Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome. A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 主要终点
- Marginal bone loss
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The statistical analyses will be masked.
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- 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):
- •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)
- •I. Ocular symptoms: a positive response to at least one of the following questions:
- •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?
- •II. Oral symptoms: a positive response to at least one of the following questions:
- •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?
- •III. Ocular signs --that is, objective evidence of ocular involvement defined as a positive result for at least one of the following two tests:
- •Schirmer's I test, performed without anaesthesia (<5 mm in 5 minutes)
- •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:
- •Unstimulated whole salivary flow (<1.5 ml in 15 minutes)
- •Parotid sialography showing the presence of diffuse sialectasias (punctate, cavitary or destructive pattern), without evidence of obstruction in the major ducts
- •Salivary scintigraphy showing delayed uptake, reduced concentration and/or delayed excretion of tracer
- •VI. Autoantibodies: presence in the serum of the following autoantibodies:
- •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
排除标准
- •Persons with:
- •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
- •Heavy smokers, eqv. to 20+ cigarettes/day
- •Noncompliance
结局指标
主要结局
Marginal bone loss
时间窗: Five years
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
Technical outcome
时间窗: 5 years
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
Aesthetic outcome by Copenhagen Index Scores
时间窗: 5 year
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)
Number of patients with Sjögren syndrom
时间窗: Five years
number of participants in the test group
Frequency of implant sites with biological complications
时间窗: 5 year
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.
Sialometry
时间窗: 5 year
measurement of stimulated or unstimulated saliva flow, ml/min for all participants and statistical comparison between the participants in both groups.
Number of patients without Sjögren syndrom
时间窗: Five years
number of participants in the control group
Number of implants in each group
时间窗: Five years
number of implants in patients with or without Sjögren syndrom
Patient-reported outcome
时间窗: 5 years
Oral Health Impact on the Quality of Life (OHIP-49 questionnaire) Response scale from 0 (never experienced problem) to 4 (problem experienced very often).
次要结局
- Modified Mucosal Index scores(5 years)
- Decayed, Missing, Filled Tooth index (DMFT)(5 years)
- Modified Plaque Index(5 years)
研究者
Mandana Hosseini
Guest researcher
University of Copenhagen