RecruitingPhase 4

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

United States40 participantsStarted 2021-06-14

Plain-language 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.

Who can participate

Age range6 Years – 15 Years

SexALL

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: * 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

What they're measuring

Health system costs per successful bone graft.

Timeframe: One year post graft

Trial details

NCT IDNCT04234971

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Matthew Greives, MD

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

View on ClinicalTrials.gov More Cleft Lip and Palate trials