Clinical trial NCT04075383: Immediate and Early Single Dental Implants
Official title: Immediate and Immediate-delayed Implants in the Esthetic Area: 12-months Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Single Tooth Lost
Dental Implant
Keywords: dental implant
esthetics
quality of life
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomised controlled parallel clinical trial
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: patient satisfaction: questionnaire
timeFrame: Up to 24 months
measure: tridimensional tissue changes
timeFrame: Up to 24 months
measure: Buccal bone level
timeFrame: Up to 24 months
Secondary outcomes:
measure: Pink esthetic score
timeFrame: Up to 24 months
measure: White esthetic score
timeFrame: Up to 24 months
measure: Implant failure
timeFrame: Up to 24 months
measure: Oral health related quality of life: OHIP-14
timeFrame: Up to 24 months
measure: dental plaque
timeFrame: Up to 24 months
measure: Pocket depth
timeFrame: Up to 24 months
measure: Bleeding
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Alex Haas
state: Rio Grande Do Sul
Study officials:
affiliation: Federal University of Rio Grande do Sul
name: Alex Haas, PhD
role: STUDY_DIRECTOR
References: