Implantology and Sjögren's Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Sjogren's Syndrome
• Intervention / Treatment: Device: Biohorizons Laser-lok bonelevel dental implants

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • VU Medical Center department of Maxillofacial surgery
  • Groningen, Netherlands, 9700 RB
    • University Medical Center Groningen
  • Utrecht, Netherlands, 3508 GA
    • University Medical Center Utrecht
  • Veendam, Netherlands, 9641 JH
    • Tandartspraktijk Bocht Oosterdiep
  • Zwolle, Netherlands, 8001 BB
    • Vogellanden Center for Special Care Dentistry/Isala

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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
Other: 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
Other: 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
Other: 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Derk Jan Jager
• Collaborators: University Medical Center Groningen; UMC Utrecht; Fonds NutsOhra; Isala; Tandartspraktijk Bocht Oosterdiep; BioHorizons, Inc.
• Investigators: Principal Investigator: Derk Jan Jager, DMD, PhD, Amsterdam Umc, Location Vumc

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 1, 2019

Study Registration Dates

• First Submitted: January 18, 2016
• First Submitted That Met QC Criteria: January 18, 2016
• First Posted (Estimate): January 22, 2016

Study Record Updates

• Last Update Posted (Actual): April 30, 2019
• Last Update Submitted That Met QC Criteria: April 26, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Sjogren's Syndrome; Dental Implants
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: NL47808.029.14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No