Immediate and Early Single Dental Implants
Primary Purpose
Single Tooth Lost, Dental Implant
Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
immediate dental implant
immediate-delayed dental implant
Sponsored by
About this trial
This is an interventional treatment trial for Single Tooth Lost focused on measuring dental implant, esthetics, quality of life
Eligibility 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.
Sites / Locations
- Alex HaasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
immediate dental implant
immediate-delayed dental implant
Arm Description
The implant is installed immediately after tooth extraction.
The implant is installed 8 weeks after tooth extraction.
Outcomes
Primary Outcome Measures
patient satisfaction: questionnaire
satisfaction with treatments by questionnaire in a VAS scale
tridimensional tissue changes
3D measurements obtained in oral scanning
Buccal bone level
CBCT analysis of the buccal bone
Secondary Outcome Measures
Pink esthetic score
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
Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points
Implant failure
Failure defined as loss of implant
Oral health related quality of life: OHIP-14
Questionnaire assessing 14 questions of quality of life in a likert scale summing up a total of 48 points
dental plaque
Plaque accumulation at the crowns
Pocket depth
Measured in millimetres
Bleeding
Bleeding after probing
Full Information
NCT ID
NCT04075383
First Posted
June 27, 2019
Last Updated
April 2, 2022
Sponsor
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT04075383
Brief Title
Immediate and Early Single Dental Implants
Official Title
Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2019 (Actual)
Primary Completion Date
June 22, 2024 (Anticipated)
Study Completion Date
June 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Rio Grande do Sul
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Tooth Lost, Dental Implant
Keywords
dental implant, esthetics, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
randomised controlled parallel clinical trial
Masking
Outcomes Assessor
Masking Description
Researchers involved in the assessment of all outcomes will be not aware of the randomisation
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate dental implant
Arm Type
Other
Arm Description
The implant is installed immediately after tooth extraction.
Arm Title
immediate-delayed dental implant
Arm Type
Other
Arm Description
The implant is installed 8 weeks after tooth extraction.
Intervention Type
Procedure
Intervention Name(s)
immediate dental implant
Intervention Description
Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.
Intervention Type
Procedure
Intervention Name(s)
immediate-delayed dental implant
Intervention Description
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
Primary Outcome Measure Information:
Title
patient satisfaction: questionnaire
Description
satisfaction with treatments by questionnaire in a VAS scale
Time Frame
Up to 24 months
Title
tridimensional tissue changes
Description
3D measurements obtained in oral scanning
Time Frame
Up to 24 months
Title
Buccal bone level
Description
CBCT analysis of the buccal bone
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Pink esthetic score
Description
Evaluation of the clinical esthetic outcome of soft tissues in 7 parameters recorded from 0 to 2, summing up a total of 14 points
Time Frame
Up to 24 months
Title
White esthetic score
Description
Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points
Time Frame
Up to 24 months
Title
Implant failure
Description
Failure defined as loss of implant
Time Frame
Up to 24 months
Title
Oral health related quality of life: OHIP-14
Description
Questionnaire assessing 14 questions of quality of life in a likert scale summing up a total of 48 points
Time Frame
Up to 24 months
Title
dental plaque
Description
Plaque accumulation at the crowns
Time Frame
Up to 24 months
Title
Pocket depth
Description
Measured in millimetres
Time Frame
Up to 24 months
Title
Bleeding
Description
Bleeding after probing
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alex Haas, PhD
Phone
555133085318
Email
alexnhaas@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Haas, PhD
Organizational Affiliation
Federal University of Rio Grande do Sul
Official's Role
Study Director
Facility Information:
Facility Name
Alex Haas
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90630080
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alex N Haas
Phone
555191222377
Email
alexnhaas@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Immediate and Early Single Dental Implants
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