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

Not Applicable

Active, not recruiting

• Conditions: Sinus Floor Augmentation
• Interventions: Procedure: Maxillary sinus floor augmentation

• Registration Number: NCT06156488
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-04
• Study First Submitted: 2023-11-25
• Study First Submitted QC: 2023-11-25
• Study First Posted: 2023-12-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anorganic bovine bone + polynucleotides and hyaluronic acid	Maxillary sinus floor augmentation	Maxillary sinus floor augmentation grafted with anorganic bovine bone + polynucleotides and hyaluronic acid
Anorganic bovine bone	Maxillary sinus floor augmentation	Maxillary sinus floor augmentation grafted with anorganic bovine bone

Primary Outcome Measures

Name	Time	Method
Transcriptome analysis	6 months	Transcriptome analysis of a sample of the regenerated bone will be performed 6 months after grafting immediately before implant placement

Secondary Outcome Measures

Name	Time	Method
Sinus floor height change	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

Trial Locations

Locations (1)

Universidad de Granada; 🇪🇸 Granada, Spain