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NCT06657521: OIMP

Osteoimplant and Dental Implants Stability

Not yet recruiting EARLY_PHASE1 Last updated 24 October 2024
What this trial tests

EARLY_PHASE1 trial testing osteoimplant in Primary Stability of the Implants in 60 participants. Not yet recruiting.

Timeline
1 January 2025
Primary endpoint
31 December 2025
31 December 2025

Quick facts

Lead sponsorUniversidad de Granada
PhaseEARLY_PHASE1
StatusNot yet recruiting
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingtriple
Primary purposetreatment
Enrollment60
Start date1 January 2025
Primary completion31 December 2025
Estimated completion31 December 2025

Drugs / interventions tested

Conditions studied

Sponsor

Universidad de Granada — full company profile →

Who can join

18 and older, any sex, with Primary Stability of the Implants or Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of osteoimplant

Trials testing the same drug.

Other Universidad de Granada trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06657521.

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