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Immediate and Early Single Dental Implants

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ClinicalTrials.gov Identifier: NCT04075383
Recruitment Status : Recruiting
First Posted : August 30, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Alex Nogueira Haas, Federal University of Rio Grande do Sul

Brief Summary:
The objective of the research project will be to compare immediate and early unitary implants for the rehabilitation of missing teeth in the upper aesthetic region. A randomized controlled trial will be conducted in parallel with 120 individuals (60 per group) who are above 18 years of age, periodontally healthy, and who need to perform only one unit implant in the upper aesthetic region between the second premolars. In the immediate implant group, the tooth will be extracted in a minimally traumatic manner and the implant will be installed immediately after the fresh alveolus. Bovine bone replacement will be inserted into the gap between implant and vestibular wall of the alveolus, and an immediate temporary will be installed immediately. The provisional will be maintained for 3 months when the definitive crown will be made. In the early implant group, the tooth will be extracted, and after 2 months the implant will be installed with the use of bovine bone substitute to restore the buccal bone contour. The implant will be submerged, and 3 months of osseointegration will be performed reopening and final crown making. In both groups, the individuals will be followed for 1 year after the installation of the definitive crown. The outcomes evaluated will be patient satisfaction (main outcome), gingival phenotype, visible plaque, depth of probing, submucosal bleeding, proximal radiographic bone level, tomographic vestibular bone volume, perimplant clinical aesthetic indexes (Esthetic Pink Score and Papillary Index), evaluation three-dimensional tissue from intra-oral scanning and 3D printing, implant-related quality of life, and early and late implantation failures. Linear and logistic models of generalized estimating equations that take into account the longitudinal character of the study will be used for data analysis.

Condition or disease Intervention/treatment Phase
Single Tooth Lost Dental Implant Procedure: immediate dental implant Procedure: immediate-delayed dental implant Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomised controlled parallel clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Researchers involved in the assessment of all outcomes will be not aware of the randomisation
Primary Purpose: Treatment
Official Title: Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
Actual Study Start Date : June 22, 2019
Estimated Primary Completion Date : June 22, 2022
Estimated Study Completion Date : June 22, 2023

Arm Intervention/treatment
immediate dental implant
The implant is installed immediately after tooth extraction.
Procedure: immediate dental implant
Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.

immediate-delayed dental implant
The implant is installed 8 weeks after tooth extraction.
Procedure: immediate-delayed dental implant
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.




Primary Outcome Measures :
  1. patient satisfaction: questionnaire [ Time Frame: Up to 24 months ]
    satisfaction with treatments by questionnaire in a VAS scale

  2. tridimensional tissue changes [ Time Frame: Up to 24 months ]
    3D measurements obtained in oral scanning

  3. Buccal bone level [ Time Frame: Up to 24 months ]
    CBCT analysis of the buccal bone


Secondary Outcome Measures :
  1. Pink esthetic score [ Time Frame: Up to 24 months ]
    Evaluation of the clinical esthetic outcome of soft tissues in 7 parameters recorded from 0 to 2, summing up a total of 14 points

  2. White esthetic score [ Time Frame: Up to 24 months ]
    Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points

  3. Implant failure [ Time Frame: Up to 24 months ]
    Failure defined as loss of implant

  4. Oral health related quality of life: OHIP-14 [ Time Frame: Up to 24 months ]
    Questionnaire assessing 14 questions of quality of life in a likert scale summing up a total of 48 points

  5. dental plaque [ Time Frame: Up to 24 months ]
    Plaque accumulation at the crowns

  6. Pocket depth [ Time Frame: Up to 24 months ]
    Measured in millimetres

  7. Bleeding [ Time Frame: Up to 24 months ]
    Bleeding after probing



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients above 18 years old who require only one single implant in the upper aesthetic area between the second premolars will be included.
  • The region from which the tooth will be extracted should have bone quality and quantity compatible with implant placement with a minimum diameter and length of 3.0 mm and 8.0 mm, respectively.

Exclusion Criteria:

  • Who present compromise immunology of any nature;
  • Who have been exposed to head and neck radiotherapy;
  • Who have uncontrolled diabetes (glycated hemoglobin above 6.5 mg/dL);
  • Who present active periodontitis, defined by the presence of bleeding on probing >10% and probing depth and clinical attachment loss > 4mm;
  • Who have performed or are being treated with intravenous bisphosphonates.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075383


Contacts
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Contact: Alex Haas, PhD 555133085318 alexnhaas@gmail.com

Locations
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Brazil
Alex Haas Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90630080
Contact: Alex N Haas    555191222377    alexnhaas@gmail.com   
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Study Director: Alex Haas, PhD Federal University of Rio Grande do Sul
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Responsible Party: Alex Nogueira Haas, Associate Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT04075383    
Other Study ID Numbers: 11851319.9.0000.5347
First Posted: August 30, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alex Nogueira Haas, Federal University of Rio Grande do Sul:
dental implant
esthetics
quality of life
Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases