Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT04234971

Conditions

Cleft Lip and Palate

Eligibility Criteria

Sex: All

Age: 6 - 15

Healthy Volunteers: Not accepted

Interventions

Intervention group (DBM/BMP)

Control group(autologous ICBG)

Study Details

Brief 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 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

Study ID

NCT04234971

Start date

Jun 14, 2021

Status verified date

Feb, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 15

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient with CLP(unilateral or bilateral)
  • Radiographically evident open bone defect of the alveolus
  • Dentition evaluated by orthodontist and cleared for ABG surgery

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Intervention group (DBM/BMP)

Patient undergoes Alveolar bone graft with DBM/BMP

active comparator: Control group(autologous ICBG)

Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.

Interventions

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.

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.

Primary outcome measure

  • Health system costs per successful bone graft. [ Time Frame: One year post graft ]

Central Contacts and Locations

Central contacts

Matthew Greives, MD

(713) 500-7275Matthew.R.Greives@uth.tmc.edu

Tien Do, DO

Tien.Do@uth.tmc.edu

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Matthew Greives, MD

713-500-7275Matthew.R.Greives@uth.tmc.edu

Tien Do, DO

Tien.Do@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Feb 19, 2026

Last verified

Feb, 2026

Keywords

  • alveolar bone graft
  • Bone Morphogenic Protein
  • Demineralized Bone Matrix
  • cleft lip

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-02-19.