Overview
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.
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.