Alveolar Cleft Reconstruction Powered by

NCT04886947 | Unknown

• 1 other identifier: MAKRIF/DVCFA/025/20
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

More than four million children are born with birth defects worldwide every year and a million presenting with cleft lip and palate. Cleft lip and palate is a congenital defect of the lip alveolar and palate it's now recognized as a significant cause of infant mortality and childhood morbidity and included among global burden of disease initiative. In Uganda the estimated number of babies born with cleft lip and palate is 1100 per year Children with 75% of them having alveolar cleft which is a defect in the upper jaw (Maxilla arch). The secondary bone graft and gingivoperiosteoplasty have become the two popular approaches to bone generation in alveolar defect. These two methods have varying success rates; primary gingivoperiosteoplasty 50 to 60% and secondary bone graft is 87% but Gingivoperiosteoplasty is the preferred option to many African surgeons to obviate the need for bone grafting which is technically demanding, prolonging therapy with many procedures therefore poor compliance, also increasing treatment failure rate and has significant associated donor morbidity. This project is set out to address the challenge of bone regeneration in alveolar cleft and improve on the surgical outcome by the use of stem cell therapy. The objective of this study is to compare the outcome of umbilical cord blood stem cell transplant plus gingivoperiosteoplasty to conventional gingivoperiosteoplasty on timing and density of bone regeneration. 1.3. Hypothesis In this study we hypothesize that primary repair with gingivoperiosteoplasty the success rate can be improved or enhanced with the use of stem cell therapy in our setting. Alternative hypothesis: Autologous umbilical stem cells transplantation following gingivoperiosteoplasty results in better bone regeneration when compared to gingivoperiosteoplasty. Null hypothesis: Autologous umbilical stem cells transplantation following gingivoperiosteoplasty has no benefit on promoting bone regeneration when compared to gingivoperiosteoplasty alone. The study will be a case control pilot study conducted in Kiruddu National Referral hospital Kampala Uganda. 20 participants who will be neonates of either sex with unilateral cleft lip and palate will be recruited in the study. They will be split into two groups: group A will have the umbilicus cord and placenta blood collected at birth and group B will not have umbilical cord or placenta blood collected and will be designated as the Control group.

Conditions

Alveolar Cleft

Keywords

alveolar cleft stem cell gingivoperiosteoplasty

Outcome Measures

Primary Outcomes (2)

• Alveolar bone density

  Alveolar bone density: this will be measured in mm by one radiologist.

  6 months

• Alveolar bone volume

  Chelsea scale will be used to score the alveolar bone volume.

  6 months

Other Outcomes (1)

• Development of side effects.

  one month

Study Arms (1)

stem cell intervention

EXPERIMENTAL

Arm A patients who will have surgery with stem cell added. Arm B only surgery with no stem cell added.

Procedure: stem cell transplantation

Interventions

stem cell transplantation PROCEDURE

After surgical repair of alveolar cleft using gingivoperiosteoplasty, processed and stored autologous stem cells will be added at the repair site. After which the patient will be followed up for bone regeneration and this will be compared to control where no stem cell is added.

stem cell intervention

Eligibility Criteria

• Age: 3 Months - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates with unilateral cleft lip and palate and having clinical evidence of alveolar defect.

You may not qualify if:

• \- Patients with very wide cleft lip and palate Patients whose parents refuse consent Patients with Syndromic cleft

Sponsors & Collaborators

• Makerere University: lead

Related Publications (5)

• Coots BK. Alveolar bone grafting: past, present, and new horizons. Semin Plast Surg. 2012 Nov;26(4):178-83. doi: 10.1055/s-0033-1333887.

  PMID: 24179451 BACKGROUND

• Mazzetti MPV, Alonso N, Brock RS, Ayoub A, Massumoto SM, Eca LP. Importance of Stem Cell Transplantation in Cleft Lip and Palate Surgical Treatment Protocol. J Craniofac Surg. 2018 Sep;29(6):1445-1451. doi: 10.1097/SCS.0000000000004766.

  PMID: 30067525 BACKGROUND

• Bajestan MN, Rajan A, Edwards SP, Aronovich S, Cevidanes LHS, Polymeri A, Travan S, Kaigler D. Stem cell therapy for reconstruction of alveolar cleft and trauma defects in adults: A randomized controlled, clinical trial. Clin Implant Dent Relat Res. 2017 Oct;19(5):793-801. doi: 10.1111/cid.12506. Epub 2017 Jun 28.

  PMID: 28656723 BACKGROUND

• Bhattacharya S, Khanna V, Kohli R. Cleft lip: The historical perspective. Indian J Plast Surg. 2009 Oct;42 Suppl(Suppl):S4-8. doi: 10.4103/0970-0358.57180.

  PMID: 19884680 BACKGROUND

• Tanikawa DYS, Pinheiro CCG, Almeida MCA, Oliveira CRGCM, Coudry RA, Rocha DL, Bueno DF. Deciduous Dental Pulp Stem Cells for Maxillary Alveolar Reconstruction in Cleft Lip and Palate Patients. Stem Cells Int. 2020 Mar 12;2020:6234167. doi: 10.1155/2020/6234167. eCollection 2020.

  PMID: 32256610 BACKGROUND

MeSH Terms

Interventions

Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• naknwagi cephas, bachelor

  Makerere University

  STUDY DIRECTOR

Central Study Contacts

rose alenyo, m.med

CONTACT

0772608026; alenyom@yahoo.co.uk

ronald mbine, m.med

CONTACT

0774338585; mbineron@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The radiologist interpreting bone formation of the alveolar will be blinded on which group the participants belongs. whether no or intervention done
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: case control study with control being those receiving convectional treatment and cases those will have added intervention of autologues stem cell

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: June 1, 2021
• Primary Completion: November 30, 2021
• Study Completion: June 30, 2022
• Last Updated: May 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share