Clincosm LogoSign in Get a demo

Immediate Implants in the Aesthetic Zone

Sponsor
Universidad de Murcia (Other)
Overall Status
Completed
CT.gov ID
NCT04343833
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
30.1
Actual Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Immediate dental implants
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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.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.
Masking:
Double (Participant, Investigator)
Masking Description:
Double (participant, investigator)
Primary Purpose:
Treatment
Official Title:
Primary Stability and PES/WES Evaluation for Immediate Implants in the Aesthetic Zone: a Clinical Double-blind Randomized Study
Actual Study Start Date :
Oct 2, 2017
Actual Primary Completion Date :
Jan 16, 2020
Actual Study Completion Date :
Apr 4, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Bone level [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.

    2. PES/WES [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medicine and Dentistry Faculty, Murcia University, Morales Meseguer Hospital Murcia Spain 30008

    Sponsors and Collaborators

    • Universidad de Murcia

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Arturo Sánchez-Pérez, Associate professor, Universidad de Murcia
    ClinicalTrials.gov Identifier:
    NCT04343833
    Other Study ID Numbers:
    • 2076/20018
    First Posted:
    Apr 13, 2020
    Last Update Posted:
    Apr 14, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Arturo Sánchez-Pérez, Associate professor, Universidad de Murcia
    Dental esthetics
    Primary stability
    Single-tooth restoration
    Osseointegration.

    Study Results

    No Results Posted as of Apr 14, 2020