Immediate and Early Single Dental Implants

Study Overview
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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.

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

Conditions
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Single Tooth Lost, Dental Implant

Intervention / Treatment
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* Procedure: immediate dental implant
* Procedure: immediate-delayed dental implant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomised controlled parallel clinical trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: immediate dental implant<br>The implant is installed immediately after tooth extraction. | Procedure: immediate dental implant<br>* Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.<br>|
| Other: immediate-delayed dental implant<br>The implant is installed 8 weeks after tooth extraction. | Procedure: immediate-delayed dental implant<br>* Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dental implant, esthetics, quality of life