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Completed

NCT Number: NCT02840773

OPG-RANKL Levels Around Short Implants

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.

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Key information

Conditions

Implant-abutment Connection Microleakage Short Implant

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ege University, School of Dentistry, Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peri-implanter sulcus fluid sampling

Other

PISF sampling was made twice

Probing depth

Other

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

Crestal bone loss

Other

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)

Presence of bleeding on probing

Other

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.

Plaque index levels

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aydin Adnan Menderes University

Other

Registry information

Official study title

Impact of Implant-abutment Connection on Osteoimmunological Parameters in Short Implants: a Randomised Controlled Clinical Trial

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 21, 2016
Registry last updated
Jul 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.