Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome
Condition: Dental Implant; Primary Sjögren Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Study type: Interventional

Summary: 
      Primary Sjögren's Syndrome (PSS) is a chronic autoimmune inflammatory disease primarily
      involving the salivary and lacrimal glands. Few data exist regarding survival and success
      rate of dental implants in patients with PSS. Although a previous study suggest lower success
      rate for dental implants we hypothesize that dental implants have similar survival and
      success rate in PSS as healthy controls.

      The purpose of the present study was to evaluate the long-term survival and success rate of
      dental implants in patients with PSS compared to the healthy controls.
    

Detailed description: 
      Sjögren's syndrome (SS) affects about 5% of population worldwide. Patients with Primary
      Sjögren's Syndrome (PSS) have dry mouth, oral mucosal problems, increased dental decay and
      problems wearing dentures. A retrospective case series indicated that implant survival rate
      may be reduced among SS patients. Furthermore, there is lack of scientific evidence to
      support success or failure of dental implants in SS-patients.

      The null hypothesis is that the outcome of implant treatment after 5 years is similar in
      patients with primary Sjögren's Syndrome (pSS) compared to matched controls.

      The participants with PSS fulfilled the Copenhagen Criteria and/or the US-EU criteria for
      PSS, miss at least one tooth and have sufficient bone volume for a single implant insertion
      without bone augmentation.

      Recruitment of PSS patients was done via own existing databases on PSS patients as well as
      repeated national announcements in the Danish Dental Journal.

      We included 24 consecutive participants with PSS. For each participant with PSS (test group),
      an age, gender, and tooth-type matched healthy participant (control group) was enrolled
      (n=24).

      The surgical part of the implant treatment was carried out by two experienced maxillofacial
      surgeons. Straumann implants (Straumann Bone level Roxolid®) with a hydrophilic sandblasted,
      acid etched implant surface (SLActive) was used for all participants. If more than one
      implant was placed, the study implant was determined according to a randomization scheme.

      The inserted implants were allowed to heal for 3 months before the prosthetic part, which was
      carried out by two experienced prostodontists. The same prosthetic material and method was
      applied for all participants.

      The participants were recalled for baseline (2 months after prosthetic loading) and 1, 3 and
      5 years examination, where the biological (marginal bone level, inflammation etc.), technical
      (fractures, loosening's etc.), esthetic (Copenhagen Index score) and patient-reported (Oral
      Health Impact Profile questionnaire/OHIP-49) assessments were performed.
    

Intervention name(s): Dental implants
Intervention type(s): Procedure
Intervention description(s): Treatment of the toothless regions with dental implants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective study
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dental Implants; Primary Sjögren syndrom; Biological outcome; Technical outcome; Aesthetic outcome; Patient-reported outcome