Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome (NCT04960605) | Clinical Trial Compass
CompletedNot Applicable
Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome
48 participantsStarted 2015-01-01
Plain-language 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.
Who can participate
Age range20 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. The presence of any 4 of the following 6 items, as long as either item IV (Histopathology) or VI (Serology) is positive
✓. The presence of any 3 of the 4 objective criteria items (that is, items III, IV, V, VI)
✓. Have you had daily, persistent, troublesome dry eyes for more than 3 months?
✓. Do you have a recurrent sensation of sand or gravel in the eyes?
✓. Do you use tear substitutes more than 3 times a day?
✓. Have you had a daily feeling of dry mouth for more than 3 months?
✓. Have you had recurrently or persistently swollen salivary glands as an adult?
✓. Do you frequently drink liquids to aid in swallowing dry food?
Exclusion criteria
✕. secundary Sjögren Syndrom (sSS)
✕. severe systemic disease including severe bleeding disorder and/or conditions which put the patient at risk and/or prohibit compliance as stated by Hwang and Wang, 2006; and Hwang and Wang, 2007):
✕. previous or present bisphosphonate, Denosumab or anti-angiogenetic chemotherapeutic drugs
✕. poor bone quality according to Lekholm U \& Zarb GA (1985) or diagnosed osteoporosis
What they're measuring
1
Number of patients with Sjögren syndrom
Timeframe: Five years
2
Number of patients without Sjögren syndrom
Timeframe: Five years
3
Number of implants in each group
Timeframe: Five years
4
Marginal bone loss
Timeframe: Five years
5
Frequency of implant sites with biological complications