Immediate and Early Single Dental Implants

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implant; Single Tooth Lost
• Intervention / Treatment: Procedure: immediate dental implant; Procedure: immediate-delayed dental implant

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Alex Haas, PhD; Phone Number: 555133085318; Email: alexnhaas@gmail.com

Study Locations

• Brazil
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90630080
      • Recruiting
      • Alex Haas
      • Contact: Alex N Haas; Phone Number: 555191222377; Email: alexnhaas@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: immediate dental implant; The implant is installed immediately after tooth extraction.	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.
Other: immediate-delayed dental implant; The implant is installed 8 weeks after 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Rio Grande do Sul
• Investigators: Study Director: Alex Haas, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2019
• Primary Completion (Anticipated): June 22, 2024
• Study Completion (Anticipated): June 22, 2024

Study Registration Dates

• First Submitted: June 27, 2019
• First Submitted That Met QC Criteria: August 28, 2019
• First Posted (Actual): August 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2022
• Last Update Submitted That Met QC Criteria: April 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: quality of life; dental implant; esthetics
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Tooth Loss
• Other Study ID Numbers: 11851319.9.0000.5347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No