases sleep apnea risk 2.45-fold. Palatal lengthening procedures carry significantly lower sleep apnea risk. For children with existing snoring or sleep apnea, the pharyngeal flap should not be the first choice.
Limitation: Only 4 included studies; a relatively small overall evidence base for a meta-analysis.
Clinical relevance: The increased sleep-apnoea risk after pharyngeal flap surgery should inform counselling and postoperative monitoring.
Systematic review and meta-analysis comparing the risk of obstructive sleep apnea (OSA) following pharyngeal flap versus non-pharyngeal flap VPI procedures (751 subjects, 4 studies). Pharyngeal flap use was associated with a significantly greater risk of OSA (pooled risk ratio 2.45). Palatal lengthening procedures had a significantly lower OSA risk.
SurgeryAI-generated, not professionally reviewed2025-07
Correct the Nose at the Same Time? Children's Self-Perception Favours Primary Rhinoplasty
Ryan IA, Ng JJ, Kim J, Tolley PD, Jackson OA, Bartlett SP, Taylor JA, Swanson JW. (CHOP Philadelphia)
Cleft Palate Craniofac J. 2025;63(7):1885-1894
🔍Children with primary rhinoplasty rated their nasal appearance at age 10 significantly better (CLEFT-Q score: 75 vs. 57).
📋 For Parents & Patients
Should the nose be corrected at the same time as the cleft lip repair? This study of 109 school-age children shows that those who had their nose corrected during the first operation scored their nasal appearance at age 10 significantly higher (CLEFT-Q score 75 vs 57). They also needed fewer secondary operations later.
Study design: Retrospective comparative study (patient-reported outcomes) (n = 109 patients)
Limitation: Retrospective and single-centre; who received primary rhinoplasty was not randomised.
Clinical relevance: Supports considering nasal correction already at primary lip repair to reduce the need for later secondary surgery.
Retrospective study of 109 patients with cleft lip comparing patient-reported outcomes (CLEFT-Q) in those who did or did not undergo primary rhinoplasty at time of lip repair. Primary rhinoplasty was associated with improved self-perception of nasal appearance in school-aged children (CLEFT-Q nose score 75 vs 57). Patients without primary rhinoplasty were significantly more likely to undergo secondary rhinoplasty later.
SurgeryAI-generated, not professionally reviewed2025-06
Correcting the Nose at Cleft Lip Repair: Large Meta-Analysis Confirms Benefit -- 65 Studies
Alanazi F, Alonazi M, Hazazi MT, AlQahtani SM, Alenezi M
J Craniofac Surg. 2025;37(3-4):450-458
🔍Primary rhinoplasty is nearly twice as effective as lip surgery alone (RR 1.87); only 14% of unilateral cases needed a second nasal operation.
📋 For Parents & Patients
This large meta-analysis (65 studies, 4,337 cases screened) shows that simultaneous nasal correction at cleft lip repair is nearly twice as effective as lip surgery alone. A good result is achieved in 73.6% of unilateral cases and 88% of bilateral cases. Only 14% of unilateral cases later need another nasal operation.
Limitation: Wide range of included surgical techniques and follow-up periods across studies.
Clinical relevance: Confirms, with a large evidence base, the benefit of primary rhinoplasty over lip repair alone.
Systematic review and meta-analysis of 65 studies (4,337 records screened) on primary rhinoplasty effectiveness in cleft lip. Primary rhinoplasty was significantly more effective than cleft repair alone (RR 1.87). Success rate 73.6% for unilateral, 88% for bilateral cases. Only 14% required additional surgeries for unilateral deformities.
Speech TherapyAI-generated, not professionally reviewed2024-10
How Reliably Is Speech Measured in Children With Cleft Palate? Swedish Registry, 121 Ten-Year-Olds
Klinto K, Schaar Johansson M, Andersson M et al. (Lund University, Schweden)
Cleft Palate Craniofac J. 2024;62(12):2167-2174
🔍Measurement of consonant articulation showed excellent reproducibility between different raters (ICC 0.93).
📋 For Parents & Patients
For treatment results to be compared across clinics, speech tests must be reliable. This Swedish study tests the speech registry for children with cleft palate in 121 ten-year-olds: measurement of consonant articulation was excellently reproducible (ICC 0.93). This shows that standardised speech assessments in national registers are reliable enough for quality comparisons between clinics.
Study design: Reliability study (registry data) (n = 121 children)
Limitation: Only one national registry (Sweden) was studied; generalisability to other countries/registries was not tested.
Clinical relevance: Confirms that standardised speech metrics can be reliably used in quality registries – important for comparisons across centres.
Reliability study of speech variables in the Swedish quality registry for cleft lip and palate. 121 ten-year-olds with CLP assessed by 6 independent raters. Excellent reliability for percentage of consonants correct (ICC 0.93) and non-oral errors (ICC 0.80). Findings support use of standardised speech assessment in clinical quality registers.
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