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Osteoimplant and Dental Implants Stability

NCT06657521 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

  • Primary Stability of the Implants
  • Pain

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.

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-12-31
Completion
2025-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06657521 on ClinicalTrials.gov