Universidad Nacional de Trujillo
Trujillo, La Libertad, 13001, Peru
NCT Number: NCT06006156
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.
This study is active but is not currently recruiting participants.
Notify Me21 year–60 year
All sexes
Interventional
Not applicable
Trujillo, La Libertad, 13001, Peru
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
surgery for placement of two one-piece trans gingival implants
Other names: implant supported prosthetic restoration
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
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
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
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
Time frame: 1 year
to score the plaque accumulation of plaque around implants will be used the Mombelli et al index
Time frame: 3 year
to score the plaque accumulation of plaque around implants will be used the Mombelli et al index
Time frame: 1 year
During the probing, the bleeding on probing will be registered in the periodontal record.
Time frame: 3 year
During the probing, the bleeding on probing will be registered in the periodontal record.
Time frame: 1 year
A calibrated probe will be used to measure the probing depth in all teeth annually.
Time frame: 3 year
A calibrated probe will be used to measure the probing depth in all teeth annually.
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.
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.
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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
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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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