Implantology and Sjögren's Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sjogren's Syndrome

Intervention / Treatment
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* Device: Biohorizons Laser-lok bonelevel dental implants


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Dentate Sjogren's syndrome arm<br>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<br>* Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture<br>|
| Other: Dentate healthy controls arm<br>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<br>* Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture<br>|
| Other: Edentulous Sjogren's syndrome arm<br>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<br>* Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture<br>|
| Other: Edentulous healthy controls arm<br>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<br>* Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1.5 years | 
| 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. | 1.5 years | 
| 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). | 1.5 years | 
| 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. | 1.5 years | 
| 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. | 1.5 years | 
| 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 | 1.5 years | 
| 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 | 1.5 years | 
| 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 | 1.5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Implants, Sjogren's Syndrome