OPG-RANKL Levels Around Short Implants

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Implant-abutment Connection, Microleakage, Short Implant

Intervention / Treatment
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* Other: Peri-implanter sulcus fluid sampling
* Other: Probing depth
* Other: Crestal bone loss
* Other: Presence of bleeding on probing
* Other: Plaque index levels


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Test group-baseline<br>Press-fit implant connection was monitored at baseline | Other: Peri-implanter sulcus fluid sampling<br>* PISF sampling was made twice<br>Other: Probing depth<br>* The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Crestal bone loss<br>* 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)<br>Other: Presence of bleeding on probing<br>* 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.<br>Other: Plaque index levels<br>* 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.<br>|
| Active Comparator: Test group-12 month<br>Press-fit implant connection was monitored at 12 month after prosthesis delivered. | Other: Peri-implanter sulcus fluid sampling<br>* PISF sampling was made twice<br>Other: Probing depth<br>* The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Crestal bone loss<br>* 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)<br>Other: Presence of bleeding on probing<br>* 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.<br>Other: Plaque index levels<br>* 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.<br>|
| Active Comparator: Control group-baseline<br>Screw-retained connection was monitored at baseline | Other: Peri-implanter sulcus fluid sampling<br>* PISF sampling was made twice<br>Other: Probing depth<br>* The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Crestal bone loss<br>* 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)<br>Other: Presence of bleeding on probing<br>* 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.<br>Other: Plaque index levels<br>* 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.<br>|
| Active Comparator: Control group-12 month<br>Screw-retained connection was monitored at 12 month after prosthesis delivered. | Other: Peri-implanter sulcus fluid sampling<br>* PISF sampling was made twice<br>Other: Probing depth<br>* The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)<br>Other: Crestal bone loss<br>* 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)<br>Other: Presence of bleeding on probing<br>* 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.<br>Other: Plaque index levels<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri-implanter sulcus fluid levels of RANKL | Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading). | Baseline | 
| Peri-implanter sulcus fluid levels of RANKL | Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading. | 12 month | 
| Peri-implanter sulcus fluid levels of OPG | Peri-implanter sulcus fluid were sampled at baseline (without prosthetic loading). | Baseline | 
| Peri-implanter sulcus fluid levels of OPG | Peri-implanter sulcus fluid were sampled at 1 year after prosthetic loading. | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing depth | The level of probing depth at baseline. Probing depth was measured with a plastic periodontal probe. | Baseline | 
| Probing depth | The level of probing depth at 12 month. Probing depth was measured with a plastic periodontal probe. | 12 month | 
| Bleeding on probing | 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. | Baseline | 
| Bleeding on probing | 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. | 12 month | 
| Plaque index | The level of plaque index at baseline without prosthetic loading. The dichotomous presence of supra gingival plaque was recorded at four sites of implants | Baseline | 
| Plaque index | 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 | 12 month | 
| Crestal bone loss | Crestal bone loss measured by digital periapikal radiographs at same time of PISF sampling | Between baseline and 1 year after prosthetic loading | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RANKL, OPG, Peri-implant crevicular fluid