Immediate and Early Single Dental Implants

NCT04075383 | Unknown Phase 2

• 1 other identifier: 11851319.9.0000.5347
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Single Tooth Lost; Dental Implant

Keywords

dental implant; esthetics; quality of life

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Pink esthetic score

  Up to 24 months

• White esthetic score

  Up to 24 months

• Implant failure

  Up to 24 months

• Oral health related quality of life: OHIP-14

  Up to 24 months

• dental plaque

  Up to 24 months

Study Arms (2)

immediate dental implant

OTHER

The implant is installed immediately after tooth extraction.

Procedure: immediate dental implant

immediate-delayed dental implant

OTHER

The implant is installed 8 weeks after tooth extraction.

Procedure: immediate-delayed dental implant

Interventions

immediate dental implant PROCEDURE

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

immediate dental implant

immediate-delayed dental implant PROCEDURE

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

immediate-delayed dental implant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Rio Grande do Sul: lead

Study Sites (1)

Alex Haas

Porto Alegre, Rio Grande do Sul, 90630080, Brazil

RECRUITING

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, Endosseous; Dental Implantation; Oral Surgical Procedures, Preprosthetic; Oral Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Dentistry; Prosthodontics

Study Officials

• Alex Haas, PhD

  Federal University of Rio Grande do Sul

  STUDY DIRECTOR

Central Study Contacts

Alex Haas, PhD

CONTACT

555133085318; alexnhaas@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Researchers involved in the assessment of all outcomes will be not aware of the randomisation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: randomised controlled parallel clinical trial

Study Record Dates

• First Submitted: June 27, 2019
• First Posted: August 30, 2019
• Study Start: June 22, 2019
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)