Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting Using Two Surgical Strategies: Stem Cells and Autogenous Iliac Crest Bone (Pain Evaluation in Children Undergoing Alveolar Grafting: Stem Cells vs. Iliac Crest Bone)

Summary

Study Objective The objective of this study was to evaluate and compare postoperative pain and hospital costs in pediatric patients with cleft lip and palate undergoing alveolar bone grafting surgery. The study compared a new tissue engineering approach against the traditional surgical technique. Background and Strategies To correct the bone defect in the upper jaw (alveolus), the standard treatment involves harvesting bone from the patient's hip (iliac crest). Although highly effective, this traditional method requires a second surgical site, which often leads to significant pain and complications at the donor site. To eliminate donor-site pain and morbidity, researchers evaluated an alternative approach using Stem Cells from Human Exfoliated Deciduous Teeth (SHED), which are naturally shed by children in this age group. These stem cells were combined with a collagen-hydroxyapatite scaffold (a supportive biomaterial sponge) to fill the bone defect, completely avoiding the need to harvest bone from the hip. Study Design A randomized controlled clinical trial was conducted with 20 pediatric patients aged 7 to 12 years with unilateral cleft lip and palate. Participants were randomly assigned into two equal groups: Group 1 (Control): Received the conventional autogenous bone graft harvested from the iliac crest. Group 2 (Experimental): Received the bioengineered graft combining SHED and the scaffold biomaterial. The researchers monitored the intensity and duration of pain in the Post-Anesthesia Care Unit (PACU) and the hospital ward. They also measured the consumption of simple analgesics and opioids (such as morphine and codeine) needed for pain relief, monitored postoperative complications, and performed an economic projection of medication expenditures.

Conditions

• Clift Lip
• Cleft Palate
• Alveolar Bone Loss
• Postoperative Pain

Interventions

PROCEDURE

Autogenous Iliac Crest Bone Grafting

A standard secondary alveolar bone grafting (SABG) procedure. Under general anesthesia, an autogenous corticocancellous bone graft is surgically harvested from the patient's anterior iliac crest. Concurrently, the maxillary cleft site is prepared by elevating the mucoperiosteal flaps. The harvested bone graft is then packed into the alveolar defect to bridge the cleft and provide structural support for canine eruption and dental arch continuity. The donor and recipient sites are subsequently sutured.

PROCEDURE

Bioengineered Alveolar Grafting (SHED + Scaffold)

An advanced tissue-engineering alternative to standard bone harvesting. The intervention utilizes Mesenchymal Stem Cells from Human Exfoliated Deciduous Teeth (SHED), which are isolated, expanded in vitro, and seeded onto a commercial, biocompatible collagen-hydroxyapatite scaffold biomaterial. Under general anesthesia, the maxillary cleft site is prepared via routine flap reflection, and the bioengineered construct (SHED + scaffold) is adapted and packed directly into the alveolar bone defect, completely avoiding any secondary donor-site surgery.

Sponsors & Collaborators

• Hospital Sirio-Libanes

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

7 Years

Max Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-03-31

Primary Completion

2017-03-31

Completion

2017-12-31

Countries

• Brazil

Study Locations