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Peri-implant MucositisNCT04805138

Influence of Soft Tissue Thickness Upon Dental Implant Esthetics

An observational study of Peri-implant Mucositis and Implant Complication, run by Universitat Internacional de Catalunya at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Peri-implant Mucositis, Implant Complication
What is being tested?
Spectrophotometer
How many people
42 participants
Where
1 siteSpain
Study dates
1 Apr 2019to 15 Sep 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Lack or minimal keratinized mucosa (<2mm)
  • patients with uncontrolled periodontal disease
  • active orthodontic therapy
  • restorations on contralateral teeth.

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • International University of Catalunya

    Barcelona, 08172

Other trials in Spain

About this study

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.

Being tested
Spectrophotometer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SpectrophotometerOther

    To objectively measure the discoloration of the peri-implant mucosa, spectrophotometric measurements of the buccal mucosa will be performed at study implant and at control tooth.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The influence of gingival thickness (GT) upon mucosal color (MC) around dental implants measured spectrophotometrically

    Measured: At least 1 year after definitive crown in place.

Secondary outcomes (1)
  1. A secondary goal is to evaluate the correlation between mucosal color changes and type of abutment material around dental implants.

    Measured: At least 1 year after definitive crown in place.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start1 Apr 2019
  3. Primary completion1 Sep 2021
  4. Study completion15 Sep 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805138
Sponsor's protocol ID
PER-ECL-2018-07
Status last verified
Nov 2021
First submitted
15 Mar 2021
Last updated
3 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Peri-implant Mucositis and Implant Complication, run by Universitat Internacional de Catalunya at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2021.

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