Reconstruction of palatal cleft using 3D printer

Investigation of the effect of a 3D printed biocompatible composite scaffold customized for the patient with the use of buccal fat pad micrograft on regeneration of bone defects in the patients with palatal and alveolar bone cleft

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20191002044949N1

Enrollment

Registered

2022-01-11

Start date

2021-04-20

Completion date

Unknown

Last updated

2022-02-07

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

Conditions

Maxillary alveolar cleft.

Interventions

Intervention 1: Intervention group: Gelatin (5-20 wt%)/ alginate (1-4 wt%)/ allograft (10-40 wt%) in combination with buccal fat pad micrograft. Gelatin with medical grade is purchased from Nitta Gela

Eligibility

Sex/Gender

All

Age

10 Years to No maximum

Inclusion criteria

Inclusion criteria: Patient with alveolar or palatal cleft Defect size more than 2 cm3 soft tissue deficiency is not seen maxillary sinus is not involved Dental dehiscence or fenestration is not seen

Exclusion criteria

Exclusion criteria: autoimmune or metabolic or systemic diseases peripheral vascular diseases marble bone disease or osteoporosis smoking or alcohol consuption conditions which compromise wound healing process being in breastfeeding or pregnancy

Design outcomes

Primary

Measure	Time frame
Height, width and length of the ridge at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan.;New formed bone density at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Radio morphometry using CBCT scan.;Native bone and scaffold contact at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan.;The rate of new bone formation at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;The rate of fibrosis or necrosis if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;Foreign body reaction if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;The rate of scaffold remnants if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.	—

Measure

Time frame

Height, width and length of the ridge at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan.;New formed bone density at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Radio morphometry using CBCT scan.;Native bone and scaffold contact at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan.;The rate of new bone formation at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;The rate of fibrosis or necrosis if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;Foreign body reaction if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.;The rate of scaffold remnants if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshid Bastami

Shahid Beheshti University of Medical Sciences

farshidbst@gmail.com+98 21 2217 5350

Outcome results

None listed

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