NCT02840773

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2016

Completed
Last Updated

July 21, 2016

Status Verified

July 1, 2016

Enrollment Period

1.9 years

First QC Date

June 10, 2016

Last Update Submit

July 20, 2016

Conditions

Implant-abutment ConnectionMicroleakageShort Implant

Keywords

RANKLOPGPeri-implant crevicular fluid

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (7)

  • Probing depth

    Baseline

  • Probing depth

    12 month

  • Bleeding on probing

    Baseline

  • Bleeding on probing

    12 month

  • Plaque index

    Baseline

  • +2 more secondary outcomes

Study Arms (4)

Test group-baseline

ACTIVE COMPARATOR

Press-fit implant connection was monitored at baseline

Other: Peri-implanter sulcus fluid samplingOther: Probing depthOther: Crestal bone lossOther: Presence of bleeding on probingOther: Plaque index levels

Test group-12 month

ACTIVE COMPARATOR

Press-fit implant connection was monitored at 12 month after prosthesis delivered.

Other: Peri-implanter sulcus fluid samplingOther: Probing depthOther: Crestal bone lossOther: Presence of bleeding on probingOther: Plaque index levels

Control group-baseline

ACTIVE COMPARATOR

Screw-retained connection was monitored at baseline

Other: Peri-implanter sulcus fluid samplingOther: Probing depthOther: Crestal bone lossOther: Presence of bleeding on probingOther: Plaque index levels

Control group-12 month

ACTIVE COMPARATOR

Screw-retained connection was monitored at 12 month after prosthesis delivered.

Other: Peri-implanter sulcus fluid samplingOther: Probing depthOther: Crestal bone lossOther: Presence of bleeding on probingOther: Plaque index levels

Interventions

Peri-implanter sulcus fluid samplingOTHER

PISF sampling was made twice

Control group-12 monthControl group-baselineTest group-12 monthTest group-baseline
Probing depthOTHER

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

Control group-12 monthControl group-baselineTest group-12 monthTest group-baseline
Crestal bone lossOTHER

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)

Control group-12 monthControl group-baselineTest group-12 monthTest group-baseline
Presence of bleeding on probingOTHER

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.

Control group-12 monthControl group-baselineTest group-12 monthTest group-baseline
Plaque index levelsOTHER

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.

Control group-12 monthControl group-baselineTest group-12 monthTest group-baseline

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with any systemic diseases
  • Smokers were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University, School of Dentistry, Department of Periodontology

Izmir, 35100, Turkey (Türkiye)

Location

Study Officials

  • Veli Özgen Öztürk, PhD,DDS

    Ege University, School of Dentistry, Department of Periodontology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, DDS

Study Record Dates

First Submitted

June 10, 2016

First Posted

July 21, 2016

Study Start

February 1, 2010

Primary Completion

January 1, 2012

Study Completion

June 1, 2012

Last Updated

July 21, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will share

Locations

TU(1)