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NOT YET RECRUITING
NCT06657521
EARLY_PHASE1

Osteoimplant and Dental Implants Stability

Sponsor: Universidad de Granada

View on ClinicalTrials.gov

Summary

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.

Official title: Influence of the Osteoimplant Vitamin Complex on the Stability of Dental Implants. Randomized Double-blind Clinical Trial.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-01-01

Completion Date

2025-12-31

Last Updated

2024-10-24

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

osteoimplant

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.

DIETARY_SUPPLEMENT

Placebo Oral Tablet

2 tablets per day starting 5 days before implant placement and 1 tablet per day for 2 months after implant placement.