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COMPLETED
NCT07557836
NA

A Comparative Clinical Study Evaluating Implant Stability and Peri-implant Marginal Bone Loss Between Two Implant Designs With Different Thread Configurations and Body Geometries

Sponsor: Career Postgraduate Institute of Dental Science and Hospital Lucknow

View on ClinicalTrials.gov

Summary

This clinical study was conducted to evaluate the effect of different dental implant designs on implant stability and peri-implant bone levels during the early healing phase. Dental implants are widely used for the replacement of missing teeth, and their long-term success depends on achieving adequate primary stability and maintaining the surrounding bone. Variations in implant design, including thread configuration and body geometry, may influence the mechanical and biological behavior of implants, thereby affecting treatment outcomes. The purpose of this study was to compare two different implant designs: double-threaded straight-body implants and triple-threaded conical-body implants. A total of 30 patients requiring implant-supported restorations in the posterior mandibular region were included in the study. Participants were randomly allocated into two groups, with each group receiving one type of implant design. Implant stability was assessed using Resonance Frequency Analysis (RFA), which provides Implant Stability Quotient (ISQ) values as an objective measure of stability. In addition, peri-implant marginal bone levels were evaluated using standardized intraoral radiographs. These measurements were recorded at three time points: at the time of implant placement (baseline), at 3 months, and at 6 months after placement. The primary objective of the study was to determine whether implant design influences implant stability over time. The secondary objective was to evaluate and compare marginal bone loss around the implants between the two groups during the early healing period. The main research question addressed in this study was: Does the difference in implant thread design and body geometry significantly affect implant stability and peri-implant marginal bone loss during the early healing phase? It was hypothesized that implants with a conical body design and multiple thread configuration may provide higher stability due to improved bone engagement and load distribution, while maintaining comparable bone levels around the implant. The findings of this study are expected to provide clinically relevant evidence regarding the influence of implant macro-design on treatment outcomes. This may assist dental practitioners in selecting appropriate implant systems to enhance primary stability, promote successful osseointegration, and improve long-term prognosis in implant therapy.

Official title: A COMPARATIVE STUDY TO EVALUATE IMPLANT STABILITY AND PERI-IMPLANT MARGINAL BONE LOSS AROUND TWO DIFFERENT THREAD AND BODY DESIGN OF IMPLANTS AT SPECIFIED TIME INTERVALS- AN IN VIVO STUDY

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2022-06-20

Completion Date

2023-12-12

Last Updated

2026-04-29

Healthy Volunteers

No

Interventions

DEVICE

Double-threaded straight-body dental implant

Placement of double-threaded, straight-body dental implants (Dentium NR Line) made of commercially pure titanium with an SLA surface. Implants were placed using a standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were assessed at baseline, 3 months, and 6 months.

DEVICE

Triple-threaded conical-body dental implant

Placement of triple-threaded, conical-body dental implants (MIS Lance+) made of commercially pure titanium with a sandblasted and acid-etched surface. Implants were placed using the same standardized two-stage surgical protocol in the posterior mandibular region. Implant stability and peri-implant marginal bone levels were evaluated at baseline, 3 months, and 6 months.

Locations (1)

Career Postgraduate Institute of Dental Science and Hospital, Lucknow, Indi

Lucknow, Uttar Pradesh, India