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

Implant Site Reaction Clinical Trial

Official title:

Comparison Between Value of Resonance Frequency Analysis (ISQ) in Implants Placed in Antral Area on Native Bone vs Value Obtained in Implants Placed in Antral Area on Regenerated Bone and Its Evolution After 3 Months

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06146244
• Other study ID #: CIPI/18/008
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: September 1, 2019

Study information

• Verified date: November 2023
• Source: European University of Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The stability of dental implants is influenced by the type of bone in which the implant is placed. Native bone tends to provide better initial stability due to its density and quality, while regenerated bone, it is logical to think that it may present less stability due to the quality of the generated bone and the presence of defects in the treated area. In this study it has been observed that after 3 months more stability is observed in the antral area, measured in ISQ resonance frequency in implants on regenerated bone, which surprises us and this result is explained in detail in said study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: September 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Implant Site Reaction

Intervention

Procedure:
• sinus lift
Implant placement on grafted sinus vs antral autogenous bone

Device:
• resonance frequency analysis
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

Locations

Country	Name	City	State
Spain	Dental Clinic of the UEM	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
European University of Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Insertion torque measurements	Analysis of the insertion torque values measured in Newtons per centimeter (Ncm) and comparing the results of both groups.	During implant placement
Secondary	Changes in the marginal bone	Analysis of the changes in the marginal bone three months after implant placement	3 months