Clincosm LogoSign in Get a demo

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

Sponsor
Universidad de Granada (Other)
Overall Status
Recruiting
CT.gov ID
NCT06156488
Collaborator
(none)
6
Enrollment
1
Location
2
Arms
13.9
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Maxillary sinus floor augmentation
  • Procedure: Maxillary sinus floor augmentation
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid
Actual Study Start Date :
Sep 4, 2023
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Nov 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anorganic bovine bone

Maxillary sinus floor augmentation grafted with anorganic bovine bone

Procedure: Maxillary sinus floor augmentation
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

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Universidad de Granada Granada Spain 18009

Sponsors and Collaborators

  • Universidad de Granada

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Miguel Padial-Molina, Associate Professor, Universidad de Granada
ClinicalTrials.gov Identifier:
NCT06156488
Other Study ID Numbers:
  • 0003-N-23
First Posted:
Dec 5, 2023
Last Update Posted:
Dec 5, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 5, 2023