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OpenTrials
Completed

NCT Number: NCT06156488

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

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.

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Key information

Conditions

Sinus Floor Augmentation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Granada

Granada, 18009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Totally edentulous maxilla or 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).
  • Heavy smokers (>10 cigarettes/day).
  • Previous long-term (>3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.

Treatment and study plan

Maxillary sinus floor augmentation

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Other outcomes

  1. Histomorphometric analysis of bone tissue compartments

    Time frame: 6 months

    Relative (%) areas of mineralized and non-mineralized bone tissue together with residual graft will be quantified.

  2. Micro-CT analysis of bone tissue compartments

    Time frame: 6 months

    Bone volume (in mm^3)

  3. Micro-CT analysis of bone tissue compartments

    Time frame: 6 months

    Bone surface (in mm^2)

  4. Micro-CT analysis of bone tissue compartments

    Time frame: 6 months

    Average trabecular thickness (in µm)

  5. Micro-CT analysis of bone tissue compartments

    Time frame: 6 months

    Structure model index

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2023
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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