Comparison of ISQ in Implants Placed in Antral Area on Native Bone vs Regenerated Bone

NCT06146244 | Completed FDA Device

• 1 other identifier: CIPI/18/008
• Study Type: observational
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

Compare ISQ values of implants placed in antral area in native bone vs regenerated bone with a follow-up at 3 months to compare values changes.

Conditions

Implant Site Reaction

Keywords

Implant placement; native bone; regenerated bone; resonance frequency analysis; ISQ value; Ostell

Outcome Measures

Primary Outcomes (1)

• Resonance frequency analysis (ISQ) measurements

  The day of surgery, data were collected by vestibular and palatal, in addition, the mean of both measurements was taken and ISQ data were collected vertically to complete all the information. After 3 months of implant placement we recorded the same measurements and compared them in native and regenerated bone.

  3 months

Secondary Outcomes (2)

• Insertion torque measurements

  During implant placement

• Changes in the marginal bone

  3 months

Study Arms (2)

Native bone

the evolution of the SSI and its change after 3 months of placing the implant in native bone in the antral area

Device: resonance frequency analysis

Regenerated Bone

the evolution of the SSI and its change after 3 months of placing the implant in regenerated bone in the antral area

Procedure: sinus lift; Device: resonance frequency analysis

Interventions

sinus lift PROCEDURE

Implant placement on grafted sinus vs antral autogenous bone

Also known as: alveolar preservation

Regenerated Bone

resonance frequency analysis DEVICE

analysis of the ISQ evolution and its changes after 3 months of placing the implant in native or regenerated bone, always in the antral area

Also known as: ISQ

Native bone; Regenerated Bone

Eligibility Criteria

• Age: 23 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study group is made up of adult patients from the UEM Dental University Clinic, from September 2017 to September 2018, who attended the Master's Degree in Advanced Oral Implantology and who were informed of the study and signed the informed consent.

You may qualify if:

• Adult patients
• Total superior edentulism or antral zone edentulism
• Accepted study and signed inform consent

You may not qualify if:

• Patients under 23 years old
• Non accepted study or signed inform consent

Sponsors & Collaborators

• European University of Madrid: lead

Study Sites (1)

Dental Clinic of the UEM

Madrid, 28045, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

we performed an ostell mesuarement on dental implants

MeSH Terms

Interventions

Resonance Frequency Analysis

Intervention Hierarchy (Ancestors)

Prosthodontics; Dentistry

Study Officials

• Sergio Trapote Mateo, PhD

  European University of Madrid

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOCIATE PROFESSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 24, 2023
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: September 1, 2019
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)