Prospective Longitudinal Clinical Study for the Evaluation of Peri-implant Tissue and Osseointegration After Rehabilitation With Osseointegrated Implants

NCT06967649 | Enrolling By Invitation DMC

• 1 other identifier: DENTAL IMPLANTS EVALUATION
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The success of rehabilitation with osseointegrated implants is associated with numerous factors, including patient characteristics, installed implants, proper planning, and the prosthetic connections used. In the long term, success is closely related to the clinical radiographic follow-up of the implanted region and the identification of intrinsic or extrinsic factors that may interfere with implant survival. Therefore, the objective of this study is to evaluate, through clinical and radiographic analysis, the peri-implant tissues and prosthetic connections of research participants rehabilitated with osseointegrated implants at the Implant Dentistry Clinic of the Federal Fluminense University, over a period of 5 years. This will be a double-blind longitudinal study. A total of 148 research participants will be selected, respecting the inclusion criteria: completion of surgical-prosthetic planning by the Implant Dentistry Clinic team at UFF, including osseointegrated implants and prosthetic components manufactured by SIN Implant System (São Paulo, Brazil); agreeing to and signing the informed consent form, being willing to be monitored for a period of 5 years; systemically healthy patients who do not use antiresorptive and antiangiogenic drugs; patients with a plaque index \<20% (Ainamo \& Bay 1975) and bleeding on probing \<20% (Muhlemann \& Son 1971) at the start of the study. Participants will undergo clinical and radiographic analysis of peri-implant tissues and prosthetic connections at the following intervals: up to 7 days after implant installation (Time 0), at the time of prosthesis installation (Time 1), 6 months after prosthesis installation (Time 2), and 1 to 5 years after prosthesis installation (Times 3, 4, 5, 6, and 7, respectively). It is expected that this longitudinal study will lead to a better understanding of the factors influencing peri-implant bone loss and long-term success.

Conditions

Osseointegration Failure of Dental Implant; Periimplantitis; Peri-Implant Tissues; Peri-Implant Health; Peri-implant Soft Tissue Healing; Implant Survival Using Immediate Loading Protocol; Dental Implant Stability; Prospective Study; Osseointegration

Keywords

PERI-IMPLANT HEALTH; Dental implant survival rate; DENTAL IMPLANT; prospective study; osseointegration

Outcome Measures

Primary Outcomes (1)

• PRIMARY IMPLANT STABILITY

  Data on the clinical and radiographic characteristics of the different installed implants and the short-term stability of their prosthetic connections will be obtained. Over the years of evaluation, there may be better recognition of the factors influencing peri-implant bone loss and long-term success.

  From enrollment to the end of treatment at 6 months

Study Arms (1)

IMPLANT PLACEMENT

ACTIVE COMPARATOR

Research participants will undergo clinical and prosthetic planning (reverse planning), including clinical-tomographic examinations and complementary tests, such as biochemical blood analysis and, when necessary, surgical risk assessment, according to the UFF Implant Dentistry specialization course protocol. The surgical technique, type of implant installed, and selected prosthetic components will follow the manufacturer's recommendations (SIN Implant System, São Paulo, Brazil), always considering treatment options for optimal patient rehabilitation.

Device: TITANIUM IMPLANT

Interventions

TITANIUM IMPLANT DEVICE

The surgical technique, type of implant installed, and selected prosthetic components will follow the manufacturer's recommendations (SIN Implant System, São Paulo, Brazil), always considering treatment options for optimal patient rehabilitation.

IMPLANT PLACEMENT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Universidade Federal Fluminense

Niterói, Rio de Janeiro, 24020140, Brazil

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD in Morphology , Professor and Researcher at the Universidade Federal Fluminense

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: May 13, 2025
• Study Start: November 4, 2022
• Primary Completion: October 4, 2023
• Study Completion (Estimated): February 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)