Cleft Lip and PalatePhase 4NCT04234971
Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate
A Phase 4 study testing Intervention group (DBM/BMP) in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Intervention group (DBM/BMP)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 1 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patient with CLP(unilateral or bilateral)
- Radiographically evident open bone defect of the alveolus
- Dentition evaluated by orthodontist and cleared for ABG surgery
Who cannot join
- Patients without CLP
- Previous failed repair of alveolar cleft
- Patients who have previously undergone successful ABG
- Patients without an alveolar defect
- Patients whose parents refuse to consent to randomization
- Patients who have a syndromic CLP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tien Do, DO contact
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Matthew Greives, MD, 713-500-7275, Matthew.R.Greives@uth.tmc.edu
Tien Do, DO, Tien.Do@uth.tmc.edu
About this study
Official title: Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.
- Conditions
- Cleft Lip and Palate
- Being tested
- Intervention group (DBM/BMP), Control group(autologous ICBG)
- Keywords
- alveolar bone graft, Bone Morphogenic Protein, Demineralized Bone Matrix, cleft lip
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group (DBM/BMP)Drug
All patients will undergo a standard procedure for exposure of the cleft alveolar defect and closure of all oronasal fistulae. After induction of general anesthesia, the patient will be intubated with an oral ray tube and prepped and draped in sterile fashion. Pre-operative antibiotics will be given to cover oral flora (i.e. Unasyn or clindamycin if penicillin allergy exists). The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed. For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN). The sponge and DBM will then be packed into the defect to completely fill the bony space (FIGURE 3). The anterior mucosa will then be closed.
Control group(autologous ICBG)Drug
The patient will be induced with anesthesia, prepped, and draped. The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed.In the control group, the ICBG will be harvested percutaneously using the Accumed bone graft harvesting system. Briefly, an incision will be made in iliac crest and drill bit inserted. Multiple passes of the drill be used to harvest as much autograft bone as possible from the cancellous region of the iliac crest.Following harvest, fibrin glue will be instilled for hemostasis and a Ropivicaine On-Q pain pump inserted for post-operative pain control. The harvest bone graft will be packed into the alveolar defect in a similar fashion and the mucosa closed anteriorly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (DBM/BMP) | Experimental | Patient undergoes Alveolar bone graft with DBM/BMP Receives: Drug: Intervention group (DBM/BMP) |
| Control group(autologous ICBG) | Active comparator | Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft. Receives: Drug: Control group(autologous ICBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health system costs per successful bone graft.
Health system costs will be reported as the total sum of all costs including incremental surgeon time costs, hospital costs, revision costs, and additional outpatient costs for clinic or ER visits. Bone graft success be defined as no need for a repeat bone graft, as well as by assessment by blinded orthodontist evaluations of the Post op Cone beam computed tomography(CBCT).
Measured: One year post graft
Secondary outcomes (11)
Graft Success
Graft success as indicated by number of patients that did not have exposure of graft as assessed by post op CBCT
Measured: 3 months post graft
Infection
Graft success as indicated by number of patients that had no graft infection as assessed by post op CBCT
Measured: 3 months post graft
Fistula Recurrence
Graft success as indicated by number of patients that had no recurrence of oronasal fistula as assessed by post op CBCT
Measured: 3 months post graft
Rate of Revision ABG
Graft success as indicated by number of patients that had no no need for repeat bone graft as assessed by post op CBCT
Measured: 3 months post graft
Operative Time
Total time for operation
Measured: 1 day
Anesthesia Time
total time of anesthesia
Measured: 1 day
Post Operative Pain Scores
Change in pain as assessed by the numeric Rating Scale(NRS) for pain. The NRS total score ranges form 0(no hurt) to 10(hurts worst)
Measured: 1 week post operatively
Pain Medication Usage
Total dose of post-operative narcotics used
Measured: 1 week post operatively
Post Op Fever
Number of patients with the post operative complication fever
Measured: 3 months
Drainage from Fistula
Number of patients with the post operative complication drainage from donor site or alveolar site
Measured: 3 months
Post Op ER Visits
Number of patients with the post operative complication ER or primary care visits
Measured: 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2020
- Study start14 Jun 2021
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Greives, The University of Texas Health Science Center, Houston
- Investigators
- Matthew Greives, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04234971
- Sponsor's protocol ID
- HSC-MS-19-1027
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2020
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04234971
- Acronym / sponsor ID
- HSC-MS-19-1027
- Conditions
- Cleft Lip and Palate
- Keywords
- alveolar bone graft, Bone Morphogenic Protein, Demineralized Bone Matrix, cleft lip
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 21 Jan 2020 (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.
The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)/Demineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM/BMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (DBM/BMP) | Experimental | Drug: Intervention group (DBM/BMP)Patient undergoes Alveolar bone graft with DBM/BMP |
| Control group(autologous ICBG) | Active comparator | Drug: Control group(autologous ICBG)Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Patient with CLP(unilateral or bilateral)
- Radiographically evident open bone defect of the alveolus
- Dentition evaluated by orthodontist and cleared for ABG surgery
Key exclusion criteria (6 listed)
- Patients without CLP
- Previous failed repair of alveolar cleft
- Patients who have previously undergone successful ABG
- Patients without an alveolar defect
- Patients whose parents refuse to consent to randomization
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 |
|---|---|---|
| Intervention group (DBM/BMP)All patients will undergo a standard procedure for exposure of the cleft alveolar defect and closure of all oronasal fistulae. After induction of general anesthesia, the patient will be intubated with an oral ray tube and prepped and draped in sterile fashion. Pre-operative antibiotics will be given to cover oral flora (i.e. Unasyn or clindamycin if penicillin allergy exists). The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed. For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN). The sponge and DBM will then be packed into the defect to completely fill the bony space (FIGURE 3). The anterior mucosa will then be closed. | Drug | Intervention group (DBM/BMP) |
| Control group(autologous ICBG)The patient will be induced with anesthesia, prepped, and draped. The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed.In the control group, the ICBG will be harvested percutaneously using the Accumed bone graft harvesting system. Briefly, an incision will be made in iliac crest and drill bit inserted. Multiple passes of the drill be used to harvest as much autograft bone as possible from the cancellous region of the iliac crest.Following harvest, fibrin glue will be instilled for hemostasis and a Ropivicaine On-Q pain pump inserted for post-operative pain control. The harvest bone graft will be packed into the alveolar defect in a similar fashion and the mucosa closed anteriorly. | Drug | Control group(autologous ICBG) |
Primary outcome
Health system costs per successful bone graft.
Time frame: One year post graft
Health system costs will be reported as the total sum of all costs including incremental surgeon time costs, hospital costs, revision costs, and additional outpatient costs for clinic or ER visits. Bone graft success be defined as no need for a repeat bone graft, as well as by assessment by blinded orthodontist evaluations of the Post op Cone beam computed tomography(CBCT).
11 secondary outcomes
Graft Success
Time frame: 3 months post graft
Infection
Time frame: 3 months post graft
Fistula Recurrence
Time frame: 3 months post graft
Rate of Revision ABG
Time frame: 3 months post graft
Operative Time
Time frame: 1 day
Anesthesia Time
Time frame: 1 day
Post Operative Pain Scores
Time frame: 1 week post operatively
Pain Medication Usage
Time frame: 1 week post operatively
Post Op Fever
Time frame: 3 months
Drainage from Fistula
Time frame: 3 months
Post Op ER Visits
Time frame: 3 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Tien Do, DO contact
Matthew Greives, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intervention group (DBM/BMP) in people with Cleft Lip and Palate, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 Feb 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 United States. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matthew Greives, MD ((713) 500-7275, Matthew.R.Greives@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health system costs per successful bone graft. (time frame: One year post graft). 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 19 Feb 2026.