Implantology and Sjögren's Syndrome

NCT02661243 | Completed DMC

• 1 other identifier: NL47808.029.14
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 5

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.

Conditions

Sjogren's Syndrome

Keywords

Sjogren's Syndrome; Dental Implants

Outcome Measures

Primary Outcomes (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.

  1.5 years

Secondary Outcomes (8)

• Implant survival

  1.5 years

• Overdenture/crown survival

  1.5 years

• Modified Plaque-index and Modified Bleeding-Index

  1.5 years

• Probing depth

  1.5 years

• Width of keratinized epithelium

  1.5 years

Study Arms (4)

Dentate Sjogren's syndrome arm

OTHER

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

Dentate healthy controls arm

OTHER

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

Edentulous Sjogren's syndrome arm

OTHER

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

Edentulous healthy controls arm

OTHER

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

Interventions

Biohorizons Laser-lok bonelevel dental implants DEVICE

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

Dentate Sjogren's syndrome arm; Dentate healthy controls arm; Edentulous Sjogren's syndrome arm; Edentulous healthy controls arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Derk Jan Jager: lead
• UMC Utrecht: collaborator
• University Medical Center Groningen: collaborator
• Tandartspraktijk Bocht Oosterdiep: collaborator
• Isala: collaborator
• BioHorizons, Inc.: collaborator
• Fonds NutsOhra: collaborator

Study Sites (5)

VU Medical Center department of Maxillofacial surgery

Amsterdam, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Tandartspraktijk Bocht Oosterdiep

Veendam, 9641 JH, Netherlands

Location

Vogellanden Center for Special Care Dentistry/Isala

Zwolle, 8001 BB, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 19040585 BACKGROUND

• 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.

  PMID: 19212238 BACKGROUND

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

  PMID: 16039337 BACKGROUND

• 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.

  PMID: 12006334 BACKGROUND

• 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.

  PMID: 15212345 BACKGROUND

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Derk Jan Jager, DMD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: January 18, 2016
• First Posted: January 22, 2016
• Study Start: May 1, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)