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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Treatment of the toothless regions with dental implants
Number of patients with Sjögren syndrom
number of participants in the test group
Time frame: Five years
Number of patients without Sjögren syndrom
number of participants in the control group
Time frame: Five years
Number of implants in each group
number of implants in patients with or without Sjögren syndrom
Time frame: Five years
Marginal bone loss
Marginal bone level change over the time in millimeter: radiological examinations and measurements of the marginal bone at implants mesially and distally (millimeter) and the change of the marginal bone level between different observation
Time frame: Five years
Frequency of implant sites with biological complications
Frequency of implant sites with sign of inflammatory reactions with or without marginal bone loss (periimplantitis or peri-implant mucositis). The number of implant sites with bleeding on probing, suppuration or fistula will be registered and described.
Time frame: 5 year
Sialometry
measurement of stimulated or unstimulated saliva flow, ml/min for all participants and statistical comparison between the participants in both groups.
Time frame: 5 year
Technical outcome
The frequency of prosthetic complications such as fracture or loosening of implant-supported crowns at all implant sites in all participants and comparison between to groups
Time frame: 5 years
Aesthetic outcome by Copenhagen Index Scores
Aesthetic parameters: Symmetry/harmony, Crown morphology, Crown color match, mucosal discoloration, Papilla Index score mesially and distally Score 1, 2, 3 and 4 (socre 1 for the most optimal and socre 4 for unacceptable aesthetic outcome)
Time frame: 5 year
Patient-reported outcome
Oral Health Impact on the Quality of Life (OHIP-49 questionnaire) Response scale from 0 (never experienced problem) to 4 (problem experienced very often).
Time frame: 5 years
Decayed, Missing, Filled Tooth index (DMFT)
Caries experience by calculation of total number of tooth with Decayed, Missing or Filled tooth. Less scores indicating better dental condition. Both groups will be compared and the relation to sialometry will be analyzed.
Time frame: 5 years
Modified Plaque Index
The Oral hygiene of the patients will be measured by recording the amount of the plaque on the implants and all natural teeth using the following scale: (score 1 to 4) Score 1: no visible plaque; Score 2: small amount of hardly visible plaque; Score 3: moderate amount of plaque; Score 4: abundant amount of plaque The difference in plaque index and the relation to the biological complication will be statistically analyzed in both group of participants.
Time frame: 5 years
Modified Mucosal Index scores
The sign of inflammatory reactions around the implants will be measured by using the following scores: (score 1 to 4) Score 1: normal appearance of gingiva/mucosa; Score 2: slight redness or hyperplasia; Score 3: moderate inflammation with marked redness and hyperplasia and easily bleeding by probing; Score 4: Severe inflammation with severe redness and hyperplasia and spontaneous bleeding The difference in mucosal index and the relation to the plaque index will be statistically analyzed in both group of participants.
Time frame: 5 years
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