Description of Pain in Pediatric Patients With Cleft Lip and Palate Undergoing Alveolar Grafting … (NCT07734974) | Clinical Trial Compass
CompletedPhase 1/2
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)
Brazil20 participantsStarted 2015-03
Plain-language 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.
Who can participate
Age range
7 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Postoperative Pain Intensity
Timeframe: Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).