- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06156488
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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.
General Publications
- 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.
- 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0003-N-23
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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