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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| immediate dental implant | Other | The implant is installed immediately after tooth extraction. |
|
| immediate-delayed dental implant | Other | The implant is installed 8 weeks after tooth extraction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| immediate dental implant | Procedure | Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| patient satisfaction: questionnaire | satisfaction with treatments by questionnaire in a VAS scale | Up to 24 months |
| tridimensional tissue changes | 3D measurements obtained in oral scanning | Up to 24 months |
| Buccal bone level | CBCT analysis of the buccal bone | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 24 months |
| White esthetic score | Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alex Haas, PhD | Contact | 555133085318 | alexnhaas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Alex Haas, PhD | Federal University of Rio Grande do Sul | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alex Haas | Recruiting | Porto Alegre | Rio Grande do Sul | 90630080 | Brazil |
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| ID | Term |
|---|---|
| D057893 | Immediate Dental Implant Loading |
| ID | Term |
|---|---|
| D003758 | Dental Implantation, Endosseous |
| D003757 | Dental Implantation |
| D013516 | Oral Surgical Procedures, Preprosthetic |
| D019647 | Oral Surgical Procedures |
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randomised controlled parallel clinical trial
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Researchers involved in the assessment of all outcomes will be not aware of the randomisation
| immediate-delayed dental implant | Procedure | Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction. |
|
| Up to 24 months |
| Implant failure | Failure defined as loss of implant | Up to 24 months |
| 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 | Up to 24 months |
| dental plaque | Plaque accumulation at the crowns | Up to 24 months |
| Pocket depth | Measured in millimetres | Up to 24 months |
| Bleeding | Bleeding after probing | Up to 24 months |
| D013514 | Surgical Procedures, Operative |
| D019919 | Prosthesis Implantation |
| D003813 | Dentistry |
| D011476 | Prosthodontics |