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Outcome After Dental Implant Treatment

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ClinicalTrials.gov Identifier: NCT02671812
Recruitment Status : Completed
First Posted : February 2, 2016
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Lottie Adler, Folktandvården Stockholms län AB

Brief Summary:
The general aim of this project is to investigate the long-term treatment outcome after implant therapy. The patients' satisfaction with implant treatment will be studied and correlated to biological and technical problems. The survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants will be calculated. The levels of cytokines and bone loss markers in peri-implantitis sites and periodontal defects and at healthy sites will be analyzed in order to study the correlation between cytokine and bone loss marker levels, and clinical conditions. Independent variables which could be regarded as significant risk factors or risk predictors on the incidence of peri-implantitis are aimed to be identified

Condition or disease
PROMs Peri-implantitis Mucositis Periodontitis

Detailed Description:
  • A questionnaire study will investigate patient satisfaction 8-14 years after dental implant therapy to study if complications influence the degree of satisfaction/quality of life. The questionnaire will be sent to 587 patients treated at The Specialist Clinic Skanstull.
  • A clinical examination of a minimum 150 patients who answered the questionnaire will be performed:
  • to study the incidence of biological and technical complications on dental implants after a minimum of 10 year of function.
  • to study the survival rates of implants at patient level and the degree of bone loss of remaining teeth and implants. In addition, the correlation between bone loss of remaining teeth and bone loss of implants will be studied.
  • samples taken from the gingival crevicular fluid to investigate the profile of cytokines and bone resorption markers as well as to study the intra-individual correlation of cytokines and bone markers in gingival crevicular fluid from sites with peri-implantitis and periodontal defects in individuals with dental implants.
  • in addition, the salivary cytokine and bone resorption markers will be analyzed in order to identify disease-specific biomarkers as well as to study the correlation between the cytokine/bone resorption markers in saliva and in gingival/peri-implant crevicular fluid.
  • To identify significant risk factors or risk predictors on the incidence of peri-implantitis.

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Study Type : Observational
Actual Enrollment : 163 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Longterm Outcome After Dental Implant Treatment
Actual Study Start Date : November 27, 2014
Actual Primary Completion Date : August 2018
Actual Study Completion Date : August 2018



Primary Outcome Measures :
  1. Patients satisfaction after dental implant treatment [ Time Frame: 10 years after implant treatment ]
    Questionnaire and clinical examination


Secondary Outcome Measures :
  1. Complications prevalence [ Time Frame: 10 years after implant treatment ]
    Self reported and registered in patients journal and detected at the clinical examination

  2. Profile of inflamatory markers [ Time Frame: 10 years after implant treatment ]
    Samples of saliva and gingival fluid from healthy and disease sites at both tooth and dental implants will be analyzed


Biospecimen Retention:   Samples With DNA
Saliva and gingival fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients treated with dental implants at the Specialist Clinic Skanstull, Stockholm, Sweden, between 1999-2005
Criteria

Inclusion Criteria:

- Treated at the Specialist Clinic Skanstull, Stockholm, Sweden with dental implants between the years of 1999-2005

Exclusion Criteria:

- Deceased before or during the study period


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671812


Sponsors and Collaborators
Folktandvården Stockholms län AB
Karolinska Institutet
Investigators
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Study Director: Margaret Sällberg Chen, Assc. Prof Karolinska Institutet Odontologen
Publications of Results:
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Responsible Party: Lottie Adler, DDS PhD-student, Folktandvården Stockholms län AB
ClinicalTrials.gov Identifier: NCT02671812    
Other Study ID Numbers: OF13122003
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lottie Adler, Folktandvården Stockholms län AB:
dental implant
patient satisfaction
treatment outcome
cytokine profile
risk factor
risk predictor
Additional relevant MeSH terms:
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Mucositis
Periodontitis
Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases