Immediate and Early Single Dental Implants

Dental Implant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04075383
• Other study ID #: 11851319.9.0000.5347
• Status: Recruiting
• Phase: Phase 2
• Start date: June 22, 2019
• Est. completion date: June 22, 2024

Study information

• Verified date: April 2022
• Source: Federal University of Rio Grande do Sul
• Contact: Alex Haas, PhD
• Phone: 555133085318
• Email: alexnhaas[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 22, 2024
• Est. primary completion date: June 22, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Implant
• Single Tooth Lost
• Tooth Loss

Intervention

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.
• immediate-delayed dental implant
Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.

Locations

Country	Name	City	State
Brazil	Alex Haas	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient satisfaction: questionnaire	satisfaction with treatments by questionnaire in a VAS scale	Up to 24 months
Primary	tridimensional tissue changes	3D measurements obtained in oral scanning	Up to 24 months
Primary	Buccal bone level	CBCT analysis of the buccal bone	Up to 24 months
Secondary	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
Secondary	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
Secondary	Implant failure	Failure defined as loss of implant	Up to 24 months
Secondary	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
Secondary	dental plaque	Plaque accumulation at the crowns	Up to 24 months
Secondary	Pocket depth	Measured in millimetres	Up to 24 months
Secondary	Bleeding	Bleeding after probing	Up to 24 months