Dimensional Changes in Single Crowns Supported by Short Transmucosal Implants With Diverging or Converging Neck Profiles in the Esthetic Zone

December 9, 2023 updated by: ARDEC Academy

Long-term Dimensional Changes in Single Crowns Supported by Short (6 mm) Transmucosal Implants With Divergent or Convergent Neck Profiles in the Esthetic Zone. A Randomized Randomized Controlled Clinical Trial

The goal of the present randomized clinical trial is to assess the long-term osseous and peri-implant soft tissue changes as well as the success rate of short implants (6 mm) with a converging collar with micro threads or a diverging polished collar placed in the esthetic zone of the maxilla on partially edentulous patients. The main questions it aims to answer are:

  • what are the long-term bone and soft tissue changes around implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla?
  • What is the success rate of implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla? Dental implants with a converging collar with micro threads or a diverging polished collar will be placed in the esthetic zone of the maxilla of the included participants and the measurements regarding the bone and soft tissue level will be compared.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objectives of the present randomized clinical trial are to evaluate the clinical and radiographic changes over time of hard and soft tissues around implants with a convergent or divergent collar. Twenty volunteer participants with two edentulous regions in the maxillary esthetic zone (from the right second premolar to the left second premolar) will be included in the study. Two implants will be randomly installed, one with a convergent collar and one with a divergent collar. After 3 months of healing, individual crowns will be installed. At each visit the following parameters will be evaluated: plaque index, probing depth, bleeding on probing, the recession of the mucosal margin, intraoral radiographs, likewise control CBCT, and impressions will be performed. The visit will take place at 6 and 12 months and then annually for a minimum of 3 years. Changes at the level of the marginal bone will be assessed overtime on the radiographs. Dimensional changes will be clinically evaluated during control evaluations and later through digital impressions.

Study Type

Interventional

Enrollment (Estimated)

20

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 Contact

Study Contact Backup

Study Locations

  • Peru
    • La Libertad
      • Trujillo, La Libertad, Peru, 13001
        • Recruiting
        • Universidad Nacional de Trujillo
        • Contact:

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Presence of at least two edentulous areas in the esthetic region of the maxilla (from right to left from second premolar to premolar, preferably first premolars and incisors)
  • Alveolar bone ≥ 8 mm in height and ≥ 5 mm in thickness assessed on CBCT.
  • Age of ≥ 21 years.
  • Need for an implant-supported prosthetic restoration.
  • Be in good general health with no contraindications to oral surgical procedures.
  • Not be pregnant.
  • Patients who agree to participate in the study and sign the informed consent.

Exclusion Criteria:

  • The presence of any uncontrolled systemic disease.
  • History of past or ongoing chemotherapeutic or radiotherapeutic treatments.
  • Heavy smokers (>10 cigarettes per day).
  • Previous bone regeneration procedures in the area of interest

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dental implant with a convergent collar
One implant with a converging collar with micro threads will be installed in each patient according to the site randomization in the esthetic region of the upper jaw (between the second premolars).
Procedure: Dental implants placement
surgery for placement of two one-piece trans gingival implants
Other Names:
  • implant supported prosthetic restoration
Active Comparator: dental implant with a divergent collar
One implant with a diverging polished collar will be installed in each patient according to the site randomization in the esthetic region of the upper jaw ( between the second premolars).
Procedure: Dental implants placement
surgery for placement of two one-piece trans gingival implants
Other Names:
  • implant supported prosthetic restoration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
height of the periimplant bone tissues
Time Frame: baseline
The height of the periimplant bone tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints
baseline
height of the periimplant bone tissues
Time Frame: 3 years follow up
The height of the periimplant bone tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints
3 years follow up
height of the periimplant soft tissues
Time Frame: Baseline
The height of the periimplant soft tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints
Baseline
height of the periimplant soft tissues
Time Frame: 3 years follow up
The height of the periimplant soft tissues will be evaluated in the intraoral radiographic images, cone beam tomography, and the three-dimensional images obtained from the digital prints
3 years follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: 1 year
to score the plaque accumulation of plaque around implants will be used the Mombelli et al index
1 year
Plaque index
Time Frame: 3 year
to score the plaque accumulation of plaque around implants will be used the Mombelli et al index
3 year
Bleeding on probing
Time Frame: 1 year
During the probing, the bleeding on probing will be registered in the periodontal record.
1 year
Bleeding on probing
Time Frame: 3 year
During the probing, the bleeding on probing will be registered in the periodontal record.
3 year
Probing depth
Time Frame: 1 year
A calibrated probe will be used to measure the probing depth in all teeth annually.
1 year
Probing depth
Time Frame: 3 year
A calibrated probe will be used to measure the probing depth in all teeth annually.
3 year
Implant success rate
Time Frame: 1 year
The criteria to evaluate the success rate will be if there was no persistent and/or irreversible signs or symptoms such as pain, infection, neuropathies, or paresthesia, no peri-implant infection with suppuration, no mobility, and no continuous radiolucency around the implant.
1 year
Implant success rate
Time Frame: 3 years
The criteria to evaluate the success rate will be if there was no persistent and/or irreversible signs or symptoms such as pain, infection, neuropathies, or paresthesia, no peri-implant infection with suppuration, no mobility, and no continuous radiolucency around the implant.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ARDEC Academy

Collaborators

Universidad Nacional de Trujillo

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

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, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

April 5, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Estimated)

December 15, 2023

Last Update Submitted That Met QC Criteria

December 9, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UNT_short implants

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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