Osteoimplant and Dental Implants Stability
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversidad de Granada
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
This trial accepts healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
osteoimplant
Dietary supplementOsteoimplant 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.
Placebo Oral Tablet
Dietary supplement2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: OSTEOIMPLANT GROUPExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
IMPLANT STABILITY
All implants will be placed following the same surgical protocol and in strict compliance with the implant manufacturer's instructions regarding the drilling protocol associated with the patient's bone quality. Once the implants are placed, stability measurements shall be taken with the Osstell ISQ and the stability levels of the implants shall be evaluated at different stages of treatment by performing the following measurements: 1. First measurement: after implant placement surgery. We will evaluate the primary stability. 2. Second measurement: at 8 weeks to determine the evolution of osseointegration throughout the healing process of our implants. 3. Third measurement: at 12 weeks to assess the evolution of osseointegration again before subjecting the implant to occlusal loads. Prior to implant placement, each patient will be assigned to a study group, where, depending on their assignment, they will receive either placebo or the drug in question:
Time frame
From implant placement until 12 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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