Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate

NCT04234971 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: HSC-MS-19-1027
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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).

  One year post graft

Secondary Outcomes (11)

• Graft Success

  3 months post graft

• Infection

  3 months post graft

• Fistula Recurrence

  3 months post graft

• Rate of Revision ABG

  3 months post graft

• Operative Time

  1 day

Study Arms (2)

Intervention group (DBM/BMP)

EXPERIMENTAL

Patient undergoes Alveolar bone graft with DBM/BMP

Drug: Intervention group (DBM/BMP)

Control group(autologous ICBG)

ACTIVE COMPARATOR

Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.

Drug: Control group(autologous ICBG)

Interventions

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.

Intervention group (DBM/BMP)

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.

Control group(autologous ICBG)

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Matthew Greives, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matthew Greives, MD

CONTACT

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

Tien Do, DO

CONTACT

Tien.Do@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: To prevent surgeon bias in operative time and therefore cost, randomization assignments will be concealed at the beginning of surgery. The surgeon will start with closure of the oronasal fistula first. Once that is completed, the envelope will be opened and reveal the type of bone graft selected. The surgeon will then either harvest the additional ICBG or open the packets for the DBM/BMP and pack the selected type of bone into the alveolus. Outcomes assessor including orthodontist and clinical research evaluator will be blinded to treatment arms.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 21, 2020
• Study Start: June 14, 2021
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)