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

NCT ID: NCT06156488

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-04

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Anorganic bovine bone

Maxillary sinus floor augmentation grafted with anorganic bovine bone

Group Type ACTIVE_COMPARATOR

Maxillary sinus floor augmentation

Intervention Type PROCEDURE

Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone

Anorganic bovine bone + polynucleotides and hyaluronic acid

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

Group Type EXPERIMENTAL

Maxillary sinus floor augmentation

Intervention Type PROCEDURE

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

Interventions

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Maxillary sinus floor augmentation

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

Intervention Type PROCEDURE

Maxillary sinus floor augmentation

Maxillary sinus floor augmentation through a lateral window grafted with anorganic bovine bone

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

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Miguel Padial-Molina

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad de Granada

Granada, Granada, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 35224778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29071736 (View on PubMed)

Other Identifiers

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0003-N-23

Identifier Type: -

Identifier Source: org_study_id

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