Clinical trial NCT06338241: Osteogenic Action of a Biphasic Bioceramic With Statin in a Third Molar Extraction Model
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Bone Loss
Regenerative Inflammation
Lead sponsor: University of Santiago de Compostela
Sponsor class: OTHER
Collaborators: name: Universidad de Murcia
First posted: 2024-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Regeneration_Reduction in radiolucent volume
timeFrame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
measure: Bone Regeneration_bone volume
timeFrame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
measure: Bone Regeneration_bone density
timeFrame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
measure: Bone Regeneration_Fractal dimension
timeFrame: A) Immediately after extraction B) 1 month. C) 3 months. D) 6 months
Secondary outcomes:
measure: Pain levels through visual analog scale
timeFrame: 24 hours, 48 hours, 72 hours, and 7 days
measure: Clinical Inflammation evaluating by presence/absence
timeFrame: 24 hours, 48 hours, 72 hours, and 7 days
measure: Healing measured by healing index
timeFrame: 24 hours, 48 hours, 72 hours, and 7 days
measure: Post-surgical complications evaluated by presence or absense
timeFrame: 24 hours, 48 hours, 72 hours, and 7 days
measure: Oral Health-related Quality of Life measured by OHIP-14 test
timeFrame: 24 hours, 48 hours, 72 hours, and 7 days
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Faculty of Dentistry of Universidade de Santiago de Compostela
state: A Coruña
city: Murcia
country: Spain
facility: Faculty of Dentistry University of Murcia
Study officials:
affiliation: Universidade de Santaiago de Compostela
name: Abel García García, PhD, MD
role: STUDY_DIRECTOR
References: