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)

NCT07734974 | Completed Phase 1

• 1 other identifier: 1.197.470
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cleft Lip and Palate; Tissue Engineering; Stem Cells; Alveolar Bone Grafting; Postoperative Pain; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Intensity

  Postoperative pain will be assessed using a validated visual analog scale (VAS) or faces pain scale appropriate for pediatric patients. Pain levels will be recorded at specific resting and moving intervals to compare the donor-site morbidity of the traditional iliac crest graft against the bioengineered scaffold.

  Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).

Study Arms (2)

Control Group: Autogenous Iliac Crest Bone Graft

ACTIVE COMPARATOR

Autogenous Iliac Crest Bone Graft: Pediatric patients with unilateral cleft lip and palate assigned to receive the standard-of-care surgical intervention. This consists of secondary alveolar bone grafting using an autogenous bone graft harvested from the patient's anterior iliac crest (hip bone) to reconstruct the maxillary alveolar cleft defect under general anesthesia.

Procedure: Autogenous Iliac Crest Bone Grafting

Experimental Group: Bioengineered SHED Graft

EXPERIMENTAL

Bioengineered SHED Graft: Pediatric patients with unilateral cleft lip and palate assigned to receive the tissue-engineered intervention. This consists of secondary alveolar bone grafting using Mesenchymal Stem Cells from Human Exfoliated Deciduous Teeth (SHED) seeded onto a commercial collagen-hydroxyapatite scaffold biomaterial to reconstruct the maxillary alveolar cleft defect, completely eliminating the need for a donor-site harvesting surgery.

Procedure: Bioengineered Alveolar Grafting (SHED + Scaffold)

Interventions

Autogenous Iliac Crest Bone Grafting PROCEDURE

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.

Also known as: Secondary Alveolar Bone Grafting (SABG), Iliac Crest Bone Graft (ICBG), Autologous Iliac Crest Bone Graft

Control Group: Autogenous Iliac Crest Bone Graft

Bioengineered Alveolar Grafting (SHED + Scaffold) PROCEDURE

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.

Also known as: Tissue-Engineered Alveolar Bone Graft, Stem Cells from Human Exfoliated Deciduous Teeth Graft, SHED-seeded Collagen-Hydroxyapatite Scaffold

Experimental Group: Bioengineered SHED Graft

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients aged between 7 and 12 years old.
• Diagnosed with congenital unilateral cleft lip and palate.
• Presenting with a maxillary alveolar cleft defect requiring secondary alveolar bone grafting (SABG) intervention.
• Patient and legal guardians tracking dental development indicating the appropriate chronological/dental age for grafting (prior to canine eruption).
• Written informed consent provided by parents or legal guardians, and assent provided by the pediatric participant.

You may not qualify if:

• Patients with bilateral cleft lip and palate or complex syndromic craniofacial conditions.
• Previous history of secondary alveolar bone grafting failure at the same anatomical site.
• Systemic medical conditions that contraindicate general anesthesia or major oral surgery (e.g., uncontrolled bleeding disorders or severe systemic infections).
• History of bone metabolism disorders or compromised immune systems that could interfere with bone healing or scaffold integration.
• Inability or refusal of the family/patient to comply with follow-up appointments and postoperative clinical evaluations.

Sponsors & Collaborators

• Hospital Sirio-Libanes: lead

Study Sites (1)

Hospital Sírio-Libanês

São Paulo, São Paulo, 01308050, Brazil

Location

MeSH Terms

Conditions

Cleft Palate; Alveolar Bone Loss; Pain, Postoperative; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mouth Abnormalities; Mouth Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Bone Resorption; Bone Diseases; Periodontal Atrophy; Periodontal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Lip Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, controlled, parallel-group clinical trial with a 1:1 allocation ratio. A total of 20 pediatric patients aged 7 to 12 years with unilateral cleft lip and palate were randomly assigned to one of two concurrent treatment arms : Group 1 (Control Group, n = 10) received the traditional gold standard treatment consisting of an autogenous bone graft harvested from the anterior iliac crest. Group 2 (Experimental Group, n = 10) received a tissue-engineered graft consisting of mesenchymal stem cells from human exfoliated deciduous teeth (SHED) combined with a collagen-hydroxyapatite scaffold biomaterial. Participants remained in their assigned treatment group for the duration of the surgical intervention, immediate post-anesthesia recovery, and long-term follow-up phases to evaluate postoperative pain, opioid consumption, and clinical/economic outcomes.

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: July 29, 2026
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)