Risk Assessment of Proximal Contact Loss Between Implant-supported Prostheses and Adjacent Teeth.

June 20, 2024 updated by: Nanjing First Hospital, Nanjing Medical University
In this study, we collected and analysed the review results of 100 patients over 18 years of age who received implant fixed restorations in the Department of Stomatology of the First Hospital of Nanjing, China. The aim was to investigate the incidence of loss of contact between implant restorations and adjacent teeth and its influencing factors. Our findings may provide better insights for treatment planning and prevention of PCL.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

Detailed Description

Food impaction is a common complication after implant-supported restorations. Several studies have reported that more than 40%-66.9% of patients feel food impaction between the implant restoration and adjacent natural teeth. The most common cause of food impaction after implant restoration is the proximal contact loss(PCL), which has been reported to occur in 34% to 65% of cases. The location of PCL creates discomfort and leads to gingival inflammation and even peri-implant bone resorption, which ultimately leads to loosening of the implant. In our long-term clinical observation, not all final restorations suffer from PCL. The occurrence of PCL may be related to a number of factors such as age, gender, functional time, and so on. However, the literature addressing this issue is still limited. In this study, we collected and analysed the review results of selected patients who underwent implant-supported restorations in the First Hospital of Nanjing, China, to investigate the incidence of PCL between the implant restorations and the adjacent teeth adjacent , and the factors influencing it. Our findings may provide better insights for treatment planning and prevention of PCL.

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 (Estimated)

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.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

One hundred consecutive patients, who had received either implant-supported fixed partial denture (FPD) or implant-supported single crown (SC) in the posterior region and were under regular review, were recruited.

Description

Inclusion Criteria:

  • (1) Patients over the age of 18, can fully understand the nature of the proposed and be able to sign a consent form.
  • (2) patients who underwent dental implant surgery and delivered prostheses for more than 3 months in Nanjing First Hospital.

Exclusion Criteria:

  • (1) The implant site or adjacent teeth were severely injured and the adjacent teeth were extracted;
  • (2) the same quadrant orthodontic or splint treatment;
  • (3) the prostheses have been removed due to failure or need further treatment;
  • (4) implant-supported prostheses in both mesial and distal sites;
  • (5) the adjacent teeth were directly or indirectly fixed with the implant-supported prosthesis;
  • (6) patients with missing clinical records of PD, PCR and BOP.
  • (7) The prosthetic prosthesis with implant-supported prosthesis was delivered for less than 3 months in Nanjing First Hospital.

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
Measure Description
Time Frame
the proximal contact surface was adjusted by a dental floss (Reach waxed dental floss from Johnson & Johnson, standard thickness)
Time Frame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
The degree of proximal contact loss(PCL) was evaluated with a dental floss passing through the contact areas and classified as: (a) tight: sufficient resistance to the passage of the floss; (b) loose: insufficient resistance to the passage of the floss; and (c) open: contact: no resistance to the passage of the floss. The presence of an open or loose contact was classified as PCL.
Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

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
Measure Description
Time Frame
oral panoramic radiograph
Time Frame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
Using the radiograph analysis software's measuring function, the amount of alveolar bone resorption of the implant as well as adjacent teeth was evaluated. (a)The original bone height was measured as the distance between the enamel-cemental junction and the root apex (or the implant neck edge and the implant base). (b)The existing bone height was measured as the distance between the top of the alveolar ridge to the root apex. (c) The height of alveolar bone resorption was calculated by subtracting the original bone height from the existing bone height.
Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
Bausch Arti-Fol R metallic Shimstock-Film
Time Frame: Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.
(a) Initial occlusal contact: Bausch articulating paper was applied to the restoration's occlusal surface, the patient was told to close their mouth slowly, the teeth just gently touched, and they opened their mouth right away. The paper was then removed, and the restoration's occlusal surface was examined to see if it had left a red mark. (b) Final occlusal contact: If the patient's restoration and opposing jaw teeth do not make contact during the initial occlusion, place the Bausch articulating paper on the restoration's occlusal surface, ask them to clench their teeth, and then have them open their mouth, take the paper out, and check to see if the implant's occlusal surface has any marks on it.
Patients with implant-supported prostheses reviewed 3 months after delivery were eligible for inclusion in this study.

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.
Nanjing First Hospital, Nanjing Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Changao Xue, Master, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Ning Luo, Master, The First Affiliated Hospital with Nanjing Medical University
  • Principal Investigator: Juan Lin, Master, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

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Study Major Dates

Study Start (Estimated)

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.
July 1, 2024

Primary Completion (Estimated)

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 30, 2024

Study Completion (Estimated)

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.
December 30, 2024

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).
June 20, 2024

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.
June 20, 2024

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.
June 26, 2024

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.
June 26, 2024

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.
June 20, 2024

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.
June 1, 2024

More Information

Terms related to this study

Keywords

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.
  • KY20240613-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Information about participants in this study will not be shared with investigators outside the study, and all study participants are identified by initials.

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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