Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model

NCT06338241 | Recruiting Phase 4

• 1 other identifier: CPP2021-008391
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

The clinical study aims to assess the osteogenic effects of Galibone+ in bone regeneration post-extraction of impacted mandibular third molars.

Conditions

Bone Loss; Regenerative Inflammation

Outcome Measures

Primary Outcomes (4)

• Bone Regeneration_Reduction in radiolucent volume

  This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Reduction in radiolucent volume within the extraction socket, indicating new bone formation (Hounsfield unit (HU)). High values mean more radiopacity and better regeneration.

  A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

• Bone Regeneration_bone volume

  This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone volume within the extraction site over time (mm3). The increase in bone volume means better regeneration.

  A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

• Bone Regeneration_bone density

  This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Changes in bone density within the regenerated bone tissue (Hounsfield unit (HU)) High values mean more radiopacity and better regeneration.

  A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

• Bone Regeneration_Fractal dimension

  This outcome measure involves assessing the degree of bone regeneration in the extraction socket following the extraction of impacted mandibular third molars. It will be evaluated through radiological imaging using CBCT scans at specified time points, including immediately post-extraction, at one month, three months, and six months post-extraction. Evaluation of bone morphology within the extraction site over time analyzing the fractal dimension (FD) FD can vary between 1 and 2, with 1 being a very simple fractal dimension (such as a straight line) and 2 being a more complex fractal dimension (such as a completely irregular surface).

  A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months

Secondary Outcomes (5)

• Pain levels through visual analog scale

  24 hours, 48 hours, 72 hours, and 7 days

• Clinical Inflammation evaluating by presence/absence

  24 hours, 48 hours, 72 hours, and 7 days

• Healing measured by healing index

  24 hours, 48 hours, 72 hours, and 7 days

• Post-surgical complications evaluated by presence or absense

  24 hours, 48 hours, 72 hours, and 7 days

• Oral Health-related Quality of Life measured by OHIP-14 test

  24 hours, 48 hours, 72 hours, and 7 days

Study Arms (2)

Galibone Group

EXPERIMENTAL

The Galibone+ experimental group includes participants receiving Galibone+ after impacted mandibular third molar extraction, testing its osteogenic properties. Galibone+ is prepared per manufacturer's instructions, potentially by immersing in sterile saline. Applied post-extraction into the socket using specialized instruments, it's compared to a control group receiving Bio-Oss, a standard xenograft material. Experimental group patients receive postoperative medications, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation. Goal: Assess Galibone+'s efficacy in bone regeneration versus control.

Combination Product: Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin

Control group

ACTIVE COMPARATOR

The control group serves as an active comparator to the Galibone+ experimental group in this study. Participants undergo identical impacted mandibular third molar extraction procedures as the experimental group but receive a standard material, likely Bio-Oss, instead of Galibone+. Bio-Oss, a widely used xenograft material in dental surgeries, acts as a benchmark due to its osteoconductive properties. Applied post-extraction into the socket with specialized instruments, it provides a reference for comparing Galibone+'s efficacy. Patients in the control group receive postoperative medications as per the study protocol, including antibiotics and pain management. Follow-up assesses pain, inflammation, complications, and bone regeneration via radiological evaluation.

Other: Bovine Hydroxyapatite

Interventions

Biphasic bioceramic of tricalcium phosphate and hydroxyapatite with simvastatin COMBINATION_PRODUCT

The intervention description for Galibone+ in the study involves the application of this substance to promote bone regeneration following the extraction of impacted mandibular third molars. Galibone is indicated to treat segmental and cavity bone loss, aesthetic repairs and bone augmentations (such as inlay or onlay grafts); to fill dental alveolar bone; for the placement of dental implants; for the stabilization of osteotomies and prostheses in dentistry.

Also known as: Galibone

Galibone Group

Bovine Hydroxyapatite OTHER

The intervention description for Bio-Oss in the study involves the application of this standard material to promote bone regeneration following the extraction of impacted mandibular third molars. Bio-Oss is a commonly used xenograft material known for its osteoconductive properties.

Also known as: Bio-Oss

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must be of legal age.
• Participants must provide informed consent for participation in the study.
• Participants must require extraction of both impacted mandibular third molars.
• Both impacted molars must exhibit a similar level of complexity for extraction.
• Participants must have no history of infection in the impacted molars prior to extraction.
• Participants must not have any contraindications to undergoing oral surgical procedures (ASA I/II classification).

You may not qualify if:

• Participants with severe mental disorders that may impair their ability to provide informed consent or follow study instructions.
• Participants currently receiving medications contraindicated for dental extractions.
• Participants under the age of legal consent.
• Participants who have undergone head and neck radiotherapy within the past 18 months.

Sponsors & Collaborators

• Mario Pérez Sayáns: lead
• Universidad de Murcia: collaborator

Study Sites (2)

Faculty of Dentistry of Universidade de Santiago de Compostela

Santiago de Compostela, A Coruña, 15705, Spain

RECRUITING

Faculty of Dentistry University of Murcia

Murcia, Spain

RECRUITING

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Durapatite; Simvastatin; Bio-Oss

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Hydroxyapatites; Apatites; Calcium Phosphates; Phosphates; Phosphoric Acids; Phosphorus Acids; Acids, Noncarboxylic; Acids; Inorganic Chemicals; Calcium Compounds; Minerals; Phosphorus Compounds; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Abel García García, PhD, MD

  Universidade de Santaiago de Compostela

  STUDY DIRECTOR

Central Study Contacts

MARIO PEREZ SAYANS GARCIA, PHD, PHD

CONTACT

+34626233504; mario.perez@usc.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator of ORALRES Group

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 29, 2024
• Study Start: March 2, 2024
• Primary Completion: June 2, 2025
• Study Completion: September 2, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)