Immediate Implants in the Aesthetic Zone

NCT04343833 | Completed DMC

• 1 other identifier: 2076/20018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The use of immediate implants in the aesthetic area is a technique widely used in modern implantology. The characteristics of the patient, the implant, and the surgical procedure used may influence the final results. The aim was to assess whether the implant design affects primary (PS) and secondary stability (SS), bone level (BL), and PES/WES evaluation.

Conditions

Immediate Dental Implant

Keywords

Dental esthetics; Primary stability; Single-tooth restoration; Osseointegration.

Outcome Measures

Primary Outcomes (2)

• Bone level

  The bone level (BL) was determined by an intraoral digital radiograph taken parallel to the long axis of the implant. The distance from the implant neck to the first contact between the bone and the implant was determined. It was measured in both sides, mesial and distal, and the mean between both values was established as the BL value.

  After 12 months of definitive implant load

• PES/WES

  Pink Esthetic Score/White Esthetic Score \[PES/WES\] The parameters evaluated by this index are (1) mesial papilla, (2) distal papilla, (3) curvature of facial mucosa, (4) level of facial mucosa, and (5) root convexity/soft tissue color and texture. Each parameter range between 0 and 2. A maximum score of 10 can be obtained, considering acceptable from 6 The WES focuses specifically on the visible part of the restoration and in base on the following five parameters: (1) tooth form, (2) tooth volume/outline, (3) color (hue and value), (4) Surface texture, and (5) translucency. Each parameter is evaluated by comparison with the adjacent teeth, giving a value ranged from 0 to 2. A total score of 10 can be obtained, considering acceptable from 6

  After 12 months of definitive implant load

Study Arms (2)

Control with Standard dental implant

ACTIVE COMPARATOR

Patients were treated with implants Inhex Ticare Standard (Mozo Grau, Ticare, Valladolid, Spain). The implants presented a surface treated with Reabsorbable Blast Media (RBM), conical macro-design with non-aggressive threads, internal connection, and platform switching. On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.

Procedure: Immediate dental implants

Test with the new implant design

EXPERIMENTAL

Patients were treated with Implants Inhex Quattro Ticare (Mozo Grau, Ticare, Valladolid, Spain). The implants also presented a surface treated with RBM, conical macro-design with expanded micro threads, internal connection, and platform switching.On the implant shoulder, the beveled design of the platform was characterized by a rounded shape of 45º.

Procedure: Immediate dental implants

Interventions

Immediate dental implants PROCEDURE

At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.

Also known as: Fresh extraction sockets

Control with Standard dental implant; Test with the new implant design

Eligibility Criteria

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

You may qualify if:

• Patients who presented aa vertical fracture in an upper incisor that can not be treated conservatively and ended in the extraction, and the treatment needed is a unitary implant.
• Good systemic health status (ASA I or II).
• Oral hygiene index of \< 2 (Löe and Silness).
• A minimum of 2 mm of attached mucosa.
• A minimum of 8 mm of vertical bone.
• A minimum of 7 mm of bucco-lingual bone.

You may not qualify if:

• Traumatic or complicated incisor extraction.
• Pregnant or women in the lactation period.
• Use of any medication that contraindicates implant treatment.
• A history of alcohol or drug abuse.
• A requirement for guided bone regeneration.
• A requirement for tissue graft augmentation.
• Failure to comply with the study protocol.

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital

Murcia, 30008, Spain

Location

Related Publications (1)

• Sanchez-Perez A, Nicolas-Silvente AI, Sanchez-Matas C, Molina-Garcia S, Navarro-Cuellar C, Romanos GE. Primary stability and PES/WES evaluation for immediate implants in the aesthetic zone: a pilot clinical double-blind randomized study. Sci Rep. 2021 Oct 8;11(1):20024. doi: 10.1038/s41598-021-99218-8.

  PMID: 34625591 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double (participant, investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: A total of 20 patients, distributed in two groups with ten patient each (experimental and control) were included in this study. All patients signed a double informed consent, one for implant placement and one for their participation in the study. The study follows the Declaration of Helsinki recommendations. The Ethics Committee of the University of Murcia approved the study protocol with ID: 2076/2018.

Study Record Dates

• First Submitted: April 7, 2020
• First Posted: April 13, 2020
• Study Start: October 2, 2017
• Primary Completion: January 16, 2020
• Study Completion: April 4, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Aftr the publication of the results
• Access Criteria: Any interested reseacher

Locations

ES (1)