Long-term functional outcomes of primary cleft surgery

Success rate of mid-secondary alveolar cleft reconstruction using anterior iliac bone grafts: a retrospective study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN24136967

Enrollment

124

Registered

2022-03-30

Start date

1991-01-01

Completion date

Unknown

Last updated

2023-06-05

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

Conditions

Veau III and Veau IV cleft palate Surgery

Interventions

Alveolar repair through iliac bone graft took place as warranted at 8-11 years of age to accommodate canine eruption and development, along with premaxillary repositioning osteotomy of bilateral compl

Baxter AG, Vienna, Austria) was applied at times (not routinely) below the repaired nasal layer (Vicryl 5-0

Ethicon, Somerville, NJ, USA) and stabilized by adding fibrin sealant (Tisseel

Baxter). Bone marrow was aspirated from the iliac crest using a 50-mm Jamshidi needle (Handlex

Medax, Poggio Rusco, Italy). Cancellous bone was harvested through a medially based trap-door technique from the anterior iliac crest (Video) with the use of Champy 8 mm and 5 mm Bone Biopsy Instrumen

afterwards, was syringe-condensed into the alveolar cleft and manually molded. After suturing of oral mucosa (Vicryl 4/0), fibrin sealant was employed to affix the mucoperiosteal flaps onto the transp

First Aid Bandage Company, New London, CT, USA) was inserted and remained in place until hospital discharge (average, 2 days). At the donor site, a continuous anesthetic elastomeric pump (Baxter Inter

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All cleft patients receiving secondary alveolar bone grafts between 1991 and 2020 were reviewed

Exclusion criteria

Exclusion criteria: 1. Lost to follow-up 2. Incomplete files

Design outcomes

Primary

Measure	Time frame
Success rate of autogenous mid-secondary alveolar bone grafting assessed using patient charts from between 1990 and 2020. Criteria for success were: long-term preservation of alveolar bone stock, ability of spontaneous or orthodontic-guided eruption and periodontal health of permanent lateral incisors and canine teeth, absence of exposed root structures for teeth adjacent to clefts, absence of fistula and successful placement of osseointegrated implants as warranted. Failure of alveolar bone grafts was indicated by radiographically demonstrable total or near-total graft loss requiring reintervention.	—

Measure

Time frame

Success rate of autogenous mid-secondary alveolar bone grafting assessed using patient charts from between 1990 and 2020. Criteria for success were: long-term preservation of alveolar bone stock, ability of spontaneous or orthodontic-guided eruption and periodontal health of permanent lateral incisors and canine teeth, absence of exposed root structures for teeth adjacent to clefts, absence of fistula and successful placement of osseointegrated implants as warranted. Failure of alveolar bone grafts was indicated by radiographically demonstrable total or near-total graft loss requiring reintervention.

—

Secondary

Measure	Time frame
There were no secondary outcome measures	—

Countries

Belgium

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026