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The Influence of a New Implant Neck Configuration on Hard and Soft Tissue Healing

NCT04308083 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2020-03-13

No results posted yet for this study

Summary

Title: Randomized Controlled Clinical Trial comparing two dental implants with different neck configurations.

Objective: To evaluate the changes in peri-implant soft tissues and marginal bone level when using a one-piece implant with a widening transgingival machined collar and a one-piece implant with a tapering transgingival machined collar.

Design: The study will be a prospective parallel randomized clinical trial with a 12 month follow up conducted in 5 private dental practices. A total of 50 patients meeting the inclusion criteria will be randomized in one of the two groups to receive 1 single implant placed in healed ridges. Radiographic and clinical measurements will be taken post-insertion, baseline (post-loading) 6 and 12 months after loading.

Study Hypothesis: The hypothesis of this study is that there will be no differences in the preservation of the peri-implant marginal bone level and peri-implant soft tissues between the two implant neck designs.

Conditions

  • Implant Geometry, Osseointegration, Soft Tissue Volume, Marginal Bone Levels, Soft Tissue Recession, Volumetric Analysis

Interventions

PROCEDURE

dental implant placement

Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.

Sponsors & Collaborators

  • PerioCentrum Research

    lead OTHER

Principal Investigators

  • Fabio Vignoletti, PhD · PerioCentrum Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-17
Primary Completion
2020-11-17
Completion
2021-03-17

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04308083 on ClinicalTrials.gov