Implantology and Sjögren's Syndrome
- Conditions
- Sjogren's Syndrome
- Interventions
- Device: Biohorizons Laser-lok bonelevel dental implants
- Registration Number
- NCT02661243
- Lead Sponsor
- Derk Jan Jager
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dentate Sjogren's syndrome arm Biohorizons Laser-lok bonelevel dental implants 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 Dentate healthy controls arm Biohorizons Laser-lok bonelevel dental implants 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 Edentulous healthy controls arm Biohorizons Laser-lok bonelevel dental implants 30 healthy human edentulous adults with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants Edentulous Sjogren's syndrome arm Biohorizons Laser-lok bonelevel dental implants 30 human edentulous adults affected by SS with the need of stabilization of the dentures. Intervention: insertion of Biohorizons Laser-lok bonelevel dental implants
- Primary Outcome Measures
Name Time Method Change in marginal peri-implant bone loss of dental implants 1.5 years 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.
- Secondary Outcome Measures
Name Time Method Width of keratinized epithelium 1.5 years 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.
Patient satisfaction and impact of oral health on the quality of life 1.5 years - 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
Denture function and satisfaction 1.5 years * 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 questionnairesImplant survival 1.5 years 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.
Overdenture/crown survival 1.5 years 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.
Modified Plaque-index and Modified Bleeding-Index 1.5 years 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).
Probing depth 1.5 years 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.
Disease symptoms (SS groups only) 1.5 years 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
Trial Locations
- Locations (5)
VU Medical Center department of Maxillofacial surgery
🇳🇱Amsterdam, Netherlands
Vogellanden Center for Special Care Dentistry/Isala
🇳🇱Zwolle, Netherlands
University Medical Center Groningen
🇳🇱Groningen, Netherlands
Tandartspraktijk Bocht Oosterdiep
🇳🇱Veendam, Netherlands
University Medical Center Utrecht
🇳🇱Utrecht, Netherlands