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Implantology and Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT02661243
Recruitment Status : Recruiting
First Posted : January 22, 2016
Last Update Posted : May 11, 2017
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

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.

Condition or disease Intervention/treatment Phase
Sjogren's Syndrome Device: Biohorizons Laser-lok bonelevel dental implants Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study
Study Start Date : May 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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

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
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

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
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

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
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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

  7. 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


  8. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02661243


Contacts
Contact: Derk Jan Jager, DMD, PhD +2044441033 d.jager@vumc.nl
Contact: Floor Maarse, DMD f.maarse@vumc.nl

Locations
Netherlands
VU Medical Center department of Maxillofacial surgery Recruiting
Amsterdam, Netherlands
Contact: Derk-Jan Jager, DMD, PhD       d.jager@vumc.nl   
Contact: Floor Maarse, DMD       f.maarse@vumc.nl   
Principal Investigator: Derk Jan Jager, MD, PhD         
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Anke Korfage, DMD, PhD       a.korfage@umcg.nl   
University Medical Center Utrecht Recruiting
Utrecht, Netherlands, 3508 GA
Contact: Willem Fennis, DMD, PhD    +31 88 75 577 62    W.M.M.Fennis-2@umcutrecht.nl   
Tandartspraktijk Bocht Oosterdiep Not yet recruiting
Veendam, Netherlands, 9641 JH
Contact: Eric Santing, DMD, PhD       eric@bochtoosterdiep.nl   
Vogellanden Center for Special Care Dentistry/Isala Not yet recruiting
Zwolle, Netherlands, 8001 BB
Contact: Paul Versteegh, DMD       paverst@me.nl   
Contact: Willemijn van der Sleen - Schulten, DMD       w.van.der.sleen@vogellanden.nl   
Sponsors and Collaborators
Derk Jan Jager
UMC Utrecht
University Medical Center Groningen
Tandartspraktijk Bocht Oosterdiep
Isala
BioHorizons, Inc.
Fonds NutsOhra
Investigators
Principal Investigator: Derk Jan Jager, DMD, PhD VU University Medical Center

Publications:
Responsible Party: Derk Jan Jager, PhD, VU University Medical Center
ClinicalTrials.gov Identifier: NCT02661243     History of Changes
Other Study ID Numbers: NL47808.029.14
First Posted: January 22, 2016    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Derk Jan Jager, VU University Medical Center:
Sjogren's Syndrome
Dental Implants

Additional relevant MeSH terms:
Xerostomia
Mouth Diseases
Dry Eye Syndromes
Syndrome
Sjogren's Syndrome
Disease
Pathologic Processes
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Stomatognathic Diseases
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases