Implantology and Sjögren's Syndrome

NCT ID: NCT02661243

Last Updated: 2019-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2019-02-28

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.

Conditions

Sjogren's Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Biohorizons Laser-lok bonelevel dental implants

Intervention Type: DEVICE

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

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

Group Type: OTHER

Biohorizons Laser-lok bonelevel dental implants

Intervention Type: DEVICE

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

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

Group Type: OTHER

Biohorizons Laser-lok bonelevel dental implants

Intervention Type: DEVICE

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

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

Group Type: OTHER

Biohorizons Laser-lok bonelevel dental implants

Intervention Type: DEVICE

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

Interventions

Biohorizons Laser-lok bonelevel dental implants

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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
• 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.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

UMC Utrecht

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: collaborator

Tandartspraktijk Bocht Oosterdiep

UNKNOWN

Sponsor Role: collaborator

Isala

OTHER

Sponsor Role: collaborator

BioHorizons, Inc.

INDUSTRY

Sponsor Role: collaborator

Fonds NutsOhra

OTHER

Sponsor Role: collaborator

Derk Jan Jager

OTHER

Sponsor Role: lead

Responsible Party

Derk Jan Jager

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Derk Jan Jager, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amsterdam UMC, location VUmc

Locations

VU Medical Center department of Maxillofacial surgery

Amsterdam, , Netherlands

University Medical Center Groningen

Groningen, , Netherlands

University Medical Center Utrecht

Utrecht, , Netherlands

Tandartspraktijk Bocht Oosterdiep

Veendam, , Netherlands

Vogellanden Center for Special Care Dentistry/Isala

Zwolle, , Netherlands

Countries

Netherlands

References

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.

Reference Type: BACKGROUND

PMID: 19040585 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19212238 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 16039337 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12006334 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15212345 (View on PubMed)

Other Identifiers

NL47808.029.14

Identifier Type: -

Identifier Source: org_study_id