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Clinical Evaluation of Implant-secured Removable Partial Denture (PASI-PAC)

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ClinicalTrials.gov Identifier: NCT02762201
Recruitment Status : Recruiting
First Posted : May 4, 2016
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
This study aims to compare the therapeutic efficiency of implant-secured removable partial denture (PASI) with the therapeutic efficiency of the metalic standard removable partial denture (PAC) in the treatment of intermediate extended-gap (4 adjacent teeth). The therapeutic efficiency will be assessed by the 5 years-prosthetic success rate.

Condition or disease Intervention/treatment Phase
Tooth Loss Procedure: PASI Procedure: PAC Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Therapeutic Efficiency of Implant-secured Removable Partial Denture: A Randomized, Controlled, Prospective Multicentric Study.
Actual Study Start Date : May 16, 2014
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: PASI
PASI dental prosthesis delivery
Procedure: PASI

Implant-secured removable partial denture will be delivered in 2 large steps: implant delivery followed by denture delivery.

  • Implant delivery will take 4 dental consultations : a pre-implant study at Day14 after inclusion, the surgical implant insertion at D28 after inclusion, stitches removal at D35 after inclusion, and finally functional implant delivery between 3 or 6 month after surgery (to allow implant osteointegration).
  • Denture delivery will take 6 weekly dental consultations between Week 3 and Week 8 after the functional implant delivery.

Active Comparator: PAC
PAC dental prosthesis delivery
Procedure: PAC
Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.




Primary Outcome Measures :
  1. prosthetic success rate [ Time Frame: 5 years after prosthesis delivery ]

Secondary Outcome Measures :
  1. prosthetic success rate [ Time Frame: 6 months, 1 year, 2 years, 3 years and 4 years after prosthesis delivery ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with at least a 4 to 6 adjacent teeth intermediate extended-gap (excluding wisdom teeth) in the upper or lower jaw.
  • Patients with at least 4 conservable teeth by dental arch, without major occlusal trouble.
  • Patients with healthy periodontium, allowing metalic standard removable partial denture delivery : bleeding on periodontal probing for a duration less than 30 seconds, Osteolysis of the alveolar ridge less or equal to 50%, attachment loss less or equal to 5mm
  • Patients with a sufficient bone volume for implant placement, without prior bone supply.

Exclusion Criteria:

  • Patients with general counter-indications for implant placement.
  • Patients suffering from a titanium allergy.
  • Patients with an insufficient oral and dental hygiene - Patients smoking ten or more cigarettes per day.
  • Patients with teeth extended-gap, which could be corrected by a fixed tooth-supported denture.
  • Patient with an insufficient available bite level to deliver an attachment system (< 7mm).
  • Patients with a severe generalized chronic periodontitis , an aggressive periodontitis or a periodontitis unresponsive to treatment.
  • Women who have reported to be pregnant.
  • Patients deprived of liberty

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762201


Contacts
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Contact: Amandine LETERME, MD 427854032 ext +33 a_leterme@yahoo.fr
Contact: Karine POYAU, PhD 472115381 ext +33 karine.poyau@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon Recruiting
Lyon, France
Contact: Gilbert VIGUIE, MD    427854032 ext +33    gilbert.viguie@free.fr   
Sponsors and Collaborators
Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02762201     History of Changes
Other Study ID Numbers: 2012-726
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Tooth Loss
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Tooth Diseases