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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
120
Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
Alex Haas
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGpatient satisfaction: questionnaire
satisfaction with treatments by questionnaire in a VAS scale
Time frame: Up to 24 months
tridimensional tissue changes
3D measurements obtained in oral scanning
Time frame: Up to 24 months
Buccal bone level
CBCT analysis of the buccal bone
Time frame: Up to 24 months
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
Time frame: 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
Time frame: Up to 24 months
Implant failure
Failure defined as loss of implant
Time frame: 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
Time frame: Up to 24 months
dental plaque
Plaque accumulation at the crowns
Time frame: Up to 24 months
Pocket depth
Measured in millimetres
Time frame: Up to 24 months
Bleeding
Bleeding after probing
Time frame: Up to 24 months
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