OPG-RANKL Levels Around Short Implants

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

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.

Study Overview

• Status: Completed
• Conditions: Implant-abutment Connection; Microleakage; Short Implant
• Intervention / Treatment: Other: Peri-implanter sulcus fluid sampling; Other: Probing depth; Other: Crestal bone loss; Other: Presence of bleeding on probing; Other: Plaque index levels

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Izmir, Turkey, 35100
    • Ege University, School of Dentistry, Department of Periodontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Aydin Adnan Menderes University
• Investigators: Principal Investigator: Veli Özgen Öztürk, PhD,DDS, Ege University, School of Dentistry, Department of Periodontology

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): June 1, 2012

Study Registration Dates

• First Submitted: June 10, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 21, 2016

Study Record Updates

• Last Update Posted (Estimate): July 21, 2016
• Last Update Submitted That Met QC Criteria: July 20, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: OPG; RANKL; Peri-implant crevicular fluid
• Other Study ID Numbers: BAP-03-2014

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES