NCT05141851

Brief Summary

Some studies show that different types of threads in tapered implants result in differences in primary stability. The aim of this study is to a perform a prospective, controlled, randomized clinical trial comparing primary and secondary stability between long and standard thread implants in the treatment of partial edentulous patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 2, 2021

Completed
Last Updated

December 2, 2021

Status Verified

November 1, 2021

Enrollment Period

1.6 years

First QC Date

November 20, 2021

Last Update Submit

December 1, 2021

Conditions

Keywords

implant stability; implant threads

Outcome Measures

Primary Outcomes (1)

  • primary dental implant stability

    measuring the ISQ value (implant stability quotient)

    On the 1 day of implants placement

Study Arms (2)

Implants with 0,7mm threads

ACTIVE COMPARATOR

Placement of Implants with 0,7mm threads

Device: Implants with 0,7 mm threads

Implants with 0,3mm threads

ACTIVE COMPARATOR

Placement of Implants with 0,3mm threads

Device: Implants with 0.3 mm threads

Interventions

Implants were placed, with threads of 0.7 mm in the location of premolars and molars.

Implants with 0,7mm threads

Implants were placed, with threads of 0.3 mm in the location of premolars and molars.

Implants with 0,3mm threads

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Minimum 18 years;
  • No systemic conditions that contraindicate surgery;
  • Periodontal health or periodontal disease treated as part of a periodontal support program and having a high level of plaque control;
  • Partial edentulous patients, in the upper jaw, specifically in the location of premolars and molars;

You may not qualify if:

  • Patients with insufficient quantity of bone for implant placement without bone regeneration procedures;
  • Patients who underwent medication that could affect stability and osteointegration up to 3 months prior to study initiation;
  • Patients with untreated periodontal pathology or who have not followed periodontal supportive treatment;
  • Smokers, Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanessa Rodirgues

Lisbon, Portugal

Location

Study Officials

  • Paulo Mascarenhas, PhD

    University of Lisbon

    STUDY DIRECTOR
  • Susana Noronha, PhD

    University of Lisbon

    STUDY DIRECTOR
  • Vanessa Rodrigues, Dr

    University of Lisbon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vanessa Rocha Rodrigues

Study Record Dates

First Submitted

November 20, 2021

First Posted

December 2, 2021

Study Start

June 19, 2018

Primary Completion

February 4, 2020

Study Completion

June 15, 2020

Last Updated

December 2, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations