Dental ImplantsNCT02702609

Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System

A study testing easy-graft CLASSIC and FDBA with collagen plug in people with Dental Implants and Alveolar Ridge Preservation, run by Sunstar Americas at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized Controlled study to compare the effectiveness of two different treatment approaches using a new moldable beta-tricalcium phosphate(TCP) bone graft material in ridge preservation of an atraumatic extraction socket site compared to allograft with collagen plug. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dental Implants, Alveolar Ridge Preservation
What is being tested?: easy-graft CLASSIC and FDBA with collagen plug
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 2 sitesUnited States
Study dates: 2 Aug 2016to 19 Aug 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Provision of informed consent
At least 18 years old
In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
Intact ridge as verified with cone-beam CT scan
At least one natural tooth adjacent to the study site present.

Who cannot join

Insufficient interocclusal space to allow for implant supported prosthesis
Dehiscence or fenestration identified at the time of reviewing CBCT.
Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
Adjacent teeth (or tooth) to study site with significant soft tissue loss

Show all 15Show fewer

Smoker using more than 10 cigarettes or equivalent per day
Smokeless tobacco use or e-cigarette use
Current alcohol or drug abuser
Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
Unable or unwilling to return for follow-up visits for a period of 5 months
Unlikely to be able to comply with study procedures according to Investigators judgement
Subject in other clinical trials

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Maryland School of Dentistry
Baltimore, Maryland, 21201
The University of Iowa College of Dentistry
Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket

Conditions: Dental Implants, Alveolar Ridge Preservation
Being tested: easy-graft CLASSIC, FDBA with collagen plug

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

easy-graft CLASSICDevice
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
FDBA with collagen plugDevice
FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.

Study groups in NCT02702609
Study group	Role	What they receive
Moldable beta-TCP grafting system	Experimental	Device: easy-graft CLASSIC (beta-Tricalcium Phosphate) Receives: Device: easy-graft CLASSIC
Allograft	Active comparator	Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug Receives: Device: FDBA with collagen plug

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Measured: Baseline and 4 months post-surgery
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.
Measured: Baseline and 4 months post-surgery

Secondary outcomes (4)

Histomorphometric Assessment of Newly Formed Mineralized Tissue
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of mineralized tissue respective to the percent of the total core area.
Measured: 5 months post-surgery
Histomorphometric Assessment of Residual Bone Graft Particles
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of residual bone graft respective to the percent of the total core area.
Measured: 5 months post-surgery
Histomorphometric Assessment of Non-mineralized Tissue
Bone core biopsy is harvested at the time of implant placement from the "central" part of the ridge at 5 months after ridge preservation procedure. Histomorphometric analysis is performed by one blinded examiner who measured a proportion of non-mineralized tissue respective to the percent of the total core area.
Measured: 5 months post-surgery
Change of Marginal Bone Level Around Dental Implant
Linear measurement of marginal bone level (MBL) in millimeters along mesial and distal dental implant surface are captured in periapical standardized radiographs at crown delivery (baseline), 6, and 12 months after crown delivery. Change of MBL = (Baseline measurement - 6 or 12 months measurement)
Measured: Baseline, 6, and 12 months after crown delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 201619 Aug 2019

First posted8 Mar 2016 (estimated)
Study start2 Aug 2016
Primary completion19 Aug 2019
Study completion19 Aug 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dental ImplantsStudies 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02702609
Sponsor's protocol ID: CLP-2015-12-17-1
Status last verified: Sep 2020
First submitted: 3 Mar 2016
Last updated: 22 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
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The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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All Dental Implants trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Comparative Assessment of Alveolar Ridge Preservation Using GUIDOR® Easy-graft® Classic in Atraumatic Extraction Socket
ClinicalTrials.gov ID: NCT02702609
Acronym / sponsor ID: CLP-2015-12-17-1
Conditions: Dental Implants, Alveolar Ridge Preservation
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Sunstar AmericasIndustry (pharma, biotech, devices)
Study start: 2 Aug 2016 (actual)
Primary completion: 19 Aug 2019 (actual)
Study completion: 19 Aug 2019 (actual)
First posted: 8 Mar 2016 (estimated)
Results: Posted 22 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Moldable beta-TCP grafting system	Experimental	Device: easy-graft CLASSICDevice: easy-graft CLASSIC (beta-Tricalcium Phosphate)
Allograft	Active comparator	Device: FDBA with collagen plugDevice: Freeze-Dried Bone Allograft (FDBA) with collagen plug

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Provision of informed consent
At least 18 years old
In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
Intact ridge as verified with cone-beam CT scan
At least one natural tooth adjacent to the study site present.

Key exclusion criteria (15 listed)

Insufficient interocclusal space to allow for implant supported prosthesis
Dehiscence or fenestration identified at the time of reviewing CBCT.
Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
Adjacent tooth (mesial and distal) to study site was extracted within last 6 months

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
easy-graft CLASSICeasy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.	Device	Moldable beta-TCP grafting system
FDBA with collagen plugFDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.	Device	Allograft

Primary outcome

Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)
Time frame: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Linear measurement of horizontal ridge width is measured at 1 mm apical to the crest. Change of horizontal ridge width = (Baseline measurement - 4 months measurement)
Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)
Time frame: Baseline and 4 months post-surgery
Cone-beam computed tomography (CBCT) is taken at the ridge preservation procedure (baseline) and 4 months after the procedure. Bone volume measurement is expressed in mm3, which allowed for a calculation of the % of volumetric reduction that took place from baseline to 4 months post-surgery.

4 secondary outcomes

Histomorphometric Assessment of Newly Formed Mineralized Tissue
Time frame: 5 months post-surgery
Histomorphometric Assessment of Residual Bone Graft Particles
Time frame: 5 months post-surgery
Histomorphometric Assessment of Non-mineralized Tissue
Time frame: 5 months post-surgery
Change of Marginal Bone Level Around Dental Implant
Time frame: Baseline, 6, and 12 months after crown delivery

Results and safety

Results posted to the registry on 22 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Moldable Beta-TCP Grafting System	24	15
Allograft	21	17

Primary outcome: Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width)

Time frame: Baseline and 4 months post-surgery. Mean (Standard Deviation). Unit: mm

Measure	Moldable Beta-TCP Grafting System n = 23	Allograft n = 20
Value	1.26 (1.32)	1.28 (1.73)

Population analysed: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.

Primary outcome: Change in Radiographic Measurements of Ridge Dimension (Volumetric Assessment)

Time frame: Baseline and 4 months post-surgery. Mean (Standard Deviation). Unit: percentage of volume at baseline

Measure	Moldable Beta-TCP Grafting System n = 23	Allograft n = 20
Value	23.9 (22.1)	17.0 (15.4)

Population analysed: The modified Intent-to-Treat population consisted of 43 subjects after a subject was removed for lack of compliance with the study protocol.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: One year after crown delivery. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moldable Beta-TCP Grafting System	0 of 24 (0%)	2 of 24 (8.3%)	0 of 24
Allograft	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Dental Implants

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Not yet recruiting
Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
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RecruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing easy-graft CLASSIC and FDBA with collagen plug in people with Dental Implants and Alveolar Ridge Preservation, run by Sunstar Americas at 2 sites in United States.

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 5 inclusion and 15 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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

Yes. Results are posted in the registry (first posted 22 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Radiographic Measurements of Ridge Dimension (Horizontal Ridge Width) (time frame: Baseline and 4 months post-surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02702609.

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 22 Oct 2020.