Assessment of the Accuracy of the Clinical Parameters & Radiographs in Determining the Topography of Implant Bony Lesions

October 4, 2018 updated by: Tan Wah Ching, National Dental Centre, Singapore

Assessment of the Accuracy of the Clinical Parameters and Radiographs in Determining the Topography of Implant Bony Lesions

In recent years, dental implants have gained popularity as the treatment choice for replacement of missing teeth. With this, one of the late biological complications that arise is peri-implantitis. Based on a consensus conference in 2008, peri-implantitis was found in 28% and ≥ 56% of subjects and in 12% and 43% of implant sites (Zitzmann & Berglundh 2008). Detection of peri-implantitis is currently based on clinical parameters like probing depths and radiographic findings of bone loss. There is however no study that assess the variability of clinical probing and radiographic reading in relation to the true outline of the peri-implantitis lesion. The present study will measure variability of clinical probing and radiographs in relation to the true outline of the peri-implantitis lesion, as well as assess the use of 2 different bone substitutes in regenerating the lesions with a barrier membrane.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Identification of peri-implant bony lesions by clinical parameters or radiographs alone may sufficiently reflect the topographical outline of a peri-implant bony lesion. To date, no comparative studies are available that identify the accuracy of clinical parameters or radiographs in outlining the extent and the severity of the lesion. If these parameters are of sufficient accuracy, surgical procedures to regenerate the lesion may be more predictable to plan.

The study population will be patients undergoing regular implant maintenance care in the National Dental Centre Singapore, Periodontics Unit, Department of Restorative Dentistry and yielding peri-implantitis (residual probing depths ≥6mm and bleeding on probing, bone loss of ≥2mm documented on periapical radiographs).

In the first part of the study, the variability of the clinical parameters and periapical radiographs will be assessed and compared to the actual bony lesions revealed after surgical access. This prospective cohort study will encompass 24 subjects. In the second part of the study, a randomised controlled clinical trial will be staged exploring the clinical outcomes of regenerative therapy of the peri-implant lesions applying 2 different bone substitutes with a barrier membrane for the principle of guided bone regeneration (GBR).

First part of study:

The null hypothesis is that of no difference in the mesial and distal radiographic readings as compared to the measurement obtained by clinical probing of the actual peri-implant lesions. The null hypothesis is also that of no difference between probing depth measurements and the actual lesions measured under open access.

Second part of study:

The null hypothesis is that of no difference in clinical outcomes with the use of a synthetic membrane (Guidor®) with a compound of biphasic calcium phosphate, 60 % hydroxyapatite and 40 % beta-tricalcium phosphate (Guidor easy-graft® CRYSTAL) (test) when compared to the same membrane and phase-pure beta-tricalcium phosphate (Guidor easy-graft® CLASSIC ) (control), in GBR of peri- implantitis lesions.

End Points - Efficacy For the subjects, the potential benefits may include improvement in the clinical outcomes.

End Points - Safety The risks involved include complications that may result with all surgeries, i.e., risk of infection, swelling, pain and bruising.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 730770
        • Recruiting
        • National Dental Centre Singapore
        • Contact:
        • Principal Investigator:
          • Marianne Ong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Medically healthy adults (ASA classification I-II), at least 21 years of age.
  2. Diagnosed with peri-implantitis (at least one site with PPD of ≥ 6 mm, a positive bleeding on probing (BOP) and radiographic bone loss of ≥ 2 mm).
  3. Had non-surgical therapy performed previously
  4. Ability to comply with 6-month study follow-up.

Exclusion Criteria:

  1. Medically compromised subjects (ASA classification III-V).
  2. Had not gone through non-surgical therapy
  3. Known allergy or other severe adverse reactions to the synthetic membrane and bone substitutes.
  4. Self declared pregnancy or intend to conceive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test Group
Guidor® and Guidor easy-graft® CRYSTAL Regeneration of the lesion will be performed with a synthetic membrane (Guidor®) with either Guidor easy-graft® CRYSTAL (Test).
Device: Guidor® and Guidor easy-graft® CRYSTAL
A compound of biphasic calcium phosphate, 60 % hydroxyapatite and 40 % beta-tricalcium phosphate. The beta-tricalcium phosphate component completely resorbs via physiological dissolution in 5-15 months, while the interconnected hydroxyapatite remains embedded in the implantation site and forms an integrated long term osteoconductive scaffold with new bone.
Active Comparator: Control Group (C)
Guidor® and Guidor easy-graft® CLASSIC Regeneration of the lesion will be performed with a synthetic membrane (Guidor®) with either Guidor easy-graft® CLASSIC (Test).
Device: Guidor® and Guidor easy-graft® CLASSIC
Phase-pure beta-tricalcium phosphate that offers complete resorption via physiological dissolution in 5-15 months. This material has been used in oral surgery for more than 25 years and there are extensive research available on it.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The accuracy of clinical probing pocket depths to the true outline in peri-implantitis lesions
Time Frame: 6 months after GBR
To determine the accuracy of clinical probing pocket depths (in mm) to the true outline in peri-implantitis lesions
6 months after GBR
The accuracy of peri-apical radiographic readings to the true outline in peri-implantitis lesions
Time Frame: 6 months after GBR
To determine the accuracy of peri-apical radiographic readings (in mm) to the true outline in peri-implantitis lesions
6 months after GBR
Absolute change from baseline of probing pocket depth (PPD in mm) and the degree of bone fill at re-entry (6 months)
Time Frame: 6 months after GBR

- To determine:

  1. Absolute change from baseline of probing pocket depth (PPD in mm) 6 months following GBR therapy in test and control
  2. The degree of bone fill at re-entry (6 months), as well as radiographically (in mm) following GBR
6 months after GBR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Dental Centre, Singapore

Collaborators

Sunstar, Inc.

Investigators

  • Principal Investigator: WAH CHING TAN, National Dental Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2018

Primary Completion (Anticipated)

March 31, 2020

Study Completion (Anticipated)

March 31, 2021

Study Registration Dates

First Submitted

August 21, 2018

First Submitted That Met QC Criteria

October 4, 2018

First Posted (Actual)

October 9, 2018

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 253/2017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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