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Sjogren's SyndromeNCT02661243

Implantology and Sjögren's Syndrome

A study testing Biohorizons Laser-lok bonelevel dental implants in people with Sjogren's Syndrome, run by Derk Jan Jager at 5 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Sjogren's Syndrome
What is being tested?
Biohorizons Laser-lok bonelevel dental implants
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesNetherlands
Study dates
May 2015to Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 17Show fewer
  • Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic restoration;
  • The patient is capable of understanding and giving informed consent.
  • 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.
  • The inclusion criteria for the healthy control groups are similar as for the Sjögren groups without the Sjögren criterion.

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

Netherlands5 sites

  • VU Medical Center department of Maxillofacial surgery

    Amsterdam

  • University Medical Center Groningen

    Groningen, 9700 RB

  • University Medical Center Utrecht

    Utrecht, 3508 GA

  • Tandartspraktijk Bocht Oosterdiep

    Veendam, 9641 JH

  • Vogellanden Center for Special Care Dentistry/Isala

    Zwolle, 8001 BB

Other trials in Netherlands

About this study

Official title: Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study

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.

Read the 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.

Being tested
Biohorizons Laser-lok bonelevel dental implants
Keywords
Sjogren's Syndrome, Dental Implants
Medical subject headings
Sjogren's Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biohorizons Laser-lok bonelevel dental implantsDevice

    Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture

Study groups in NCT02661243
Study groupRoleWhat they receive
Dentate Sjogren's syndrome armOther30 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
Receives: Device: Biohorizons Laser-lok bonelevel dental implants
Dentate healthy controls armOther30 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
Receives: Device: Biohorizons Laser-lok bonelevel dental implants
Edentulous Sjogren's syndrome armOther30 human edentulous adults affected by SS with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
Receives: Device: Biohorizons Laser-lok bonelevel dental implants
Edentulous healthy controls armOther30 healthy human edentulous adults with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
Receives: Device: Biohorizons Laser-lok bonelevel dental implants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in marginal peri-implant bone loss of dental implants

    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.

    Measured: 1.5 years

Secondary outcomes (8)

  1. Implant survival

    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.

    Measured: 1.5 years

  2. Overdenture/crown survival

    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.

    Measured: 1.5 years

  3. Modified Plaque-index and Modified Bleeding-Index

    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).

    Measured: 1.5 years

  4. Probing depth

    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.

    Measured: 1.5 years

  5. Width of keratinized epithelium

    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.

    Measured: 1.5 years

  6. Patient satisfaction and impact of oral health on the quality of life

    • 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

    Measured: 1.5 years

  7. Denture function and satisfaction

    • 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

    Measured: 1.5 years

  8. Disease symptoms (SS groups only)

    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

    Measured: 1.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionFeb 2019
  4. Study completionFeb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02661243
Sponsor's protocol ID
NL47808.029.14
Status last verified
Apr 2019
First submitted
18 Jan 2016
Last updated
30 Apr 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • den Hartog L, Slater JJ, Vissink A, Meijer HJ, Raghoebar GM. Treatment outcome of immediate, early and conventional single-tooth implants in the aesthetic zone: a systematic review to survival, bone level, soft-tissue, aesthetics and patient satisfaction. J Clin Periodontol. 2008 Dec;35(12):1073-86. doi: 10.1111/j.1600-051X.2008.01330.x.

    PubMed 19040585

  • Pecora GE, Ceccarelli R, Bonelli M, Alexander H, Ricci JL. Clinical evaluation of laser microtexturing for soft tissue and bone attachment to dental implants. Implant Dent. 2009 Feb;18(1):57-66. doi: 10.1097/ID.0b013e31818c5a6d.

    PubMed 19212238

  • Fox RI. Sjogren's syndrome. Lancet. 2005 Jul 23-29;366(9482):321-31. doi: 10.1016/S0140-6736(05)66990-5.

    PubMed 16039337

  • Vitali C, Bombardieri S, Jonsson R, Moutsopoulos HM, Alexander EL, Carsons SE, Daniels TE, Fox PC, Fox RI, Kassan SS, Pillemer SR, Talal N, Weisman MH; European Study Group on Classification Criteria for Sjogren's Syndrome. Classification criteria for Sjogren's syndrome: a revised version of the European criteria proposed by the American-European Consensus Group. Ann Rheum Dis. 2002 Jun;61(6):554-8. doi: 10.1136/ard.61.6.554.

    PubMed 12006334

  • Meijndert L, Meijer HJ, Raghoebar GM, Vissink A. A technique for standardized evaluation of soft and hard peri-implant tissues in partially edentulous patients. J Periodontol. 2004 May;75(5):646-51. doi: 10.1902/jop.2004.75.5.646.

    PubMed 15212345

Questions about this trial

What is this clinical trial studying?

A study testing Biohorizons Laser-lok bonelevel dental implants in people with Sjogren's Syndrome, run by Derk Jan Jager at 5 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in marginal peri-implant bone loss of dental implants (time frame: 1.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02661243, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2019.

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