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Implantology and Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT02661243
Recruitment Status : Completed
First Posted : January 22, 2016
Last Update Posted : April 30, 2019
Sponsor:
Collaborators:
UMC Utrecht
University Medical Center Groningen
Tandartspraktijk Bocht Oosterdiep
Isala
BioHorizons, Inc.
Fonds NutsOhra
Information provided by (Responsible Party):
Derk Jan Jager, VU University Medical Center

Tracking Information
First Submitted Date  ICMJE January 18, 2016
First Posted Date  ICMJE January 22, 2016
Last Update Posted Date April 30, 2019
Study Start Date  ICMJE May 2015
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
Change in marginal peri-implant bone loss of dental implants [ Time Frame: 1.5 years ]
changes in marginal peri-implant bone loss of dental implants between the healthy and SS groups and differences in clinical performance 1.5 years after finalization.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02661243 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2016)
  • Implant survival [ Time Frame: 1.5 years ]
    The survival rate of the fixture is assessed 1 month, 6 months, 1 year and 1.5 years after placement of the definitive restoration. Implant survival is defined as presence of the implant at time of the follow-up examinations.
  • Overdenture/crown survival [ Time Frame: 1.5 years ]
    The survival (i.e. fully intact) rate of the denture or crown is assessed 1 month, 6 months, 1 year and 1.5 years after placement of the definitive restoration.
  • Modified Plaque-index and Modified Bleeding-Index [ Time Frame: 1.5 years ]
    These parameters are evaluated pre-operative, 1 month, 6 months, 1 year and 1.5 years after placement of the definitive restoration. The adjacent teeth are counted as well in the assessments (dentate groups only).
  • Probing depth [ Time Frame: 1.5 years ]
    Probing of the implant and the adjacent teeth (dentate groups only) is performed at three sites, buccodistal, buccomedial, buccomesial. The probing depth is measured 1 month, 6 months, one year and 1.5 years after placement of the definitive restoration.
  • Width of keratinized epithelium [ Time Frame: 1.5 years ]
    The width in millimetres of keratinized epithelium is measured pre-operative, 1 month, 6 months, 1 year and 1.5 years after the definitive restoration has been placed. For this a periodontal probe is used.
  • Patient satisfaction and impact of oral health on the quality of life [ Time Frame: 1.5 years ]
    - All patients: OHIP-NL14. Oral Health Impact Profile. An instrument for measuring the impact of oral health on the quality of life. A validated Dutch-language version of the OHIP-14, a questionnaire by means of which the impact of oral health on the quality of life of patients can be determined is completed by every participant at every examination
  • Denture function and satisfaction [ Time Frame: 1.5 years ]
    • Edentulous groups: the following validated questionnaires are used for the edentulous groups only (see attachment; Vervoorn et al., 1988):
    • A. General experience with the denture, including a grade from 1 tot 10
    • B. Complaints form with regard to aesthetics and function of the denture
    • C. Chewing list (which food can be chewed well and which food is difficult to chew).
    The participant at every time point completes these questionnaires
  • Disease symptoms (SS groups only) [ Time Frame: 1.5 years ]
    patients in the SS groups are asked to complete the EULAR Sjögren's Syndrome Patient Reported Index and the EULAR Sjögren's Syndrome Disease Activity Index (ESSPRI & ESSDAI; see attachment) questionnaire with regard to disease symptoms
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implantology and Sjögren's Syndrome
Official Title  ICMJE Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study
Brief Summary Until now it has not been investigated whether placement of implants in SS patients is less successful than compared to non-SS patients. The risk factors and the efficacy of dental implants in dry mouth patients are not known because of the lack of scientific evidence. The aim of this study is to investigate changes in marginal peri-implant bone loss and the clinical performance of dental implants in SS patients compared to implants in healthy patients.
Detailed Description

Rationale: Until now it has not been investigated whether placement of implants in SS patients is less successful than compared to non-SS patients. The risk factors and the efficacy of dental implants in dry mouth patients are not known because of the lack of scientific evidence.

Objective: to investigate changes in marginal peri-implant bone loss and the clinical performance of dental implants in SS patients compared to implants in healthy patients.

Study design: A prospective multicenter clinical trial.

Study population: N = 120

Intervention: All patients receive Biohorizons Laser-lok bonelevel implants to replace the missing (pre)molars or to support a full denture in the upper and lower jaw .

This study is comprised of four study groups:

  • 30 human adults affected by SS with the need of replacement of missing premolars or molars in the upper or lower jaw.
  • 30 healthy human adults with the need of replacement of missing premolars or molars in the upper or lower jaw.
  • 30 human edentulous adults affected by SS with the need of stabilization of the dentures.
  • 30 healthy human edentulous adults with the need of stabilization of the dentures.

Main study parameters/endpoints: changes in marginal peri-implant bone loss of dental implants between the healthy and SS groups and differences in clinical performance 1.5 years after finalization.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sjogren's Syndrome
Intervention  ICMJE Device: Biohorizons Laser-lok bonelevel dental implants
Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture
Study Arms  ICMJE
  • Dentate Sjogren's syndrome arm
    30 human adults affected by SS with the need of replacement of missing premolars or molars in the upper or lower jaw. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
    Intervention: Device: Biohorizons Laser-lok bonelevel dental implants
  • Dentate healthy controls arm
    30 healthy human adults with the need of replacement of missing premolars or molars in the upper or lower jaw. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
    Intervention: Device: Biohorizons Laser-lok bonelevel dental implants
  • Edentulous Sjogren's syndrome arm
    30 human edentulous adults affected by SS with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
    Intervention: Device: Biohorizons Laser-lok bonelevel dental implants
  • Edentulous healthy controls arm
    30 healthy human edentulous adults with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
    Intervention: Device: Biohorizons Laser-lok bonelevel dental implants
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2016)
120
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2019
Actual Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria (dentate group, Sjögren):

  • The patient is at least 18 years and younger than 70;
  • A diagnosed (by the AECG guidelines; see attachment; Vitali et al., 2002) primary or secondary Syndrome of Sjögren;
  • The missing or lost tooth/teeth are premolars and/or molars in the upper or lower jaw.
  • Sufficient healthy and vital bone to insert a dental implant with a minimum length of 8 mm and at least 3.8 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone. If necessary the autologue bone can be mixed with artificial bone (artificial bone graft substitutes in combination with a membrane).
  • The implant site must be free from infection;
  • Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1) (Mombelli et al., 1987; Loe and Silness, 1963)
  • Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
  • The patient is capable of understanding and giving informed consent.

Inclusion criteria (edentulous group, Sjögren):

  • The patient is at least 18 years and younger than 70;
  • A diagnosed (by the AECG guidelines; Vitali et al., 2002) primary or secondary Syndrome of Sjögren
  • The patient is edentulous. Before final inclusion in the study the patient has to be edentulous for 1 year.
  • Problems with conventional denture retention, stability and/or adaptation, which could be solved by an implant, supported denture (lower or/and upper jaw).
  • Sufficient healthy and vital bone to insert dental implants with a minimum length of 8 mm and at least 3.8 mm in diameter. In case of insufficient bone volume, a bone augmentation procedure will be performed with autologue bone. If necessary the autologue bone can be mixed with artificial bone (artificial bone graft substitutes in combination with a membrane).
  • The implant site must be free from infection;
  • Capable of performing adequate oral hygiene;
  • The patient is capable of understanding and giving informed consent.

Inclusion criteria control groups:

- The inclusion criteria for the healthy control groups are similar as for the Sjögren groups without the Sjögren criterion.

Exclusion criteria:

Criteria used for excluding patients from this study are as follows:

  • Medical and general contraindications for the surgical procedures;
  • Presence of an active and uncontrolled periodontal disease as expressed by probing pockets depths > 4mm with bleeding upon probing;
  • Smoking (patients who stop smoking six weeks before the operation can be included);
  • A history of radiotherapy to the head and neck region;
  • Use of intravenous bisphosphonates or the use of oral bisphosphonates for more than 5 years.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02661243
Other Study ID Numbers  ICMJE NL47808.029.14
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Derk Jan Jager, VU University Medical Center
Study Sponsor  ICMJE Derk Jan Jager
Collaborators  ICMJE
  • UMC Utrecht
  • University Medical Center Groningen
  • Tandartspraktijk Bocht Oosterdiep
  • Isala
  • BioHorizons, Inc.
  • Fonds NutsOhra
Investigators  ICMJE
Principal Investigator: Derk Jan Jager, DMD, PhD VU University Medical Center
PRS Account VU University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP