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

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ClinicalTrials.gov Identifier: NCT03698851
Recruitment Status : Unknown
Verified October 2018 by Tan Wah Ching, National Dental Centre, Singapore.
Recruitment status was:  Recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Collaborator:
Sunstar, Inc.
Information provided by (Responsible Party):
Tan Wah Ching, National Dental Centre, Singapore

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Peri-Implantitis Device: Guidor® and Guidor easy-graft® CRYSTAL Device: Guidor® and Guidor easy-graft® CLASSIC Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Assessment of the Accuracy of the Clinical Parameters and Radiographs in Determining the Topography of Implant Bony Lesions
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698851


Contacts
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Contact: EDWIN LIU 63248879 edwin.liu.w.y@ndcs.com.sg
Contact: QI XIN NG 63248754 ng.qi.xin@singhealth.com.sg

Locations
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Singapore
National Dental Centre Singapore Recruiting
Singapore, Singapore, 730770
Contact: WAH CHING TAN    63248754    tan.wah.ching@ndcs.com.sg   
Principal Investigator: Marianne Ong         
Sponsors and Collaborators
National Dental Centre, Singapore
Sunstar, Inc.
Investigators
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Principal Investigator: WAH CHING TAN National Dental Centre, Singapore
More Information
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Responsible Party: Tan Wah Ching, Dr, Visiting Specialist (Peridontics), Department of Restorative Dentistry, National Dental Centre, Singapore
ClinicalTrials.gov Identifier: NCT03698851    
Other Study ID Numbers: 253/2017
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tan Wah Ching, National Dental Centre, Singapore:
Peri-Implantitis lesion
Dental Implants
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
 Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors