Immediate and Early Single Dental Implants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-22

Study Completion Date

2024-06-22

Brief Summary

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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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Detailed Description

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Conditions

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Single Tooth Lost Dental Implant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

randomised controlled parallel clinical trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Researchers involved in the assessment of all outcomes will be not aware of the randomisation

Study Groups

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immediate dental implant

The implant is installed immediately after tooth extraction.

Group Type OTHER

immediate dental implant

Intervention Type PROCEDURE

Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.

immediate-delayed dental implant

The implant is installed 8 weeks after tooth extraction.

Group Type OTHER

immediate-delayed dental implant

Intervention Type PROCEDURE

Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.

Interventions

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immediate dental implant

Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.

Intervention Type PROCEDURE

immediate-delayed dental implant

Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes