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

NCT06156488 | Active Not Recruiting

• 1 other identifier: 0003-N-23
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sinus Floor Augmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sinus floor height change

  6 months

Study Arms (2)

Anorganic bovine bone

ACTIVE COMPARATOR

Maxillary sinus floor augmentation grafted with anorganic bovine bone

Procedure: Maxillary sinus floor augmentation

Anorganic bovine bone + polynucleotides and hyaluronic acid

EXPERIMENTAL

Maxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid

Procedure: Maxillary sinus floor augmentation

Interventions

Maxillary sinus floor augmentation PROCEDURE

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

Anorganic bovine bone + polynucleotides and hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Sinus pathology (sinusitis, mucocele, cysts).
• Smokers.
• Previous long-term (\>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Universidad de Granada

Granada, Granada, 18009, Spain

Location

Related 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.

  PMID: 35224778 BACKGROUND

• 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.

  PMID: 29071736 BACKGROUND

MeSH Terms

Interventions

Sinus Floor Augmentation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Bone Transplantation; Orthopedic Procedures; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 5, 2023
• Study Start: September 4, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

ES (1)