Clift LipPhase 1/2NCT07734974
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)
A Phase 1/2 study testing Autogenous Iliac Crest Bone Grafting and Bioengineered Alveolar Grafting (SHED + Scaffold) in people with Clift Lip and Cleft Palate, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Clift Lip, Cleft Palate, Alveolar Bone Loss
- What is being tested?
- Autogenous Iliac Crest Bone Grafting and Bioengineered Alveolar Grafting (SHED + Scaffold)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Dec 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Autogenous Iliac Crest Bone Grafting, Bioengineered Alveolar Grafting (SHED + Scaffold)
- Keywords
- Cleft Lip and Palate, Tissue Engineering, Stem Cells, Alveolar Bone Grafting, Postoperative Pain, Cost-Benefit Analysis
- Medical subject headings
- Cleft Palate, Alveolar Bone Loss, Pain, Postoperative, Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autogenous Iliac Crest Bone GraftingProcedure or surgery
Also called Secondary Alveolar Bone Grafting (SABG), Iliac Crest Bone Graft (ICBG), Autologous Iliac Crest Bone Graft
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.
Bioengineered Alveolar Grafting (SHED + Scaffold)Procedure or surgery
Also called Tissue-Engineered Alveolar Bone Graft, Stem Cells from Human Exfoliated Deciduous Teeth Graft, SHED-seeded Collagen-Hydroxyapatite 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Bioengineered Alveolar Grafting (SHED + Scaffold) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startMar 2015
- Primary completionMar 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clift LipStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734974
- Sponsor's protocol ID
- 1.197.470
- Status last verified
- Jun 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07734974
- Acronym / sponsor ID
- 1.197.470
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control Group: Autogenous Iliac Crest Bone Graft | Active comparator | Procedure: Autogenous Iliac Crest Bone GraftingAutogenous 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. |
| Experimental Group: Bioengineered SHED Graft | Experimental | Procedure: Bioengineered Alveolar Grafting (SHED + Scaffold)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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autogenous Iliac Crest Bone GraftingAlso: Secondary Alveolar Bone Grafting (SABG), Iliac Crest Bone Graft (ICBG), Autologous Iliac Crest Bone GraftA 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 or surgery | Control Group: Autogenous Iliac Crest Bone Graft |
| Bioengineered Alveolar Grafting (SHED + Scaffold)Also: Tissue-Engineered Alveolar Bone Graft, Stem Cells from Human Exfoliated Deciduous Teeth Graft, SHED-seeded Collagen-Hydroxyapatite ScaffoldAn 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. | Procedure or surgery | Experimental Group: Bioengineered SHED Graft |
Primary outcome
Postoperative Pain Intensity
Time frame: Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autogenous Iliac Crest Bone Grafting and Bioengineered Alveolar Grafting (SHED + Scaffold) in people with Clift Lip and Cleft Palate, run by Hospital Sirio-Libanes at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: Up to 7 days post-surgery (specifically evaluated at 6 hours, 12 hours, 24 hours, 48 hours, and 7 days postoperatively).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.