Immediate and Early Single Dental Implants

Phase 2

• Conditions: Single Tooth Lost; Dental Implant
• Interventions: Procedure: immediate dental implant; Procedure: immediate-delayed dental implant

• Registration Number: NCT04075383
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-22
• Study First Submitted: 2019-06-27
• Study First Submitted QC: 2019-08-28
• Study First Posted: 2019-08-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-02
• Last Update Posted: 2022-04-05
• Primary Completion: 2024-06-22
• Study Completion: 2024-06-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immediate dental implant	immediate dental implant	The implant is installed immediately after tooth extraction.
immediate-delayed dental implant	immediate-delayed dental implant	The implant is installed 8 weeks after tooth extraction.

Primary Outcome Measures

Name	Time	Method
tridimensional tissue changes	Up to 24 months	3D measurements obtained in oral scanning
Buccal bone level	Up to 24 months	CBCT analysis of the buccal bone
patient satisfaction: questionnaire	Up to 24 months	satisfaction with treatments by questionnaire in a VAS scale

Secondary Outcome Measures

Name	Time	Method
Oral health related quality of life: OHIP-14	Up to 24 months	Questionnaire assessing 14 questions of quality of life in a likert scale summing up a total of 48 points
Implant failure	Up to 24 months	Failure defined as loss of implant
White esthetic score	Up to 24 months	Evaluation of the clinical esthetic outcome of prosthetic crowns recorded from 0 to 2, summing up a total of 14 points
dental plaque	Up to 24 months	Plaque accumulation at the crowns
Bleeding	Up to 24 months	Bleeding after probing
Pink esthetic score	Up to 24 months	Evaluation of the clinical esthetic outcome of soft tissues in 7 parameters recorded from 0 to 2, summing up a total of 14 points
Pocket depth	Up to 24 months	Measured in millimetres

Trial Locations

Locations (1)

Alex Haas; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil