Osteoimplant and Dental Implants Stability

NCT06657521 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 4054/CEIH/2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Dental implant; vitamin c; vitamin D; stability; pain; inflamation

Outcome Measures

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:

  From implant placement until 12 weeks

Study Arms (2)

OSTEOIMPLANT GROUP

EXPERIMENTAL

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.

Dietary Supplement: osteoimplant

Placebo Group

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo Oral Tablet

Interventions

osteoimplant DIETARY_SUPPLEMENT

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.

OSTEOIMPLANT GROUP

Placebo Oral Tablet DIETARY_SUPPLEMENT

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

Placebo Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients with adequate periodontal status (≤10% plaque index and bleeding index).
• Absence of drug allergies that could compromise our study.
• Absence of allergy to any of the components of Osteoimplant© and Osteimplant Complex©.
• Signed informed consent.

You may not qualify if:

• Age not between 18-75 years old.
• Pregnant or breastfeeding women.
• Chronic smokers (\>10 cigarettes/day).
• Patients with decompensated metabolic disease.
• Poor periodontal status (≥10% plaque index and bleeding index).
• Patients allergic to any of the components of Osteoimplant© and Osteimplant Complex©.
• Patients undergoing treatment with drugs that could affect the bone regeneration process, such as chemotherapy drugs, bisphosphonates, corticosteroids or immunosuppressants.
• Patients with metabolic bone diseases or who have undergone radiotherapy in the last five years.
• Patients with hypercalcaemia or a tendency to hypercalcification, taking vitamin D or calcium supplements.
• Patients with a history of renal colic.
• Patients who are not going to undergo nephrotic colic.

Sponsors & Collaborators

• Universidad de Granada: lead

Related Publications (5)

• Chen MH, Lyons KM, Tawse-Smith A, Ma S. Clinical Significance of the Use of Resonance Frequency Analysis in Assessing Implant Stability: A Systematic Review. Int J Prosthodont. 2019 Jan/Feb;32(1):51-58. doi: 10.11607/ijp.6048.

  PMID: 30677112 RESULT

• Werny JG, Sagheb K, Diaz L, Kammerer PW, Al-Nawas B, Schiegnitz E. Does vitamin D have an effect on osseointegration of dental implants? A systematic review. Int J Implant Dent. 2022 Apr 11;8(1):16. doi: 10.1186/s40729-022-00414-6.

  PMID: 35403929 RESULT

• Dermience M, Lognay G, Mathieu F, Goyens P. Effects of thirty elements on bone metabolism. J Trace Elem Med Biol. 2015 Oct;32:86-106. doi: 10.1016/j.jtemb.2015.06.005. Epub 2015 Jun 26.

  PMID: 26302917 RESULT

• Choi HK, Kim GJ, Yoo HS, Song DH, Chung KH, Lee KJ, Koo YT, An JH. Vitamin C Activates Osteoblastogenesis and Inhibits Osteoclastogenesis via Wnt/beta-Catenin/ATF4 Signaling Pathways. Nutrients. 2019 Feb 27;11(3):506. doi: 10.3390/nu11030506.

  PMID: 30818817 RESULT

• Kim JH, Lim YJ, Kim B, Lee J. How Do Parameters of Implant Primary Stability Correspond with CT-Evaluated Bone Quality in the Posterior Maxilla? A Correlation Analysis. Materials (Basel). 2021 Jan 7;14(2):270. doi: 10.3390/ma14020270.

  PMID: 33430383 RESULT

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

FRANCISCO JAVIER MANZANO-MORENO Prof. Dr. Francisco Javier Manzano-Moreno, PhD, DDS

CONTACT

+34651606228; fjmanza@ugr.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Doctor in Dental Surgery

Study Record Dates

• First Submitted: October 23, 2024
• First Posted: October 24, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10