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Bone Grafting

Bone Grafting for Cleft Lip and Palate

Phase 4

Recruiting

Led By Matthew Greives, MD

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year post graft

Awards & highlights

Study Summary

This trial is to see if DMB/BMP is more cost effective and has less post-operative pain for patients with CLP compared to ICBG.

Who is the study for?

This trial is for patients with cleft lip and palate who have an open bone defect in the alveolus, cleared by an orthodontist for surgery. It excludes those with previous failed or successful alveolar bone grafts, without defects, non-consenting parents, or syndromic CLP.Check my eligibility

What is being tested?

The study compares two methods of alveolar bone grafting: one using Bone Morphogenic Protein/Demineralized Bone Matrix (DBM/BMP) and the other using autologous Iliac Crest Bone Graft (ICBG). It aims to assess cost-effectiveness, post-op pain, surgical time, and healing rates.See study design

What are the potential side effects?

Potential side effects may include discomfort at the donor site for ICBG patients and possible inflammatory reactions to DBM/BMP. Post-operative pain levels are being specifically measured as part of the trial's outcomes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year post graft

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year post graft

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year post graft for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Health system costs per successful bone graft.

Secondary outcome measures

Anesthesia Time

Drainage from Fistula

Fistula Recurrence

+8 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention group (DBM/BMP)Experimental Treatment1 Intervention

Patient undergoes Alveolar bone graft with DBM/BMP

Group II: Control group(autologous ICBG)Active Control1 Intervention

Patient undergoes Alveolar Bone Graft with Iliac Crest Bone graft.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor

903 Previous Clinical Trials

320,937 Total Patients Enrolled

3 Trials studying Cleft Lip and Palate

85 Patients Enrolled for Cleft Lip and Palate

Matthew Greives, MDPrincipal InvestigatorThe University of Texas Health Science Center, Houston

Media Library

Control group (autologous ICBG) (Bone Grafting) Clinical Trial Eligibility Overview. Trial Name: NCT04234971 — Phase 4

Cleft Lip and Palate Research Study Groups: Intervention group (DBM/BMP), Control group(autologous ICBG)

Cleft Lip and Palate Clinical Trial 2023: Control group (autologous ICBG) Highlights & Side Effects. Trial Name: NCT04234971 — Phase 4

Control group (autologous ICBG) (Bone Grafting) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04234971 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most populous cohort taking part in this medical study?

"Affirmative, the contents hosted on clinicaltrials.gov demonstrate that this medical study is presently seeking participants. First posted on June 14th 2021, it has since been amended as of 2nd June 2022 and requires 40 volunteers from one location to complete the trial."

Answered by AI

Is the age threshold for this trial's participants greater than 25 years old?

"Eligible patients for this study are between the ages of 6 and 15. There is an abundance of studies focusing on those younger than 18, with 17 trials in total, as well as 3 for people above 65 years old."

Answered by AI

Has the Intervention group (DBM/BMP) gained FDA authorization?

"Power's team assesses the security of Intervention group (DBM/BMP) to be a 3, as this is a Phase 4 trial and thus has been approved by regulatory authorities."

Answered by AI

Are there any open enrollments for this research trial?

"As indicated on clinicaltrials.gov, this medical study is currently recruiting patients. It was initially posted on June 14th 2021 and its information has been recently updated as of June 2nd 2022."

Answered by AI

Is there an opportunity to partake in this research endeavor?

"We are seeking 40 individuals aged 6 to 15 with cleft lip and palate, who have had their dentition evaluated by an orthodontist for approval of ABG surgery."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Matthew Greives 2021. "Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04234971.