Osteoimplant and Bone Healing
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorUniversidad de Granada
About this trial
In view of the above and the possible improvements in terms of postoperative morbidity and tissue repair in oral surgery, this study is justified, the general objective of which would be:
'To evaluate the efficacy of perioperative oral administration of two nutritional supplements based on vitamins and antioxidants (Osteoimplant Complex® and Osteoimplant®), using mandibular third molar surgery as a study model, assessing postoperative symptomatology and bone density'.
The null hypothesis of this study is: 1) the administration of the perioperative nutritional complex (Osteoimplant Complex® and Osteoimplant®) did not improve postoperative symptoms and 2) neither did it increase bone density after lower third molar extraction.
Eligibility criteria
Qualifiers
Patients presenting both lower third molars.
Adult patients between 18 and 40 years of age.
Anaesthetic risk ASA I-II (American Society of Anaesthesiologists classification) [14].
Absence of drug or food allergies that could compromise our study (e.g. egg).
Disqualifiers
Age not between 18-40 years.
Pregnant or breastfeeding women.
Presenting decompensated metabolic disease.
Poor periodontal status (≥10% plaque index and bleeding index).
Trial design
Treatments tested in this trial
- osteoimplant
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov