- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05141851
The Impact of Thread Length on Implant Stability
December 1, 2021 updated by: Vanessa Rocha Rodrigues, University of Lisbon
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The study sample consists of 23 maxillary partial edentulous patients, where 32 implants were placed, with threads of 0.7 mm or 0.3 mm in the location of premolars and molars.
The comparison, in terms of primary stability, is made by measuring the ISQ value (implant stability quotient), in four locations (buccal, palatal, mesial and distal).
Statistical analysis was performed using the independent T-Test.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lisboa, Portugal
- Vanessa Rodirgues
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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;
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Implants with 0,7mm threads
Placement of Implants with 0,7mm threads
|
Implants were placed, with threads of 0.7 mm in the location of premolars and molars.
|
Active Comparator: Implants with 0,3mm threads
Placement of Implants with 0,3mm threads
|
Implants were placed, with threads of 0.3 mm in the location of premolars and molars.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary dental implant stability
Time Frame: On the 1 day of implants placement
|
measuring the ISQ value (implant stability quotient)
|
On the 1 day of implants placement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paulo Mascarenhas, PhD, University of Lisbon
- Principal Investigator: Vanessa Rodrigues, Dr, University of Lisbon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 19, 2018
Primary Completion (Actual)
February 4, 2020
Study Completion (Actual)
June 15, 2020
Study Registration Dates
First Submitted
November 20, 2021
First Submitted That Met QC Criteria
December 1, 2021
First Posted (Actual)
December 2, 2021
Study Record Updates
Last Update Posted (Actual)
December 2, 2021
Last Update Submitted That Met QC Criteria
December 1, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- The impact of thread length on
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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