Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid

Sinus Floor Augmentation Clinical Trial

Official title:

Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06156488
• Other study ID #: 0003-N-23
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: November 2024

Study information

• Verified date: November 2023
• Source: Universidad de Granada
• Contact: Miguel Padial-Molina, DDS, PhD
• Email: mipadial[@]ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: November 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Partially edentulous patients.

• Kennedy class I in the upper jaw.

• Less than 5 mm of residual crestal bone to the maxillary sinus.

• Need for the replacement of teeth with dental implants.

Exclusion Criteria:

• Sinus pathology (sinusitis, mucocele, cysts).

• Smokers.

• Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Related Conditions & MeSH terms

• Sinus Floor Augmentation

Intervention

Procedure:
• Maxillary sinus floor augmentation
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
• Maxillary sinus floor augmentation
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Galindo-Moreno P, Abril-Garcia D, Carrillo-Galvez AB, Zurita F, Martin-Morales N, O'Valle F, Padial-Molina M. Maxillary sinus floor augmentation comparing bovine versus porcine bone xenografts mixed with autogenous bone graft. A split-mouth randomized controlled trial. Clin Oral Implants Res. 2022 May;33(5):524-536. doi: 10.1111/clr.13912. Epub 2022 Mar 3. — View Citation

Galindo-Moreno P, de Buitrago JG, Padial-Molina M, Fernandez-Barbero JE, Ata-Ali J, O Valle F. Histopathological comparison of healing after maxillary sinus augmentation using xenograft mixed with autogenous bone versus allograft mixed with autogenous bone. Clin Oral Implants Res. 2018 Feb;29(2):192-201. doi: 10.1111/clr.13098. Epub 2017 Oct 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transcriptome analysis	Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement	6 months
Secondary	Sinus floor height change	CBCT scans will be performed after the sinus floor elevation and 6 months later before implant placement to calculate vertical bone height change	6 months