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OPG-RANKL Levels Around Short Implants

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02840773
Enrollment
15
Registered
2016-07-21
Start date
2010-02-28
Completion date
2012-06-30
Last updated
2016-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implant-abutment Connection, Microleakage, Short Implant

Keywords

RANKL, OPG, Peri-implant crevicular fluid

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.

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.

Interventions

OTHERPeri-implanter sulcus fluid sampling

PISF sampling was made twice

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 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)

OTHERPresence 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.

OTHERPlaque 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.

Sponsors

Aydin Adnan Menderes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Peri-implanter sulcus fluid levels of RANKLBaselinePeri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).
Peri-implanter sulcus fluid levels of OPGBaselinePeri-implanter sulcus fluid were sampled at baseline (without prosthetic loading).

Secondary

MeasureTime frameDescription
Probing depthBaselineThe level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe.
Bleeding on probingBaselineThe 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.
Plaque indexBaselineThe level of plaque index at baseline without prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants
Crestal bone lossBetween baseline and 1 year after prosthetic loadingCrestal bone loss measured by digital periapikal radiographs at same time of PISF sampling

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026