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OPG-RANKL Levels Around Short Implants

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ClinicalTrials.gov Identifier: NCT02840773
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Veli Özgen Öztürk, Aydin Adnan Menderes University

Brief Summary:
The aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.

Condition or disease Intervention/treatment Phase
Implant-abutment Connection Microleakage Short Implant Other: Peri-implanter sulcus fluid sampling Other: Probing depth Other: Crestal bone loss Other: Presence of bleeding on probing Other: Plaque index levels Not Applicable

Detailed Description:
The peri-implant crevicular fluid (PICF) contains several inflammatory mediators; the level of these mediators can provide information on the inflammatory state of the tissue, including the activation of mechanisms of bone destruction. In this context, soluble receptor activator of nuclear factor кB ligand (sRANKL) and osteoprotegerin (OPG) have been suggested as molecular determinants of bone resorption. However, currently, there are only limited studies on the molecular responses of healthy peri-implant tissues following placement of implants on function. The null hypothesis of the present study was that there are no significant differences in the levels of sRANKL and OPG in PICF or in the respective levels of six bacterial species or total bacteria levels in submucosal biofilm samples taken from TIF- and TIS-type implants. Therefore, the aim of the present study was to determine the levels of sRANKL and OPG as well as their relative ratio in PICF surrounding the two different types of implant-abutment connections on short implants after a 12-month monitoring period. Additionally, their association with clinical findings and microbiological markers in plaque samples were assessed in the present study.Thirty short implants were randomly placed in posterior maxillary edentulous sites using a split-mouth design in 15 periodontally healthy subjects. Tapered interference fit (TIF) and taper integrated screwed-in (TIS) types of implant-abutment connections were selected for investigation. PICF and submucosal biofilm samples were collected one month after surgery and repeated 12 months after prosthetic loading. Clinical parameters, including probing depth, dichotomous presence of bleeding on probing, and plaque index, were recorded and digital periapical radiographs were taken at each time point. sRANKL and OPG levels in PICF were analyzed using an enzyme-linked immunosorbent assay. Total bacterial levels, as well as levels of Fusobacterium nucleatum, Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Prevotella intermedia, and Streptococcus oralis, were analyzed in corresponding submucosal biofilm samples using quantitative real-time polymerase chain reaction.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Implant-abutment Connection on Osteoimmunological Parameters in Short Implants: a Randomised Controlled Clinical Trial
Study Start Date : February 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : June 2012

Arm Intervention/treatment
Active Comparator: Test group-baseline
Press-fit implant connection was monitored at baseline
Other: Peri-implanter sulcus fluid sampling
PISF sampling was made twice

Other: Probing depth
The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)

Other: Crestal bone loss
Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Other: Presence of bleeding on probing
The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.

Other: Plaque index levels
The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.

Active Comparator: Test group-12 month
Press-fit implant connection was monitored at 12 month after prosthesis delivered.
Other: Peri-implanter sulcus fluid sampling
PISF sampling was made twice

Other: Probing depth
The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)

Other: Crestal bone loss
Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Other: Presence of bleeding on probing
The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.

Other: Plaque index levels
The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.

Active Comparator: Control group-baseline
Screw-retained connection was monitored at baseline
Other: Peri-implanter sulcus fluid sampling
PISF sampling was made twice

Other: Probing depth
The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)

Other: Crestal bone loss
Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Other: Presence of bleeding on probing
The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.

Other: Plaque index levels
The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.

Active Comparator: Control group-12 month
Screw-retained connection was monitored at 12 month after prosthesis delivered.
Other: Peri-implanter sulcus fluid sampling
PISF sampling was made twice

Other: Probing depth
The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)

Other: Crestal bone loss
Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)

Other: Presence of bleeding on probing
The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.

Other: Plaque index levels
The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.




Primary Outcome Measures :
  1. Peri-implanter sulcus fluid levels of RANKL [ Time Frame: Baseline ]
    Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).

  2. Peri-implanter sulcus fluid levels of RANKL [ Time Frame: 12 month ]
    Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.

  3. Peri-implanter sulcus fluid levels of OPG [ Time Frame: Baseline ]
    Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).

  4. Peri-implanter sulcus fluid levels of OPG [ Time Frame: 12 month ]
    Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading.


Secondary Outcome Measures :
  1. Probing depth [ Time Frame: Baseline ]
    The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.

  2. Probing depth [ Time Frame: 12 month ]
    The level of probing depth at 12 month. Probing depth was measured with a plastic periodontal probe.

  3. Bleeding on probing [ Time Frame: Baseline ]
    The level of clinical parameters bleeding on probing at baseline without prosthetic loading. The presence of bleeding on probing were performed at four sites of implants after 10 sec. of probing.

  4. Bleeding on probing [ Time Frame: 12 month ]
    The level of clinical parameters bleeding on probing at 12 month after prosthetic loading. The presence of bleeding on probing were performed at four sites of implants after 10 sec. of probing.

  5. Plaque index [ Time Frame: Baseline ]
    The level of plaque index at baseline without prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants

  6. Plaque index [ Time Frame: 12 month ]
    The level of plaque index at 12 month after prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants

  7. Crestal bone loss [ Time Frame: Between baseline and 1 year after prosthetic loading ]
    Crestal bone loss measured by digital periapikal radiographs at same time of PISF sampling



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • sufficient bone height for a 6 mm implant and sufficient bone width for a minimum 5.5 mm implant without any augmentation techniques
  • no history of periodontitis.

Exclusion Criteria:

  • Patients with any systemic diseases
  • Smokers were excluded

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): NCT02840773


Locations
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Turkey
Ege University, School of Dentistry, Department of Periodontology
Izmir, Turkey, 35100
Sponsors and Collaborators
Aydin Adnan Menderes University
Investigators
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Principal Investigator: Veli Özgen Öztürk, PhD,DDS Ege University, School of Dentistry, Department of Periodontology
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Responsible Party: Veli Özgen Öztürk, PhD, DDS, Aydin Adnan Menderes University
ClinicalTrials.gov Identifier: NCT02840773    
Other Study ID Numbers: BAP-03-2014
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Veli Özgen Öztürk, Aydin Adnan Menderes University:
RANKL
OPG
Peri-implant crevicular fluid