AzTrials
AzTrials

Dental ImplantNCT04960605

Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome

A study testing Dental implants in people with Dental Implant and Primary Sjögren Syndrome, run by University of Copenhagen.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Dental Implant, Primary Sjögren Syndrome
What is being tested?
Dental implants
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
1 Jan 2015to 27 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • - 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)
Show all 28Show fewer
  • The items:
  • 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?
  • 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?
  • 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
  • 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
  • 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

Who cannot join

  • 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

About this study

Official title: Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome. A Prospective Study

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.

Read the 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.

Being tested
Dental implants
Keywords
Dental Implants, Primary Sjögren syndrom, Biological outcome, Technical outcome, Aesthetic outcome, Patient-reported outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dental implantsProcedure or surgery

    Treatment of the toothless regions with dental implants

Study groups in NCT04960605
Study groupRoleWhat they receive
Test groupOtherPatients with Primary Sjögren Syndrom
Receives: Procedure: Dental implants
Control groupOtherPatients with Primary Sjögren Syndrom, matched to the test group
Receives: Procedure: Dental implants

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with Sjögren syndrom

    number of participants in the test group

    Measured: Five years

  2. Number of patients without Sjögren syndrom

    number of participants in the control group

    Measured: Five years

  3. Number of implants in each group

    number of implants in patients with or without Sjögren syndrom

    Measured: Five years

  4. 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

    Measured: Five years

  5. 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.

    Measured: 5 year

  6. Sialometry

    measurement of stimulated or unstimulated saliva flow, ml/min for all participants and statistical comparison between the participants in both groups.

    Measured: 5 year

  7. 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

    Measured: 5 years

  8. 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)

    Measured: 5 year

  9. 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).

    Measured: 5 years

Secondary outcomes (3)

  1. 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.

    Measured: 5 years

  2. 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.

    Measured: 5 years

  3. 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.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start1 Jan 2015
  3. Primary completion27 Oct 2023
  4. Study completion27 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Prospective study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04960605
Sponsor's protocol ID
1036_2015
Status last verified
Nov 2023
First submitted
14 Jun 2021
Last updated
1 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Isidor F, Brondum K, Hansen HJ, Jensen J, Sindet-Pedersen S. Outcome of treatment with implant-retained dental prostheses in patients with Sjogren syndrome. Int J Oral Maxillofac Implants. 1999 Sep-Oct;14(5):736-43.

    PubMed 10531746

  • Pedersen AM, Bardow A, Nauntofte B. Salivary changes and dental caries as potential oral markers of autoimmune salivary gland dysfunction in primary Sjogren's syndrome. BMC Clin Pathol. 2005 Mar 1;5(1):4. doi: 10.1186/1472-6890-5-4.

    PubMed 15740617

  • Hosseini M, Gotfredsen K. A feasible, aesthetic quality evaluation of implant-supported single crowns: an analysis of validity and reliability. Clin Oral Implants Res. 2012 Apr;23(4):453-8. doi: 10.1111/j.1600-0501.2011.02162.x. Epub 2011 Mar 28.

    PubMed 21443589

  • Shiboski SC, Shiboski CH, Criswell L, Baer A, Challacombe S, Lanfranchi H, Schiodt M, Umehara H, Vivino F, Zhao Y, Dong Y, Greenspan D, Heidenreich AM, Helin P, Kirkham B, Kitagawa K, Larkin G, Li M, Lietman T, Lindegaard J, McNamara N, Sack K, Shirlaw P, Sugai S, Vollenweider C, Whitcher J, Wu A, Zhang S, Zhang W, Greenspan J, Daniels T; Sjogren's International Collaborative Clinical Alliance (SICCA) Research Groups. American College of Rheumatology classification criteria for Sjogren's syndrome: a data-driven, expert consensus approach in the Sjogren's International Collaborative Clinical Alliance cohort. Arthritis Care Res (Hoboken). 2012 Apr;64(4):475-87. doi: 10.1002/acr.21591.

    PubMed 22563590

Questions about this trial

What is this clinical trial studying?

A study testing Dental implants in people with Dental Implant and Primary Sjögren Syndrome, run by University of Copenhagen.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Sjögren syndrom (time frame: Five years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04960605, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in