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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

Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE August 30, 2019
Last Update Posted Date October 1, 2019
Actual Study Start Date  ICMJE June 22, 2019
Estimated Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • patient satisfaction: questionnaire [ Time Frame: Up to 24 months ]
    satisfaction with treatments by questionnaire in a VAS scale
  • tridimensional tissue changes [ Time Frame: Up to 24 months ]
    3D measurements obtained in oral scanning
  • Buccal bone level [ Time Frame: Up to 24 months ]
    CBCT analysis of the buccal bone
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • patient satisfaction: questionnaire [ Time Frame: Up to 24 months ]
    satisfaction with treatments by questionnaire
  • tridimensional tissue changes [ Time Frame: Up to 24 months ]
    3D measurements obtained in oral scanning
  • Buccal bone level [ Time Frame: Up to 24 months ]
    CBCT analysis of the buccal bone
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2019)
  • 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
  • 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
  • Implant failure [ Time Frame: Up to 24 months ]
    Failure defined as loss of implant
  • 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
  • dental plaque [ Time Frame: Up to 24 months ]
    Plaque accumulation at the crowns
  • Pocket depth [ Time Frame: Up to 24 months ]
    Measured in millimetres
  • Bleeding [ Time Frame: Up to 24 months ]
    Bleeding after probing
Original Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2019)
  • Pink esthetic score [ Time Frame: Up to 24 months ]
    Evaluation of the clinical esthetic outcome of soft tissues.
  • White esthetic score [ Time Frame: Up to 24 months ]
    Evaluation of the clinical esthetic outcome of prosthetic crowns
  • Implant failure [ Time Frame: Up to 24 months ]
    Failure defined as loss of implant
  • Oral health related quality of life: OHIP-14 [ Time Frame: Up to 24 months ]
    OHIP-14
  • dental plaque [ Time Frame: Up to 24 months ]
    Plaque accumulation at the crowns
  • Pocket depth [ Time Frame: Up to 24 months ]
    Measured in millimetres
  • Bleeding [ Time Frame: Up to 24 months ]
    Bleeding after probing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate and Early Single Dental Implants
Official Title  ICMJE Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Single Tooth Lost
  • Dental Implant
Intervention  ICMJE
  • 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.
  • Procedure: immediate-delayed dental implant
    Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
Study Arms  ICMJE
  • immediate dental implant
    The implant is installed immediately after tooth extraction.
    Intervention: Procedure: immediate dental implant
  • immediate-delayed dental implant
    The implant is installed 8 weeks after tooth extraction.
    Intervention: Procedure: immediate-delayed dental implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 28, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 22, 2023
Estimated Primary Completion Date June 22, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alex Haas, PhD 555133085318 alexnhaas@gmail.com
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04075383
Other Study ID Numbers  ICMJE 11851319.9.0000.5347
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Alex Nogueira Haas, Federal University of Rio Grande do Sul
Study Sponsor  ICMJE Federal University of Rio Grande do Sul
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alex Haas, PhD Federal University of Rio Grande do Sul
PRS Account Federal University of Rio Grande do Sul
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP