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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Spain
      • Barcelona, Spain, 08172
        • International University of Catalunya

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitat Internacional de Catalunya

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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