Skip to content

A randomized controlled trial for the effect of monocortical mandibular bone grafting for reconstruction of unilateral alveolar cleft.

An assessor-blinded, randomized, 24-month, parallel-group, non-inferiority study to compare the efficacy of monocortical mandibular bone grafting versus cancellous iliac bone grafting in the reconstruction of unilateral alveolar cleft.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034227
Enrollment
Unknown
Registered
2020-06-29
Start date
2020-06-28
Completion date
Unknown
Last updated
2020-06-29

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

Conditions

Alveolar cleft

Interventions

experimental group:Computer aided monocortical mandibular bone grafting
control group:cancellous iliac bone grafting

Sponsors

Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
9 Years to 16 Years

Inclusion criteria

Inclusion criteria: 1. Patients with unilateral alveolar cleft; 2. Aged 9-16 years old; 3. Promary repair of cleft lip with/without palate has been completed; 4. Bone grafting is needed to repair the cleft of alveolar process; 5. Good oral hygiene habits and periodontal conditions; 6. Agree to participate in the test and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Syndromic CLP; 2. Patient with bilateral alveolar cleft; 3. Suffer from systemic diseases (hypertension, diabetes, autoimmune diseases, etc.); 4. Smoking and drinking; 5. The oral hygiene condition is poor, and the periodontal condition can not meet the operation requirements after periodontal treatment; 6. Alveolar bone grafting patients has failed; 7. Patient can not cooperate with follow-up after operation.

Design outcomes

Primary

MeasureTime frame
absorption rate of the bone grafts;

Secondary

MeasureTime frame
Operation time;Hospitalization period and expenses;Gingival recession;Patient satisfactory;

Countries

China

Contacts

Public ContactMing Cai

Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

zidanecm500@126.com+86 13918490900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 26, 2026