Immediate Implants in the Aesthetic Zone

April 11, 2020 updated by: Arturo Sánchez-Pérez, Universidad de Murcia

Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

20 implants with two different designs (n=10) were immediately placed in the upper anterior maxilla with no grafting material. ISQ, BL, and PES/WES were evaluated. Results will analyze with the Wilcoxon-Mann-Whitney test (p<0.05).

The random distribution is made prior to assignment following the internet prgram https://www.random.org

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30008
        • Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Control with Standard dental implant
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
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.
Other Names:
  • Fresh extraction sockets
EXPERIMENTAL: Test with the new implant design
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
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.
Other Names:
  • Fresh extraction sockets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bone level
Time Frame: After 12 months of definitive implant load

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
Time Frame: After 12 months of definitive implant load
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 2, 2017

Primary Completion (ACTUAL)

January 16, 2020

Study Completion (ACTUAL)

April 4, 2020

Study Registration Dates

First Submitted

April 7, 2020

First Submitted That Met QC Criteria

April 9, 2020

First Posted (ACTUAL)

April 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 11, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2076/20018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Non-personal data

IPD Sharing Time Frame

Aftr the publication of the results

IPD Sharing Access Criteria

Any interested reseacher

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Immediate Dental Implant

Clinical Trials on Immediate dental implants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe