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A comparison of human amnion protected graft with unprotected iliac cancellous bone graft in bilateral cleft alveolus patients - randomised double blind study

To evaluate the bone induction effect of an amnion membrane protected graft compared with an unprotected autogeneous bone graft in the repair of cleft alveolus in bilateral cleft patients- A prospective randomized double blinded study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/12/047971
Enrollment
20
Registered
2022-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Amnion membrane with bone graft: total duration is 1 year follow up after intervention. preoperative intraoperative 1 year follow up postoperatively Control Intervention1: Autogenous

Sponsors

Dr meenakshi c kothari
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. nonsyndromic bilateral cleft patients with age ranging from 7-13 years. 2.Cone-beam computed tomography (CBCT) performed before SABG. 3. Bilateral alveolar cleft with or without cleft palate

Exclusion criteria

Exclusion criteria: 1. Previous alveolar bone graft 2. Application of orthodontic treatment or gingivoperiosteoplasty before SABG 3. Any severe systemic disease such as rickets or osteoporosis

Design outcomes

Primary

MeasureTime frame
primary outcome: 1. bone tissue formed using bergland and chelsa scale 2. changes in bone density, volume and height secondary outcome: eruption of permanent canineTimepoint: THE OUTCOMES TO BE REGULATED PREOPERATIVELY AND 1 YEAR POSTOPERATIVELY—

Secondary

MeasureTime frame
eruption of permanent canineTimepoint: preoperatively and postoperative one year—

Countries

India

Contacts

Public ContactDr CHAITANYA KOTHARI

HKEs SN INSTITUTE OF DENTAL SCIENCES AND RESEARCH

satpat71@gmail.com09448124464

Outcome results

None listed

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