- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805138
Influence of Soft Tissue Thickness Upon Dental Implant Esthetics
November 2, 2021 updated by: Gonzalo Blasi, Universitat Internacional de Catalunya
Since the beginning of the implant dentistry, a large variety of materials have been used for restoring single or multiple implants, such as gold, titanium, alumina (Al2O3), and zirconia (ZrO2).
Patient physical and esthetic requirements play one of the most important role in making decisions related to which material should be chosen.
In fact, long-term stability, compatibility with oral tissues esthetics and costs should be considered.
Several studies demonstrated that both titanium and zirconia have an excellent biocompatibility and long-term stability even though something could change in terms of esthetic outcomes.
Related to esthetics, the color of the peri-implant mucosa is an essential factor that clinicians have to take in to account.
Unfortunately, discoloration of peri-implant mucosa sometimes happens.
Some authors hypothesized that titanium abutments could provoke a grayish appearance of the mucosa, and, in order to avoid this problem, other authors suggested to perform augmentation of the peri-implant soft tissue thickness in the esthetic area.
A study on pig maxillae found that the type of abutment or crown material and the mucosa thickness have significant influences on color changes of the mucosa.
Titanium induced the most prominent color change, and, in patients with thinner mucosa, zirconia induced the least noticeable color changes.
Nowadays, to reliably evaluate differences in color in implantology, the most used method is spectrophotometry, due to the capacity of detecting even small color differences and due to the higher reproducibility.
Several investigations on pig jaws using spectrophotometric measurements were carried out recently, with the aim of investigating the color changes.
It was found that generally titanium abutment lead to a more pronounced discoloration; however, gingival thickness greater than 2 mm did not reveal any difference related to the type of abutments.
In addition, an increase in mucosal thickness might minimize the discoloration.
The only study on human patients revealed that the color of the peri-implant mucosa presents more dark, green and blue components compared to the natural gingiva.
Soft tissue thickness appeared a crucial factor with respect to the spectrophotometrically measured degree of peri-implant mucosal discoloration, with a trend for less pronounced discolorations in patients with thick mucosa.
Furthermore, the authors found that peri-implant mucosa was on average 0,5-0,7 mm thicker than natural gingiva.
However, this study evaluated the thickness of the gingiva by means of CBCT, which could lead to some errors due to the superimposition of the lips and cheeks, as well as the tongue that occupies the most space of the oral cavity.
Moreover, esthetics were evaluated by clinicians visually at a specific distance asking them if discoloration was visible or not visible.
Furthermore, no questionnaire was given to patients to evaluate esthetics neither discomfort while brushing.
Therefore, The objective of this cross-sectional study is to evaluate the influence of gingival thickness (GT) upon mucosal color (MC) around dental implants measured spectrophotometrically.
A secondary goal is to evaluate the correlation between mucosal color changes and type of abutment material around dental implants.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
42
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
-
-
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Barcelona, Spain, 08172
- International University of Catalunya
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Subjects with at least one dental implant in the anterior upper maxilla (right first premolar to left first premolar).
They will be selected, on a consecutive basis, among individuals referred to the periodontology department clinic floor.
Description
Inclusion Criteria:
- Subjects older than18 years old,
- periodontally and systemically healthy
- presence of at least one dental implant placed on the upper anterior maxilla, with a follow-up period of at least 1 year after prosthesis delivery
- full-mouth plaque and bleeding score ≤20%; presence of adjacent teeth
- no signs of peri-implant inflammation
- bleeding on probing or suppuration
- complete medical and dental history report.
Exclusion Criteria:
- Lack or minimal keratinized mucosa (<2mm)
- patients with uncontrolled periodontal disease
- active orthodontic therapy
- restorations on contralateral teeth.
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The influence of gingival thickness (GT) upon mucosal color (MC) around dental implants measured spectrophotometrically
Time Frame: At least 1 year after definitive crown in place.
|
At least 1 year after definitive crown in place.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
A secondary goal is to evaluate the correlation between mucosal color changes and type of abutment material around dental implants.
Time Frame: At least 1 year after definitive crown in place.
|
At least 1 year after definitive crown in place.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2019
Primary Completion (Actual)
September 1, 2021
Study Completion (Actual)
September 15, 2021
Study Registration Dates
First Submitted
March 15, 2021
First Submitted That Met QC Criteria
March 17, 2021
First Posted (Actual)
March 18, 2021
Study Record Updates
Last Update Posted (Actual)
November 3, 2021
Last Update Submitted That Met QC Criteria
November 2, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PER-ECL-2018-07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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