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

NCT04960605 | Completed DMC

• 1 other identifier: 1036_2015
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dental Implant; Primary Sjögren Syndrome

Keywords

Dental Implants; Primary Sjögren syndrom; Biological outcome; Technical outcome; Aesthetic outcome; Patient-reported outcome

Outcome Measures

Primary Outcomes (9)

• Number of patients with Sjögren syndrom

  number of participants in the test group

  Five years

• Number of patients without Sjögren syndrom

  number of participants in the control group

  Five years

• Number of implants in each group

  number of implants in patients with or without Sjögren syndrom

  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

  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.

  5 year

• Sialometry

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

  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

  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)

  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).

  5 years

Secondary Outcomes (3)

• Decayed, Missing, Filled Tooth index (DMFT)

  5 years

• Modified Plaque Index

  5 years

• Modified Mucosal Index scores

  5 years

Study Arms (2)

Test group

OTHER

Patients with Primary Sjögren Syndrom

Procedure: Dental implants

Control group

OTHER

Patients with Primary Sjögren Syndrom, matched to the test group

Procedure: Dental implants

Interventions

Dental implants PROCEDURE

Treatment of the toothless regions with dental implants

Control group; Test group

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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)
• The items:
• 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?

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead
• ITI Foundation: collaborator
• Gigtforeningen: collaborator
• Rigshospitalet, Denmark: collaborator

Related Publications (4)

• 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.

  PMID: 10531746 RESULT

• 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.

  PMID: 15740617 RESULT

• 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.

  PMID: 21443589 RESULT

• 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.

  PMID: 22563590 RESULT

MeSH Terms

Interventions

Dental Implants

Intervention Hierarchy (Ancestors)

Dental Materials; Biomedical and Dental Materials; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Mandana Hosseini

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistical analyses will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guest researcher

Model Details: Prospective study

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 14, 2021
• Study Start: January 1, 2015
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share