Dental Implant Failure NosPhase 3CATERNCT04082143
CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
A Phase 3 study testing Allograft mucosal enhancement with dental implant and No allograft mucosal enhancement at time of dental implant placement in people with Dental Implant Failure Nos, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Failure Nos
- What is being tested?
- Allograft mucosal enhancement with dental implant and No allograft mucosal enhancement at time of dental implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2019to 20 Dec 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Willing and able to provide informed consent
- In need of one implant to replace a missing tooth
- At least 20 teeth in good repair and occlusion
- Sufficient bone volume for dental implant placement without required bone augmentation
- Site development (soft and/or bone tissue) performed at least 5 months before implant placement, when required
Who cannot join
- Current smoker
- Implant cannot be placed without bone graft
- Unable to pay for crown
- Untreated rampant caries and/or uncontrolled periodontitis
- Absence of adjacent (mesial and/or distal) natural tooth
- Uncontrolled diabetes
Show all 13Show fewer
- Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration
- use of bisphosphonates
- History of radiation in the head and neck region
- Unable or unwilling to return for follow-up visits
- Unrealistic esthetic or functional demands
- Unlikely to be able to comply with study procedures
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago College of Dentistry
Chicago, Illinois, 60611
About this study
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum graft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic at 1 year after implant placement for implant evaluation. At this final study appointment, x-rays and a 3D intraoral scan will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be assessed via bleeding upon probing and completion of a brief questionnaire, respectively.
Read the detailed description
An alveolar ridge is the part of the jawbone which immediately surrounds and anchors the tooth socket ("alveolus"). Similar to any bone or muscle atrophying when not used, the alveolar ridge will shrink ("resorb") following tooth extraction. The volume of an alveolar ridge can be measured by both 3 Dimensional ("3D") intraoral scan and radiography, and is used clinically as a metric of oral health.
A dental implant is a medical-grade titanium screw placed into healed alveolar bone or a tooth socket following tooth extraction. It replaces the tooth root and supports the crown, or "dental cap"; an artificial tooth generally made with porcelain or surgical grade metals.
Implant success requires both sufficient bone alveolar volume and sufficient mucosal tissue to protect against biofilm-mediated inflammation, assure functional comfort and contribute to dental implant esthetics. Following dental implant placement, the alveolar ridge resorbs approximately 0.5 to 1.0 mm during the first year. Healed ridges are also often volumetrically deficient, losing up to 30% of their horizontal volume following tooth extraction.
To remedy this, peri-implant mucosal grafting has been proposed and is currently part of dental implant therapy. Both autogenous grafts (mucosal connective tissue from the roof of the patient's own mouth or "palate") and allogeneic grafts (collagen-rich grafts derived from a genetically non-identical human donor) are used for these purposes, but there is controversy regarding the effectiveness of supplemental graft use during implant treatment.
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum allograft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic about 1 year after implant placement for assessment of the implant evaluation. At this final study appointment, x-rays, a 3D intraoral scan and intraoral photographs of the implant will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be measured via bleeding upon probing and completion of a brief questionnaire, respectively.
- Conditions
- Dental Implant Failure Nos
- Being tested
- Allograft mucosal enhancement with dental implant, No allograft mucosal enhancement at time of dental implant placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allograft mucosal enhancement with dental implantDevice
implant placement with allograft mucosal enhancement
No allograft mucosal enhancement at time of dental implant placementDevice
implant placement without allograft mucosal enhancement
| Study group | Role | What they receive |
|---|---|---|
| Implant with prophylactic allograft | Experimental | Implant placement will be performed with simultaneous placement of the allograft. Receives: Device: Allograft mucosal enhancement with dental implant |
| Implant without prophylactic allograft | Active comparator | Implant placement will be performed without a graft Receives: Device: No allograft mucosal enhancement at time of dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning
Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning
Measured: 12 months post implant surgery
Secondary outcomes (3)
Percentage of Implant Survival
Implant survival at 12 months post implant surgery. Percentage of implants surviving after 12 months of placement
Measured: 12 months post implant surgery
Marginal Bone Levels (MBLs)
Marginal bone levels (in millimeters) as measured by radiographic translucency. Bone levels between implant/abutment interface and crest of the bone were measured at time of implant placement and at 12 months later. The negative sign in the results below indicates that there was bone loss in both groups.
Measured: 12 months post implant surgery
Vertical Tissue Change as Measured by 3D Intraoral Scanning
This measurement is for the vertical position of the gingival margin change based on superimposed 3D intraoral scans
Measured: 12 months post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start25 Aug 2019
- Primary completion1 Jul 2022
- Study completion20 Dec 2022
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 Implant Failure NosStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- subjects will be randomized to one of two groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Responsible party
- Principal investigator, Sandra Al-Tarawneh, University of Illinois Chicago
- Investigators
- Sandra Al-Tarawneh, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082143
- Sponsor's protocol ID
- 2019-0255
- Acronym
- CATER
- Status last verified
- Feb 2025
- First submitted
- 5 Sep 2019
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CATER: Comprehensive Alveolar and Tooth Esthetic Replacement
- ClinicalTrials.gov ID
- NCT04082143
- Acronym / sponsor ID
- CATER / 2019-0255
- Conditions
- Dental Implant Failure Nos
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Dentsply Sirona Implants and Consumables
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Posted 28 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum graft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic at 1 year after implant placement for implant evaluation. At this final study appointment, x-rays and a 3D intraoral scan will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be assessed via bleeding upon probing and completion of a brief questionnaire, respectively.
Detailed description
An alveolar ridge is the part of the jawbone which immediately surrounds and anchors the tooth socket ("alveolus"). Similar to any bone or muscle atrophying when not used, the alveolar ridge will shrink ("resorb") following tooth extraction. The volume of an alveolar ridge can be measured by both 3 Dimensional ("3D") intraoral scan and radiography, and is used clinically as a metric of oral health.
A dental implant is a medical-grade titanium screw placed into healed alveolar bone or a tooth socket following tooth extraction. It replaces the tooth root and supports the crown, or "dental cap"; an artificial tooth generally made with porcelain or surgical grade metals.
Implant success requires both sufficient bone alveolar volume and sufficient mucosal tissue to protect against biofilm-mediated inflammation, assure functional comfort and contribute to dental implant esthetics. Following dental implant placement, the alveolar ridge resorbs approximately 0.5 to 1.0 mm during the first year. Healed ridges are also often volumetrically deficient, losing up to 30% of their horizontal volume following tooth extraction.
To remedy this, peri-implant mucosal grafting has been proposed and is currently part of dental implant therapy. Both autogenous grafts (mucosal connective tissue from the roof of the patient's own mouth or "palate") and allogeneic grafts (collagen-rich grafts derived from a genetically non-identical human donor) are used for these purposes, but there is controversy regarding the effectiveness of supplemental graft use during implant treatment.
The purpose of this study is to prospectively evaluate whether including an allogeneic gum graft (PerioDerm*) during dental implant therapy improves implant health and appearance.
On the day of implant surgery, participating subjects will be randomized to either receive or not receive a supplemental gum allograft along with the implant. Participating subjects will also be asked to complete a brief (about 15 questions) oral health questionnaire.
Participating subjects will return to the clinic about 8 weeks post surgery for digital crown impressions and again at 11-13 weeks after surgery for crown placement. Participating subjects will also return to clinic about 1 year after implant placement for assessment of the implant evaluation. At this final study appointment, x-rays, a 3D intraoral scan and intraoral photographs of the implant will be obtained for the purpose of measuring alveolar volume. The health of the mucosa surrounding the implant and subject satisfaction will be measured via bleeding upon probing and completion of a brief questionnaire, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- subjects will be randomized to one of two groups
| Arm | Type | Receives |
|---|---|---|
| Implant with prophylactic allograft | Experimental | Device: Allograft mucosal enhancement with dental implantImplant placement will be performed with simultaneous placement of the allograft. |
| Implant without prophylactic allograft | Active comparator | Device: No allograft mucosal enhancement at time of dental implant placementImplant placement will be performed without a graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years of age
- Willing and able to provide informed consent
- In need of one implant to replace a missing tooth
- At least 20 teeth in good repair and occlusion
- Sufficient bone volume for dental implant placement without required bone augmentation
Key exclusion criteria (13 listed)
- Current smoker
- Implant cannot be placed without bone graft
- Unable to pay for crown
- Untreated rampant caries and/or uncontrolled periodontitis
- Absence of adjacent (mesial and/or distal) natural tooth
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 |
|---|---|---|
| Allograft mucosal enhancement with dental implantimplant placement with allograft mucosal enhancement | Device | Implant with prophylactic allograft |
| No allograft mucosal enhancement at time of dental implant placementimplant placement without allograft mucosal enhancement | Device | Implant without prophylactic allograft |
Primary outcome
Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning
Time frame: 12 months post implant surgery
Volume of the alveolar ridge (percentage change of the volume) as measured by 3D Intraoral scanning
3 secondary outcomes
Percentage of Implant Survival
Time frame: 12 months post implant surgery
Marginal Bone Levels (MBLs)
Time frame: 12 months post implant surgery
Vertical Tissue Change as Measured by 3D Intraoral Scanning
Time frame: 12 months post surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Recruiting
Clinical Efficacy of Nobel Parallel CC Implants With on1 Abutment in Posterior Area Participants
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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.
Sandra Al-Tarawneh principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Allograft mucosal enhancement with dental implant and No allograft mucosal enhancement at time of dental implant placement in people with Dental Implant Failure Nos, run by University of Illinois Chicago at 1 site 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 6 inclusion and 13 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 28 Feb 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Feb 2025). 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?
Percent Change in Volume of Alveolar Ridge as Measured by 3D Intraoral Scanning (time frame: 12 months post implant surgery). 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 28 Feb 2025.