Clinical trial NCT02661243: Implantology and Sjögren's Syndrome
Official title: Implantology and Sjögren's Syndrome: a Multicenter Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sjogren's Syndrome
Keywords: Sjogren's Syndrome
Dental Implants
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: University Medical Center Groningen
name: Tandartspraktijk Bocht Oosterdiep
name: Isala
name: BioHorizons, Inc.
name: Fonds NutsOhra
First posted: 2016-01-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change in marginal peri-implant bone loss of dental implants
timeFrame: 1.5 years
Secondary outcomes:
measure: Implant survival
timeFrame: 1.5 years
measure: Overdenture/crown survival
timeFrame: 1.5 years
measure: Modified Plaque-index and Modified Bleeding-Index
timeFrame: 1.5 years
measure: Probing depth
timeFrame: 1.5 years
measure: Width of keratinized epithelium
timeFrame: 1.5 years
measure: Patient satisfaction and impact of oral health on the quality of life
timeFrame: 1.5 years
measure: Denture function and satisfaction
timeFrame: 1.5 years
measure: Disease symptoms (SS groups only)
timeFrame: 1.5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: VU Medical Center department of Maxillofacial surgery
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Veendam
country: Netherlands
facility: Tandartspraktijk Bocht Oosterdiep
city: Zwolle
country: Netherlands
facility: Vogellanden Center for Special Care Dentistry/Isala
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Derk Jan Jager, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Fox RI. Sjogren's syndrome. Lancet. 2005 Jul 23-29;366(9482):321-31. doi: 10.1016/S0140-6736(05)66990-5.
citation: 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.
citation: 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.