Tooth LossPilotXenAlloNCT04550689
Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft
A study testing Bone graft in people with Tooth Loss, run by UConn Health at 1 site in United States.
Trial summary
To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Bone graft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females ≥ 21 years of age
- Able to provide informed consent
- Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
- Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
- Presence of natural teeth adjacent to the tooth planned for extraction
- Absence of acute signs of infection such as pus discharge, fistulous tract and / or abscess in relation to tooth being extracted
- Dehiscence type defects of the sockets limited to 2/3rd length of the root
Who cannot join
- Systemic conditions
- Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
- Conditions requiring chronic routine use of antibiotics or steroids
- History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
- Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
- Simultaneous participation in other studies
Show all 15Show fewer
- Pregnancy - Patients pregnant before the start of the study or patients who become pregnant during the course of the study
- Local conditions
- Untreated periodontitis, caries or presence of hopeless teeth (other than the one planned for extraction)
- Multi rooted teeth
- Irradiation therapy
- Osseous lesions
- Missing teeth adjacent to the tooth being extracted
- Implant restorations adjacent to the tooth being extracted
- Multiple socket walls missing following extraction or buccal dehiscence defect extending to the apex of the root
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft
To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
Read the detailed description
AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
PRIMARY OBJECTIVE
Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.
SECONDARY OBJECTIVE
- Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.
Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.
NULL HYPOTHESIS
There is no difference between the two groups for any of the parameters evaluated.
- Conditions
- Tooth Loss
- Being tested
- Bone graft
- Keywords
- dental, socket grafting, bone graft, alveolar, xenograft, allograft, implant, ridge preservation, CBCT
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone graftDevice
Bone grafts produced by Straumann LLC
| Study group | Role | What they receive |
|---|---|---|
| Xenograft | Active comparator | Not described Receives: Device: Bone graft |
| Allograft | Active comparator | Not described Receives: Device: Bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction
Measured: 6 months
Secondary outcomes (3)
Horizontal dimensional changes measured intra-operatively using a Periodontal Probe
Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Measurements will be made using a periodontal probe from the Mid-buccal to the mid-palatal/mid-lingual aspect of the ridge using a surgical stent
Measured: 6 months
Vertical dimensional changes measured intra-operatively using a periodontal probe and stent
Dimensional changes of the crest measured intra-operatively immediately post extraction and grafting and compared to 6 months post extraction. Vertical measurements will be made using a periodontal probe and a patient specific stent. The probe will help measure changes in height of buccal and palatal / lingual plate at the center of the ridge.
Measured: 6 months
Histologic analysis of bone biopsy cores
Histologic analysis of the bone biopsy cores taken from the xenograft or allograft grafted extraction sockets
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Oct 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth LossStudies 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
- Model description
- Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Sejal Thacker, UConn Health
- Investigators
- Sejal Thacker, D.D.S., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04550689
- Sponsor's protocol ID
- 20-137-1
- Other IDs
- 601907
- Acronym
- PilotXenAllo
- Status last verified
- Nov 2023
- First submitted
- 7 Sep 2020
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft
- ClinicalTrials.gov ID
- NCT04550689
- Acronym / sponsor ID
- PilotXenAllo / 20-137-1
- Conditions
- Tooth Loss
- Keywords
- dental, socket grafting, bone graft, alveolar, xenograft, allograft, implant, ridge preservation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 16 Sep 2020 (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.
To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
Detailed description
AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.
PRIMARY OBJECTIVE
Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft.
SECONDARY OBJECTIVE
- Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction.
- Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site.
Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT.
NULL HYPOTHESIS
There is no difference between the two groups for any of the parameters evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel arm with subjects randomly receiving allograft or xenograft for ridge preservation
| Arm | Type | Receives |
|---|---|---|
| Xenograft | Active comparator | Device: Bone graft |
| Allograft | Active comparator | Device: Bone graft |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females ≥ 21 years of age
- Able to provide informed consent
- Good general oral health (no active periodontal disease, absence of hopeless teeth, absence of active caries, absence of acute infections)
- Single rooted non molar teeth needing extraction for miscellaneous reasons (since histological analysis is being done, it is essential to harvest bone core biopsies without inclusion of native bone16)
- Presence of natural teeth adjacent to the tooth planned for extraction
Key exclusion criteria (15 listed)
- Systemic conditions
- Conditions and circumstances as evaluated by investigator that would prevent completion of study participation
- Conditions requiring chronic routine use of antibiotics or steroids
- History of leukocyte dysfunction or deficiencies, bleeding disorders, neoplastic disease requiring radiation or chemotherapy, metabolic bone disorder, uncontrolled endocrine disorders, HIV infections
- Alcoholism or drug abuse and heavy smokers >10 cigarettes a day
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 |
|---|---|---|
| Bone graftBone grafts produced by Straumann LLC | Device | Allograft, Xenograft |
Primary outcome
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography
Time frame: 6 months
Dimensional changes measured from a Cone Beam Computed Tomography immediately post extraction and grafting and 6 months post extraction
3 secondary outcomes
Horizontal dimensional changes measured intra-operatively using a Periodontal Probe
Time frame: 6 months
Vertical dimensional changes measured intra-operatively using a periodontal probe and stent
Time frame: 6 months
Histologic analysis of bone biopsy cores
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Sejal Thacker, D.D.S. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone graft in people with Tooth Loss, run by UConn Health 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 7 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: under way, not looking for participants, as of the sponsor's last update on 28 Nov 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Horizontal and vertical dimensional changes noted on Cone Beam Computed Tomography (time frame: 6 months). 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 Nov 2023.