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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
osteoimplant
Drug30 lower third molars will be selected and prescribed preoperative treatment with two units of Osteoimplant Complex® 5 days prior to surgery and postoperative treatment with one unit of Osteoimplant® for 8 weeks from the time of surgery. Both nutritional supplements will be administered every 24 hours.
Placebo
Drug30 lower wisdom teeth will be selected and prescribed placebo, both preoperatively 5 days prior to surgery and postoperatively for 8 weeks from the time of surgery.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: osteoimplantExperimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
diensional changes
Dimensional changes shall be assessed by a surgeon previously instructed by a specialised radiologist, by means of CBCT scans performed before (T0) and 8 weeks after (T1) extraction to obtain thus: Dimensional changes, evaluating the horizontal and vertical dimensions of hard tissue taking as a reference the amelocentric limit (LAC) of the adjacent tooth, so as to assess whether there has been loss of hard tissue following extraction and healing. For this purpose, three sections (A, B and C) shall be made at 5, 7 and 9 mm, taking as point 0 the imaginary horizontal line marked by the LAC of the adjacent tooth.
Time frame
From the extraction (T0) to 8 weeks after (T1) extractionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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