Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2025-12-25 @ 3:25 AM
NCT ID:
NCT04960605
Eligibility Criteria:
Inclusion Criteria:
* \- Age 20-70 years
* Indication of tooth replacement with implant-supported fixed dentures
* The test group should be without any potentially associated disease
* pSS must be diagnosed according to the American-European Consensus Group criteria (Vitali et al., 2002):
1. The presence of any 4 of the following 6 items, as long as either item IV (Histopathology) or VI (Serology) is positive
2. The presence of any 3 of the 4 objective criteria items (that is, items III, IV, V, VI)
The items:
I. Ocular symptoms: a positive response to at least one of the following questions:
1. Have you had daily, persistent, troublesome dry eyes for more than 3 months?
2. Do you have a recurrent sensation of sand or gravel in the eyes?
3. Do you use tear substitutes more than 3 times a day?
II. Oral symptoms: a positive response to at least one of the following questions:
1. Have you had a daily feeling of dry mouth for more than 3 months?
2. Have you had recurrently or persistently swollen salivary glands as an adult?
3. Do you frequently drink liquids to aid in swallowing dry food?
III. Ocular signs --that is, objective evidence of ocular involvement defined as a positive result for at least one of the following two tests:
1. Schirmer's I test, performed without anaesthesia (\<5 mm in 5 minutes)
2. Rose bengal score or other ocular dye score (\>4 according to van Bijsterveld's scoring system) IV. Histopathology: In minor salivary glands (obtained through normal-appearing mucosa) focal lymphocytic sialoadenitis, evaluated by an expert histopathologist, with a focus score \>1, defined as a number of lymphocytic foci (which are adjacent to normal-appearing mucous acini and contain more than 50 lymphocytes) per 4 mm2 of glandular tissue
V. Salivary gland involvement: objective evidence of salivary gland involvement defined by a positive result for at least one of the following diagnostic tests:
1. Unstimulated whole salivary flow (\<1.5 ml in 15 minutes)
2. Parotid sialography showing the presence of diffuse sialectasias (punctate, cavitary or destructive pattern), without evidence of obstruction in the major ducts
3. Salivary scintigraphy showing delayed uptake, reduced concentration and/or delayed excretion of tracer
VI. Autoantibodies: presence in the serum of the following autoantibodies:
1\. Antibodies to Ro(SSA) or La(SSB) antigens, or both
* The control group should match the test group according to the age, sex and treatment region and fulfill the following:
* Normal salivary flow: unstimulated \> 1.5 ml in 15 min, stimulated \> 3.5 ml in 5 min
* No ocular or oral symptoms
* Submission of written informed consent form
Exclusion Criteria:
* Persons with:
1. secundary Sjögren Syndrom (sSS)
2. 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):
3. previous or present bisphosphonate, Denosumab or anti-angiogenetic chemotherapeutic drugs
4. poor bone quality according to Lekholm U \& Zarb GA (1985) or diagnosed osteoporosis
5. Heavy smokers, eqv. to 20+ cigarettes/day
6. Noncompliance
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT04960605
Study Brief:
Protocol Section:
NCT04960605