About this trial
Based on the scientific evidence, the relevance of this subject, we consider this study to be justified, the general or specific objective of which is as follows:
'To evaluate the effect of the administration of Osteoimplant© and Osteoimplant Complex© as a food supplement in obtaining implant stability and in the healing of dental implant surgery'.
As secondary objectives, we will also evaluate the effect of Osteoimplant© and Osteoimplant Complex© on pain, postoperative inflammation and soft tissue healing.
The sample will consist of 60 patients. The sample will be randomly divided into 2 groups using a randomisation table generated by a statistical programme. For blinding, neither the patient nor the operator shall be aware of the group to which each patient belongs. To ensure blinding, medication will be delivered in sealed, opaque envelopes. Patients shall be assigned to one of the following groups:
* Group I: 30 patients prescribed to take Osteoimplant Complex© on the following schedule: 2 tablets per day starting 5 days before implant placement and 1 tablet per day of Osteimplant© for 2 months after implant placement. * Group II: 30 patients who were prescribed placebo with the following regimen: 2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.
Eligibility criteria
Qualifiers
Patients presenting with unitary or partial edentulism.
Age: Between 18-75 years.
Anaesthetic risk ASA I-II.
Patients who do not abuse alcohol, drugs or chronic smoking (>10 cigarettes/day).
Disqualifiers
Age not between 18-75 years old.
Pregnant or breastfeeding women.
Chronic smokers (>10 cigarettes/day).
Patients with decompensated metabolic disease.
Trial design
Treatments tested in this trial
- osteoimplant
- Placebo Oral Tablet