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Cement Excess at Single Implant Crowns Malmö/Lund

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ClinicalTrials.gov Identifier: NCT04015427
Recruitment Status : Recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Fölktandvården Skåne AB
Göteborg University
Dentsply Sirona Implants
Information provided by (Responsible Party):
University of Zurich

Brief Summary:

Abstract

Aim:

The primary aim of this study is to test whether or not cement residues in the submucosal environment of implants lead to a change in the microbiota and induce inflammation of the periimplant tissues.

Material and Methods:

24 patients in need of a single tooth replacement will be enrolled in this cross-over controlled clinical study. All patients will receive a two-piece dental implant, which will be restored with both a cemented and a screw-retained single crown. At the time of impression taking, patients will be randomized into two groups.

Patients in group A will receive a screw-retained crown. Every 8 weeks microbiological samples using sterile paper points will be collected and analyzed for bacterial content by real-time PCR. Additionally, two host markers (MMP8, IL-1ß) will be determined by ELISA. Following this first period of 16 weeks, the screw-retained crown will be replaced by a new intraorally cemented crown. Cement removal will be preformed according to best clinical procedure. These crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.

In group B the crowns will be incorporated in a reverse pattern. During the first 16 weeks any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.

After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.


Condition or disease Intervention/treatment Phase
Gingivitis and Periodontal Diseases Tooth Loss Device: implant crown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical, Microbiological and Histological Effects of Cemented Implant Restorations. A Cross-over Controlled Clinical Study
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
Active Comparator: screw-retained
Patients in group A will receive a screw-retained implant crown. Following this first period of 16 weeks, the screw-retained implant crown will be replaced by a new intraorally cemented implant crown. Cement removal will be preformed according to best clinical procedure. These implant crowns will again be left for another period of 16 weeks and followed up for the harvesting of microbiological samples every 8 weeks. After the second 16-week the implant crowns will be removed to evaluate any excess cement. All patients will be fitted with the original screw-retained implant crown. Clinical parameters for inflammation and probing depths will be obtained after each 16 week-period.
Device: implant crown
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.

Active Comparator: cement-retained
In group B the implant crowns will be incorporated in a reverse pattern. During the first 16 weeks a cemented implant crown will be inserted and any possible cement residues will be removed according to best clinical procedure, while for the second period of 16 weeks patients will be fitted with a screw-retained single implant crown. Again, microbiological and clinical parameters will be obtained at the same intervals as in Group A.
Device: implant crown
After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.




Primary Outcome Measures :
  1. Analysis of microbiological parameters [ Time Frame: Change BL to 16 weeks post-restoration ]
    Change relative percentage of gram-negative microorganisms


Secondary Outcome Measures :
  1. Histomorphometric analysis [ Time Frame: 32 weeks after BL ]
    A soft tissue biopsy will be harvested at the time of insertion of the final screw-retained implant crown in all patients. The biopsies will be used for histomorphometric measurements.

  2. Immunohistologic analysis - putative periodontal pathogens [ Time Frame: 32 weeks after BL ]
    The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips. A battery of 10 putative periodontal pathogens will be analyzed using real-time PCR.

  3. Immunohistologic analysis - MMP8 [ Time Frame: 32 weeks after BL ]
    The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips.

  4. Immunohistologic analysis - IL1ß [ Time Frame: 32 weeks after BL ]
    The biopsies will be used for the determination of inflammation and infection markers applying light-microscopy. Gingival crevicular fluid (GCF) will be collected using standardized filter paper strips.

  5. Analysis of inflammation markers on RNA-basis - (IL-4, IL-3, IL-1alfa, IL-1beta) [ Time Frame: 32 weeks after BL ]
    Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa).

  6. Analysis of inflammation markers on RNA-basis - TNF-alfa [ Time Frame: 32 weeks after BL ]
    Tissue samples will further be processed with a (ribonucleic acid) RNA solution to allow for RNA extraction. This will then be analyzed via polymerase chain reaction (PCR) to determine expression patterns of markers such as Interleukin (IL-4, IL-3, IL-1alfa, IL-1beta) and tumor necrose factor (TNF-alfa).

  7. Clinical parameters - Probing Depth [ Time Frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up ]
    In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)

  8. Clinical parameters - Bleeding-on-Probing [ Time Frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up ]
    In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)

  9. Clinical parameters - Plaque Index [ Time Frame: Every 8 weeks until 48 weeks and again at the 1-year follow-up ]
    In order to assess the inflammatory status of the peri-implant tissue, different parameters will be assessed: 1) plaque index (dichotomous values) 2) keratinized tissue width (continuous) 3) BOP (dichotomous), 4) PD (continuous), 5) recession (continuous)


Other Outcome Measures:
  1. Determination of additional inflammatory markers - MMP8 [ Time Frame: 4 times 8 weeks ]
    The collected microbiological samples will additionally be analyzed for two host markers (MMP8, IL-1ß) that will be determined by ELISA.

  2. Determination of additional inflammatory markers - IL-1ß [ Time Frame: 4 times 8 weeks ]
    The collected microbiological samples will additionally be analyzed for two host markers (MMP8, IL-1ß) that will be determined by ELISA.

  3. Radiological outcomes [ Time Frame: 12 weeks pre-BL, BL and 1year post-BL ]
    A single-tooth x-ray will be obtained at the time of implant placement and again at abutment connection in order to ensure sufficient osseointegration of the implant before entering the prosthetic phase. At the time of insertion of the respective reconstruction in both groups, another periapical radiograph will be obtained to ensure the fit of the reconstruction and to check for eventual cement residue. A final x-ray will be taken at insertion of the final screw-retained implant crown to serve as baseline regarding marginal bone level at the time of final crown insertion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • - patient older than 18 years
  • systemically healthy subject
  • periodontally healthy individuals
  • absence of peri-implantitis
  • no bone loss
  • good oral hygiene (PCR ≤ 20%)
  • healthy periodontal tissues (BoP≤ 20%)
  • patients with a single tooth gap in the posterior area of either jaw (premolars and molars)
  • at least 8mm in mandible; at least 6mm in maxilla (summers technique)

Exclusion Criteria:

  • - ongoing periodontal disease
  • bruxism
  • unwilling to comply with study procedures
  • heavy smokers (≥10 cig/d)
  • ongoing periodontitis/implantitis

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): NCT04015427


Contacts
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Contact: nadja naenni, Dr.med.ent 0041 044 634 34 50 nadja.naenni@zzm.uzh.ch
Contact: stephanie mathes, Dr.rer.nat. 0041 044 634 33 65 stephanie.mathes@zzm.uzh.ch

Locations
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Sweden
Folktandvården Skåne Recruiting
Lund, Skåne, Sweden
Contact: Björn Gjelvold, DDS    0771-55 88 00    bjorn.gjelvold@folktandvardenskane.se   
Sponsors and Collaborators
University of Zurich
Fölktandvården Skåne AB
Göteborg University
Dentsply Sirona Implants
  Study Documents (Full-Text)

Documents provided by University of Zurich:
Study Protocol  [PDF] May 4, 2018


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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04015427     History of Changes
Other Study ID Numbers: 2018-414
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

the scans of the sealed randomization envelopes will be sent to the center in Lund, Sweden whenever a patient is included and ready to take the impression.

A folder structure on switch drive is set up with the Subject numbers (1-24) in order to upload the CRFs, photographs and X rays.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: mid 2020
Access Criteria: login provided by the study monitor (UZH)
URL: http://drive.switch.ch

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Zurich:
cement
dental
implant
implant prosthodontics

Additional relevant MeSH terms:
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Periodontal Diseases
Gingivitis
Tooth Loss
Mouth Diseases
Stomatognathic Diseases
Gingival Diseases
Tooth Diseases