Study Stopped
Study was terminated due to the difficulty in identifying suitable participants.
Assessment of the Accuracy of the Clinical Parameters & Radiographs in Determining the Topography of Implant Bony Lesions
1 other identifier
interventional
4
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 2, 2018
CompletedFirst Submitted
Initial submission to the registry
August 21, 2018
CompletedFirst Posted
Study publicly available on registry
October 9, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 22, 2024
CompletedJanuary 3, 2025
January 1, 2025
6.7 years
August 21, 2018
January 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The accuracy of clinical probing pocket depths to the true outline in peri-implantitis lesions
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
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)
\- 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
Study Arms (2)
Test Group
EXPERIMENTALGuidor® and Guidor easy-graft® CRYSTAL Regeneration of the lesion will be performed with a synthetic membrane (Guidor®) with either Guidor easy-graft® CRYSTAL (Test).
Control Group (C)
ACTIVE COMPARATORGuidor® and Guidor easy-graft® CLASSIC Regeneration of the lesion will be performed with a synthetic membrane (Guidor®) with either Guidor easy-graft® CLASSIC (Test).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Medically healthy adults (ASA classification I-II), at least 21 years of age.
- 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).
- Had non-surgical therapy performed previously
- Ability to comply with 6-month study follow-up.
You may not qualify if:
- Medically compromised subjects (ASA classification III-V).
- Had not gone through non-surgical therapy
- Known allergy or other severe adverse reactions to the synthetic membrane and bone substitutes.
- Self declared pregnancy or intend to conceive.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Dental Centre, Singaporelead
- Sunstar, Inc.collaborator
Study Sites (1)
National Dental Centre Singapore
Singapore, 730770, Singapore
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
WAH CHING TAN
National Dental Centre, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr, Visiting Specialist (Peridontics), Department of Restorative Dentistry
Study Record Dates
First Submitted
August 21, 2018
First Posted
October 9, 2018
Study Start
March 2, 2018
Primary Completion
November 22, 2024
Study Completion
November 22, 2024
Last Updated
January 3, 2025
Record last verified: 2025-01