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

May 9, 2026 updated by: Miguel Padial-Molina, Universidad de Granada
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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Granada
      • Granada, Granada, Spain, 18009
        • Universidad de Granada

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anorganic bovine bone
Maxillary sinus floor augmentation grafted with anorganic bovine bone
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone
Experimental: Anorganic bovine bone + polynucleotides and hyaluronic acid
Maxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcriptome analysis
Time Frame: 6 months
Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sinus floor height change
Time Frame: 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Actual)

September 30, 2025

Study Completion (Actual)

September 30, 2025

Study Registration Dates

First Submitted

November 25, 2023

First Submitted That Met QC Criteria

November 25, 2023

First Posted (Actual)

December 5, 2023

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 9, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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