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

Bone Loss Clinical Trial

— Galibone  

Official title:

Clinical Study to Analyze the Osteogenic Action of a Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model (Galibone+) in Bone Regeneration Following the Extraction of Impacted Mandibular Third Molars

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06338241
• Other study ID #: CPP2021-008391
• Status: Recruiting
• Phase: Phase 4
• Start date: March 2, 2024
• Est. completion date: September 2, 2025

Study information

• Verified date: April 2024
• Source: University of Santiago de Compostela
• Contact: MARIO PEREZ SAYANS GARCIA, PHD, PHD
• Phone: +34626233504
• Email: mario.perez[@]usc.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

With a focus on both clinical and radiological outcomes, the study seeks to compare the efficacy of Galibone+ against a standard material (Bio-Oss) through a double-blind, randomized split-mouth trial involving 30 patients. Variables including pain, inflammation, and post-surgical complications will be monitored during the initial seven-day follow-up, while bone volume reduction and mineral density will be evaluated radiographically over a six-month period. The study's findings promise to shed light on the potential of Galibone+ as a promising adjunct in enhancing bone regeneration following dental extractions, thereby advancing oral surgical practices and patient outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2, 2025
• Est. primary completion date: June 2, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bone Loss
• Inflammation
• Regenerative Inflammation

Intervention

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

Other:
• Bovine Hydroxyapatite
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.

Locations

Country	Name	City	State
Spain	Faculty of Dentistry University of Murcia	Murcia
Spain	Faculty of Dentistry of Universidade de Santiago de Compostela	Santiago De Compostela	A Coruña

Sponsors (2)

Lead Sponsor	Collaborator
Mario Pérez Sayáns	Universidad de Murcia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Pain levels through visual analog scale	Assessment of pain experienced by participants using a visual analog scale (VAS) at various time points post-extraction. It comprehends values between 0-10, where 10 is the worst situation.	24 hours, 48 hours, 72 hours, and 7 days
Secondary	Clinical Inflammation evaluating by presence/absence	Evaluation of postoperative inflammation around the extraction site using clinical examination and assessment tools (presence/absence).; The presence of inflammation means the worst prognosis.	24 hours, 48 hours, 72 hours, and 7 days
Secondary	Healing measured by healing index	The healing progress will be assessed using the Healing Index (HI) developed by Hamzani & Chaushu (2018) and Landry (1988). The HI score ranges from 0 to 5, where 0 indicates poor healing and 5 indicates excellent healing.; To ensure consistency and reliability in the assessment of healing, two independent researchers will evaluate the healing progress for all participants. The level of agreement between the researchers will be assessed using Cohen's Kappa index (Mandrekar, 2011). A Cohen's Kappa index value of 0.91 was achieved for the assessment of inflammation level, indicating a high degree of agreement. Similarly, agreement levels exceeding 0.90 were obtained across all HI levels, demonstrating a high level of concordance in the assessment of healing progress.	24 hours, 48 hours, 72 hours, and 7 days
Secondary	Post-surgical complications evaluated by presence or absense	Monitoring and recording of any complications following the extraction procedure, such as alveolitis, trismus, infection, and hematoma (presence/absence).; The presence of complications is related to a worse prognosis.	24 hours, 48 hours, 72 hours, and 7 days
Secondary	Oral Health-related Quality of Life measured by OHIP-14 test	Assessment of the impact of treatment on patients' quality of life using validated instruments (OHIP-14).; Lower scores: They indicate that the person experiences less impact of oral health problems on their quality of life. That is, they have fewer problems or feel less the impact of these problems in their daily lives.; Intermediate scores: Suggest a moderate impact of oral health problems on quality of life. The person may experience some difficulties or discomfort related to their oral health, but they do not necessarily significantly affect their daily functioning.; Higher scores: Indicate a significant impact of oral health problems on quality of life. The person may experience a wide range of problems that affect their general well-being, including pain, eating difficulties, sleep problems, etc.	24 hours, 48 hours, 72 hours, and 7 days