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NCT Number: NCT06006156

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

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.

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Key information

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad Nacional de Trujillo

Trujillo, La Libertad, 13001, Peru

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental implants placement

Procedure

surgery for placement of two one-piece trans gingival implants

Other names: implant supported prosthetic restoration

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

Secondary outcomes

  1. Plaque index

    Time frame: 1 year

    to score the plaque accumulation of plaque around implants will be used the Mombelli et al index

  2. Plaque index

    Time frame: 3 year

    to score the plaque accumulation of plaque around implants will be used the Mombelli et al index

  3. Bleeding on probing

    Time frame: 1 year

    During the probing, the bleeding on probing will be registered in the periodontal record.

  4. Bleeding on probing

    Time frame: 3 year

    During the probing, the bleeding on probing will be registered in the periodontal record.

  5. Probing depth

    Time frame: 1 year

    A calibrated probe will be used to measure the probing depth in all teeth annually.

  6. Probing depth

    Time frame: 3 year

    A calibrated probe will be used to measure the probing depth in all teeth annually.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

ARDEC Academy

Network

Collaborators

  • Universidad Nacional de Trujillo

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 23, 2023
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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