Peri-ImplantitisNCT03698851
Assessment of the Accuracy of the Clinical Parameters & Radiographs in Determining the Topography of Implant Bony Lesions
A study testing Guidor® and Guidor easy-graft® CRYSTAL and Guidor® and Guidor easy-graft® CLASSIC in people with Peri-Implantitis, run by National Dental Centre, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Guidor® and Guidor easy-graft® CRYSTAL and Guidor® and Guidor easy-graft® CLASSIC
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Mar 2018to 22 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peri-Implantitis
- Being tested
- Guidor® and Guidor easy-graft® CRYSTAL, Guidor® and Guidor easy-graft® CLASSIC
- Keywords
- Peri-Implantitis lesion, Dental Implants
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guidor® and Guidor easy-graft® CRYSTALDevice
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.
Guidor® and Guidor easy-graft® CLASSICDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | 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). Receives: Device: Guidor® and Guidor easy-graft® CRYSTAL |
| Control Group (C) | Active comparator | 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). Receives: Device: Guidor® and Guidor easy-graft® CLASSIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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:
- Absolute change from baseline of probing pocket depth (PPD in mm) 6 months following GBR therapy in test and control
- The degree of bone fill at re-entry (6 months), as well as radiographically (in mm) following GBR
Measured: 6 months after GBR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2018
- Study start2 Mar 2018
- Primary completion22 Nov 2024
- Study completion22 Nov 2024
Why it stopped: Study was terminated due to the difficulty in identifying suitable participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Dental Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Sunstar, Inc.
- Responsible party
- Principal investigator, Tan Wah Ching, National Dental Centre, Singapore
- Investigators
- WAH CHING TAN, Principal investigator, National Dental Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03698851
- Sponsor's protocol ID
- 253/2017
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2018
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of the Clinical Parameters and Radiographs in Determining the Topography of Implant Bony Lesions
- ClinicalTrials.gov ID
- NCT03698851
- Acronym / sponsor ID
- 253/2017
- Conditions
- Peri-Implantitis
- Keywords
- Peri-Implantitis lesion, Dental Implants
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated due to the difficulty in identifying suitable participants.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- National Dental Centre, SingaporeUniversity, hospital or other
- Collaborators
- Sunstar, Inc.
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 22 Nov 2024 (actual)
- Study completion
- 22 Nov 2024 (actual)
- First posted
- 9 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Device: Guidor® and Guidor easy-graft® CRYSTALGuidor® 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 comparator | Device: Guidor® and Guidor easy-graft® CLASSICGuidor® and Guidor easy-graft® CLASSIC Regeneration of the lesion will be performed with a synthetic membrane (Guidor®) with either Guidor easy-graft® CLASSIC (Test). |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guidor® and Guidor easy-graft® CRYSTALA 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. | Device | Test Group |
| Guidor® and Guidor easy-graft® CLASSICPhase-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. | Device | Control Group (C) |
Primary outcome
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
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
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
Results and safety
The study was stopped early (reason given: Study was terminated due to the difficulty in identifying suitable participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WAH CHING TAN principal investigator
National Dental Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guidor® and Guidor easy-graft® CRYSTAL and Guidor® and Guidor easy-graft® CLASSIC in people with Peri-Implantitis, run by National Dental Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was terminated due to the difficulty in identifying suitable participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of clinical probing pocket depths to the true outline in peri-implantitis lesions (time frame: 6 months after GBR). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.