Dental Implant, Single Tooth Lost
Conditions
Keywords
dental implant, esthetics, quality of life
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.
Interventions
PROCEDUREimmediate dental implant
Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.
PROCEDUREimmediate-delayed dental implant
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
Sponsors
Federal University of Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Researchers involved in the assessment of all outcomes will be not aware of the randomisation
Intervention model description
randomised controlled parallel clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| patient satisfaction: questionnaire | Up to 24 months | satisfaction with treatments by questionnaire in a VAS scale |
| tridimensional tissue changes | Up to 24 months | 3D measurements obtained in oral scanning |
| Buccal bone level | Up to 24 months | CBCT analysis of the buccal bone |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral health related quality of life: OHIP-14 | 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 | Up to 24 months | Plaque accumulation at the crowns |
| Pink esthetic score | 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 |
| Bleeding | Up to 24 months | Bleeding after probing |
| Pocket depth | Up to 24 months | Measured in millimetres |
| White esthetic score | 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 | Up to 24 months | Failure defined as loss of implant |
Countries
Brazil
Contacts
Primary ContactAlex Haas, PhD
Outcome results
None listed