Implantology and Sjögren*s syndrome: a multicenter prospective cohort study

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Inclusion criteria (dentate group, Sjögren)
- The patient is at least 18 years and younger than 80;
- A diagnosed (by the AECG guidelines; see attachment) 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 mixed with artificial bone (tricalcium phosphate 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 80;
- A diagnosed (by the EULAR guidelines) 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.
- 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 and/or sinus elevation procedure will be performed with autologue bone mixed with artificial bone (tricalcium phosphate 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.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Changes in marginal peri-implant bone loss of dental implants between the<br /><br>healthy and SS groups 1.5 years after finalization. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Difference in clinical performance of dental implants between healthy and SS<br /><br>patients. Furthermore, a possible association between the outcome measures and<br /><br>Sjögrens syndrome disease symptoms is studied.<br /><br><br /><br>Clinical performance:<br /><br>- Implant survival.<br /><br>- Overdenture/crown survival.<br /><br>- Modified plaque-index and modified bleeding-index.<br /><br>- Probing depth.<br /><br>- Width of keratinized epithelium.<br /><br>- Patient satisfaction and impact of oral health on the quality of life.<br /><br><br /><br>Sjogrens syndrome disease symptoms (EULAR Sjögren*s Syndrome Patient Reported<br /><br>Index [ESSPRI]; SS groups only).</p><br>