Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique

Tertiary Alveolar Cleft Reconstruction Using Double Mandibular Cortical Bone Blocks Technique Versus Double Iliac Corticocancellous Bone Blocks Technique A Randomized Clinical Trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07612423

Enrollment

Registered

2026-05-28

Start date

2026-06-01

Completion date

2028-01-01

Last updated

2026-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alveolar Cleft Grafting

Brief summary

The current study aims to compare the double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between versus the double iliac corticocancellous bone blocks technique with iliac cancellous bone particles in between in the tertiary cleft grafting to find out which technique maintained better graft width, height, and volume with the least adverse effects after the healing period and hence would allow for restoration of the targeted function and esthetics and improve the cleft patients psychologically and hence improve their quality of life.

Interventions

PROCEDUREgrafting of the alveolar cleft

patients with unilateral alveolar cleft treated withthe double mandibular corticocancellous bone blocks technique with mandibular cancellous bone particles in between.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with unilateral alveolar cleft who missed the mixed dentition phase window. * patients with previously repaired cleft lip and palate. * patients with proper oral hygiene.

Exclusion criteria

* Immunocompromised patients. * patients with active periodontitis. * patients with inadequate oral hygiene.

Design outcomes

Primary

Measure	Time frame	Description
Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by CBCT analysis	6 months	Measurement of gained bone volume after 6 months of graft healing in cubic millimeter by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively. volume assessment will be by specialized software 3D Slicer

Secondary

Measure	Time frame	Description
Measurement of gained bone labio-palatal width and height in millimeter by CBCT analysis	6 months	Measurement of gained bone labio-palatal width and height in millimeter after 6 months of graft healing by comparison between CBCT scans that will be taken postoperatively, and after 6 months postoperatively by specialized software Atomica ai.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 27, 2026