Immediate and Early Single Dental Implants

Federal University of Rio Grande do Sul

Status and phase: Enrolling; Phase 2

Conditions: Single Tooth Lost; Dental Implant

Treatments: Procedure: immediate-delayed dental implant; Procedure: immediate dental implant

Study type: Interventional

Funder types: Other

Identifiers

NCT04075383

11851319.9.0000.5347

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

120 participants in 2 patient groups

immediate dental implant

Other group

Description:

The implant is installed immediately after tooth extraction.

Treatment:

Procedure: immediate dental implant

immediate-delayed dental implant

Other group

Description:

The implant is installed 8 weeks after tooth extraction.

Treatment:

Procedure: immediate-delayed dental implant