Tooth ExtractionNCT02844569

A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction

A study testing Xenograft bone substitute, Collagen dressing and 3D-collagen matrix in people with Tooth Extraction, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Extraction
What is being tested?: Xenograft bone substitute, Collagen dressing and 3D-collagen matrix
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Jul 2016to 28 Feb 2018
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 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects must be adult males or females age 18 to 80 years (inclusive).
Subjects must be able and willing to follow study procedures and instructions in English.
Subjects must have read, understood and signed an informed consent form in English.
Subjects must have a maxillary premolar, canine, lateral incisor, or central incisor with a restorative or periodontal hopeless prognosis (Kwok and Caton 2007), in which an implant is indicated without any sinus lift required.
Subjects undergoing implant placement should be in adequate periodontal health prior to implant placement. This includes having probing depth ≤ 4 mm for all remaining teeth at the same quadrant of the proposed implant placement. Patients with periodontal probing sites with probing depths of up to 5 mm may also be included if bleeding on probing in these sites is absent. Each subject should be considered to be periodontally stable prior to the implant surgery.

Who cannot join

Individuals who have a chronic disease with oral manifestations.
Individuals who exhibit gross oral pathology.
The use of either antibiotics or chronic use (more than 7 days) of NSAIDs within 1 month prior to screening examination.
Individuals that require antibiotic prophylaxis prior to dental treatment.
Chronic treatment (i.e. two weeks or more) with any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin) within 1 month prior to screening examination.
Uncontrolled diabetes mellitus (HbA1c >7) within 3 months prior to screening examination.

Show all 16Show fewer

Individual with uncontrolled parafunctional habits, such as clenching and bruxing on objects, that could adversely impact implant survival.
Individuals with a history of intravenous bisphosphonates.
Individuals with active infectious diseases such as hepatitis, HIV or tuberculosis.
Current cigarette smokers.
Individuals who are known to be pregnant, breastfeeding or planning to become pregnant within 6 months.
Individuals with blood disorders (hemophilia) and /or currently taking anticoagulant medications, such as heparin, warfarin, or clopidogrel.
Individuals receiving any therapy known to affect healing, such as high dose corticosteroids, radiation therapy or chemotherapy.
Individuals allergic to topical or local anesthesia.
Individuals who require maxillary sinus augmentation prior to dental implant therapy.
Individuals with dehisced, fenestrated, or fractured labial/buccal alveolar bone plate determined after baseline CBCT or after tooth extraction where more than 50% of the buccal bone height is not present. In this case, if the surgeon determines that guided bone regeneration (bone graft and membrane) is needed to repair the defect, it will be done at no cost to the subject, but the subject will be excluded from the study protocol.

Trial locations and contacts

1 site in 1 country.

United States1 site

General & Oral Health Center
Chapel Hill, North Carolina, 27599-7450

Other trials in United States

About this study

This study will be a randomized clinical trial involving a total of 24 subjects. The investigators propose to recruit subjects into 2 groups: 1) Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®), 2) Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). All subjects recruited will have already been approved and treatment planned for extraction + implant placement by non-study personnel to avoid any potential conflict of interest. All subjects will have radiographs that show the tooth planned for extraction. Each subject will be eligible for only 1 tooth extraction + dental implant rehabilitation. After tooth extraction, subjects will receive a standard site preservation therapy consisted with xenograft bone substitute + collagen dressing or the alternative site preservation therapy consisted with xenograft bone substitute + 3D-collagen matrix. After the conventional 6-month healing period, subjects will receive a dental implant in the previous extracted site. During the dental implant procedure, a 2x5mm bone core biopsy + a 2mm gingival biopsy will be obtained from the implant site. Biopsy samples will be stored for future histological and histochemical analysis. After dental implant placement, all subjects will receive a healing abutment for soft tissue healing prior to implant restoration.

During the 6-month healing time after tooth extraction and site preservation therapy, subjects will return at week-1, week-2, week-4, month-3, and month-6 for intra-oral scanning for soft tissue volumetric acquirement. Subjects will receive a Cone beam computed tomography (CBCT) prior to extraction for the baseline hard-tissue volume measurement and appropriate extraction planning and at 6-month post-extraction for volumetric measurement and appropriate implant treatment planning.

Hard tissue analysis will be performed to compare linear ridge remodeling (baseline vs. 6-month healing). CBCT images will be analyzed by non-contact reverse engineering system. Soft tissue volumetric analysis will be performed to compare the soft tissue healing between BioOss Collagen + Mucograft Seal and BioOss Collagen + Collagen Dressing. Images captured with an intra-oral scanner collected at baseline, week-1, -2, -4, month-3, and month-6.

Conditions: Tooth Extraction
Being tested: Xenograft bone substitute, Collagen dressing, 3D-collagen matrix
Keywords: Dental Implants, Bone Grafting

What participants receive

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

Xenograft bone substituteDevice
Also called BioOss Collagen®
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
Collagen dressingDevice
Also called HeliPlug®
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
3D-collagen matrixDevice
Also called Mucograft Seal®
Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.

Study groups in NCT02844569
Study group	Role	What they receive
Test	Experimental	Extraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®). Receives: Device: Xenograft bone substitute; Device: 3D-collagen matrix
Control	Active comparator	Extraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®). Receives: Device: Xenograft bone substitute; Device: Collagen dressing

What is being measured

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

Change in Buccal Plate Thickness From Baseline to Month 6
The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.
Measured: 6 months
Change in Buccal Soft Tissue Volume Between Baseline and 6 Months
The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner.
Measured: 6 months
Change in Buccal Bone Volume Between Baseline and 6 Months
The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data.
Measured: 6 months

Timeline

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

Jul 201628 Feb 2018

First posted26 Jul 2016 (estimated)
Study startJul 2016
Primary completion28 Feb 2018
Study completion28 Feb 2018

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 Tooth ExtractionStudies of the same condition, open and under way.
More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
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: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02844569
Sponsor's protocol ID: 16-0832
Status last verified: Nov 2018
First submitted: 21 Jul 2016
Last updated: 6 Feb 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Deidentified individual data that supports the results will be shared beginning 9-36 months following publication.

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

Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction

All Tooth Extraction trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Volumetric Analysis of Soft and Hard Tissue Healing for Ridge Preservation and Socket Seal After Tooth Extraction
ClinicalTrials.gov ID: NCT02844569
Acronym / sponsor ID: 16-0832
Conditions: Tooth Extraction
Keywords: Dental Implants, Bone Grafting
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of North Carolina, Chapel HillUniversity, hospital or other
Collaborators: Geistlich Pharma AG
Study start: Jul 2016
Primary completion: 28 Feb 2018 (actual)
Study completion: 28 Feb 2018 (actual)
First posted: 26 Jul 2016 (estimated)
Results: Posted 6 Feb 2019

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: None (open label)
Number of arms: 2

Arm	Type	Receives
Test	Experimental	Device: Xenograft bone substitute, Device: 3D-collagen matrixExtraction treated with xenograft bone substitute (BioOss Collagen®) + 3D-collagen matrix (Mucograft Seal®).
Control	Active comparator	Device: Xenograft bone substitute, Device: Collagen dressingExtraction treated with xenograft bone substitute (BioOss Collagen®) + collagen dressing (HeliPlug®).

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Subjects must be adult males or females age 18 to 80 years (inclusive).
Subjects must be able and willing to follow study procedures and instructions in English.
Subjects must have read, understood and signed an informed consent form in English.
Subjects must have a maxillary premolar, canine, lateral incisor, or central incisor with a restorative or periodontal hopeless prognosis (Kwok and Caton 2007), in which an implant is indicated without any sinus lift required.
Subjects undergoing implant placement should be in adequate periodontal health prior to implant placement. This includes having probing depth ≤ 4 mm for all remaining teeth at the same quadrant of the proposed implant placement. Patients with periodontal probing sites with probing depths of up to 5 mm may also be included if bleeding on probing in these sites is absent. Each subject should be considered to be periodontally stable prior to the implant surgery.

Key exclusion criteria (16 listed)

Individuals who have a chronic disease with oral manifestations.
Individuals who exhibit gross oral pathology.
The use of either antibiotics or chronic use (more than 7 days) of NSAIDs within 1 month prior to screening examination.
Individuals that require antibiotic prophylaxis prior to dental treatment.
Chronic treatment (i.e. two weeks or more) with any medication known to affect periodontal status (e.g. phenytoin, calcium antagonists, cyclosporine, Coumadin) within 1 month prior to screening examination.

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
Xenograft bone substituteAlso: BioOss Collagen®Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.	Device	Control, Test
Collagen dressingAlso: HeliPlug®Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.	Device	Control
3D-collagen matrixAlso: Mucograft Seal®Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.	Device	Test

Primary outcome

Change in Buccal Plate Thickness From Baseline to Month 6
Time frame: 6 months
The thickness difference between baseline and 6 months will be measured by the difference in mm using cone-beam computed tomography.
Change in Buccal Soft Tissue Volume Between Baseline and 6 Months
Time frame: 6 months
The soft tissue volume change between baseline and 6 months based on 3D images captured with intra-oral digital scanner.
Change in Buccal Bone Volume Between Baseline and 6 Months
Time frame: 6 months
The buccal bone volume change between baseline and 6 months will be calculated from cone-beam computed tomography data.

Results and safety

Results posted to the registry on 6 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test	12	12
Control	12	12

Primary outcome: Change in Buccal Plate Thickness From Baseline to Month 6

Time frame: 6 months. Mean (Standard Deviation). Unit: mm

Measure	Test n = 10	Control n = 8
Value	1.85 (0.72)	1.25 (0.45)

Test vs Control: p = 0.11, t-test, 2 sided

Primary outcome: Change in Buccal Soft Tissue Volume Between Baseline and 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: mm^3

Measure	Test n = 12	Control n = 12
Value	68.6 (25.4)	87.6 (39.1)

Test vs Control: p <0.01, Mixed Models Analysis

Primary outcome: Change in Buccal Bone Volume Between Baseline and 6 Months

Time frame: 6 months. Mean (Standard Deviation). Unit: mm^3

Measure	Test n = 12	Control n = 12
Value	72.6 (30.7)	60.9 (37.3)

Test vs Control: p = 0.66, t-test, 2 sided

Adverse events

Time frame: From time of extraction through 7 months after extraction. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 12 (0%)	0 of 12 (0%)	0 of 12
Control	0 of 12 (0%)	0 of 12 (0%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9-36 months following publication.

Related trials for Tooth Extraction

Not yet recruitingPhase 2
Melatonin in Posterior Mandible Extraction Socket
Bone Loss
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
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
Recruiting
Assessment of the Locally Administrated Vitamin D3 and Corticision Efficacy on Orthodontic Canine Retraction
Malocclusions, Canine Retraction

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.

Julie Marchesan, DDS, PhD principal investigator

Assistant Professor Periodontology

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

Questions about this trial

What is this clinical trial studying?

A study testing Xenograft bone substitute, Collagen dressing and 3D-collagen matrix in people with Tooth Extraction, run by University of North Carolina, Chapel Hill 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 5 inclusion and 16 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 6 Feb 2019. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Feb 2019). 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 Buccal Plate Thickness From Baseline to Month 6 (time frame: 6 months). 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?

On the ClinicalTrials.gov record for NCT02844569.

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 6 Feb 2019.