SA Versus SOI Surfaces for Single Implant-supported Crown

Last updated: September 29, 2019
Sponsor: Osstem AIC
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bone Density

Treatment

N/A

Clinical Study ID

NCT04073654
SOI_1_RCT_MT
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this randomized controlled trial is to compare clinical data and implant stability of immediately loaded TSIII Osstem implants with Sandblasted and Acid-etched (SA) surface versus implants with SA surface modified with pH buffering agent for the rehabilitation of single implant-supported crown.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Any partially edentulous subject requiring at least two single (preferablenon-adjacent) implant-supported crowns, being at least 18 year old and able to sign aninformed consent will be screened for eligibility. Bone volumes should allow theplacement of two implants at least 8.5 mm (maximum 10 mm) long and 4.5 mm (minimum 3.5mm) wide, with a minimal insertion torque of 30 Ncm. Implants can be placed inprevious post-extractive socket or in augmented bone, if at least 4 to 6 months havepassed from the extraction or from augmentation procedures.

Exclusion

Exclusion Criteria:

  • Patients unable to commit to 5 years follow-up.

  • General contraindications to implant surgery.

  • Less then 4 mm of keratinised gingiva crestally (at the implant sites).

  • Immune-suppressed/compromised patients.

  • Patients irradiated in the head and/or neck.

  • Uncontrolled diabetes.

  • Pregnancy or lactation.

  • Untreated periodontal disease.

  • Poor oral hygiene and motivation (full mouth bleeding and full mouth plaque indexhigher than 25%).

  • Addiction to alcohol or drugs.

  • Psychiatric problems and/or unrealistic expectations.

  • Patients with an acute infection or suppuration in the site intended for implantplacement.

  • Patients needing any form of tissue augmentation at implant placement.

  • Immediate post-extractive implants (implants can be placed after a 3-month healingperiod).

  • Patients treated or under treatment with intravenous amino-bisphosphonates.

  • Patients referred only for implant placement if the follow-up cannot be done at thetreatment center.

  • Patients participating in other studies, if the present protocol could not be fullyadhered to.

Study Design

Total Participants: 100
Study Start date:
September 26, 2019
Estimated Completion Date:
October 15, 2021

Study Description

This study aimed to evaluate if there are some benefits using novel implant surface. This surface should improve the secondary implant stability, reducing the overall time needed for the osseointegration. main benefits in clinical practice should be reduced treatment time.

Connect with a study center

  • Erta Xhanari

    Tirana,
    Albania

    Active - Recruiting

  • Elitsa Deliverska

    Sofia,
    Bulgaria

    Active - Recruiting

  • Fulvio Gatti

    Milan,
    Italy

    Active - Recruiting

  • Studio Odontoiatrico Marco Tallarico

    Rome, 00151
    Italy

    Active - Recruiting

  • Leonardo Muzzi

    Siena,
    Italy

    Active - Recruiting

  • Łukasz Zadrożny

    Warsaw,
    Poland

    Active - Recruiting

  • Cesaltino Remedios

    Fatima,
    Portugal

    Active - Recruiting

  • Mircea

    Craiova,
    Romania

    Active - Recruiting

  • Andre de Waal

    South Africa,
    South Africa

    Active - Recruiting

  • Nicolas Widmer

    Bern,
    Switzerland

    Active - Recruiting

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