Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-01-11 @ 6:54 PM
Study NCT ID:
NCT04960605
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2021-06-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome
Sponsor:
University of Copenhagen
Organization:
Study Overview
Official Title:
Prognosis of Dental Implants in Patients With Primary Sjögren's Syndrome. A Prospective Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: