NCT04075383

Immediate and Early Single Dental Implants

Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Federal University of Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Single Tooth Lost
• Dental Implant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-22
• Primary completion: 2024-06-22
• Completion: 2024-06-22
• First posted: 2019-08-30
• Last updated: 2022-04-05

Locations

1 site across 1 country: Brazil