Stem cell-based therapies versus conventional bone grafting for alveolar cleft repair: a systematic review and meta-analysis
In brief
Stem cell therapy has no established advantage over bone grafting for cleft repair
Across 20 studies involving 437 people, evidence did not establish that stem cell therapy improves bone fill or repair success over iliac crest bone grafting. The only eligible randomized trial favored bone grafting by 44 percentage points in bone fill at six months, while other results varied widely. Very low certainty leaves the comparison unresolved and calls for stronger trials.
- Journal
- International journal of oral and maxillofacial surgery (Q1)
- Published
- 6 November 2026
- Study design
- Systematic review / meta-analysis of RCTs
- Evidence level
- Level 1, High (CEBM 1a)
- Authors
- Z Zayed, M Mudalal
- PMID
- 42995064
- DOI
- 10.1016/j.ijom.2026.10.010
Why clinicians should know about it
- Picked for Plastic and Reconstructive Surgery (top studies of the week, 8 November 2026): Comparative evidence for secondary alveolar cleft repair
Abstract
This systematic review and meta-analysis was performed to compare stem cell-based therapies with autologous bone grafting for secondary alveolar cleft repair. Databases and registries were searched through September 2025, and citation chasing was conducted. Eligible studies were randomized controlled trials (RCTs) and non-randomized comparative studies. In addition, case series (≥10 participants) were summarized narratively. The primary outcome was the percentage bone fill on cone-beam computed tomography (CBCT) or computed tomography (12-month preferred, 6-month fallback). Risk of bias was assessed using the Cochrane RoB 2 tool (RCTs), ROBINS-I (non-randomized studies), and JBI checklist (case series). Random-effects meta-analyses were performed when two or more studies reported comparable data; outcomes with I2 >90% were synthesized narratively. Twenty studies (six RCTs, 11 non-randomized studies, three case series) with 437 participants were included. The single eligible RCT showed a mean difference (MD) in percentage bone fill of -44% points (95% confidence interval (CI) -57 to -31) at 6 months, favouring iliac crest bone graft (ICBG). Including non-randomized studies, bone fill differences ranged from -44 to +9% points (I2 = 97%), precluding pooling. There was no significant difference in Bergland success (risk ratio 1.15, 95% CI 0.72-1.84; I2 = 43%) or bone volume (MD -1.72 mm3, 95% CI -419 to 416 mm3) between stem cell therapy and ICBG. The GRADE certainty of the evidence was very low for all outcomes. Current evidence does not establish a benefit of stem cell therapy over ICBG. Adequately powered, pre-registered RCTs reporting 12-month CBCT bone fill, Bergland success, and patient-centred outcomes are needed.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.