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TREPHINE VS CLAMSHELL TECHNIQUES FOR HARVESTING ILIAC CREST BONE GRAFT IN ALVEOLAR CLEFT PATIENTS: A RANDOMIZED CONTROLLED TRIAL

TREPHINE VERSUS CLAMSHELL TECHNIQUES FOR HARVESTING ILIAC CREST BONE GRAFT IN ALVEOLAR CLEFT PATIENTS: A RANDOMIZED CONTROLLED TRIAL

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251014009
Enrollment
32
Registered
2025-10-14
Start date
2025-06-28
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

alveolar cleft iliac crest bone grafting Alveolar cleft Cleft Lip Cleft Palate Bone Transplantation Ilium Iliac crest bone graft Pain, Postoperative Randomized Controlled Trial

Interventions

Clamshell Technique: An open surgical approach is performed at the anterior iliac crest. After a skin incision, soft tissue dissection exposes the iliac bone. A greenstick fracture of the outer cortic
Active Comparator Procedure/Surgery,Active Comparator Procedure/Surgery
iliac crest bone graft using clamshell technique,iliac crest bone graft using Trephine bur

Sponsors

Faculty of dentistry Khon Kaen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Alveolar cleft Patients who is going to receive unilateral alveolar bone graft 2. Age 8 years to 18 years old. 3. ASA class I or II according to American Society of Anesthesiologists classification, 2023 (53) 4. Iliac crest cancellous bone is selected as a source of bone graft material

Exclusion criteria

Exclusion criteria: 1. History of previous iliac crest bone harvesting at the selected donor site 2. History of trauma at selected donor site 3. Patients who have systemic bone disease. 4. Patients who have local bone abnormality at pelvic area 5. Patients with any communication problem e.g. autism

Design outcomes

Primary

MeasureTime frame
Donor site pain score measured by Numeric Rating Scale (NRS) within 42 hours postoperatively At 1, 6, 12, 18, 24, 30, 36, and 42 hours postoperatively numerical rating scale

Secondary

MeasureTime frame
Total Morphine Consumption 0 to 42 hours postoperatively Cumulative dose recorded in milligrams from anesthesia records and postoperative nursing charts,Total Paracetamol Consumption 0 to 42 hours postoperatively Cumulative dose recorded in milligrams from medical administration records,Operative Time Intraoperative Duration from skin incision to skin closure, recorded by the surgical team in minutes,Time to First Ambulation Postoperative period Time recorded in hours from end of surgery until first successful ambulation, documented by nursing staff,Postoperative Complications Monitored continuously from 0 to 7 days postoperatively or until discharge Clinical assessment and documentation of any donor-site complications (e.g., infection, hematoma, gait disturbance) classified as minor or major

Countries

Thailand

Contacts

Public ContactBoonsita Wuttirak

Faculty of Dentistry, Khon Kaen University, Khon Kaen

boonsita.wt@gmail.com0855553344

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026