Alveolar Bone ResorptionNCT05485194
Ridge Preservation Following Tooth Extraction
A study testing Reducing dimensional changes following tooth extraction in people with Alveolar Bone Resorption and Tooth Extraction, run by University of Maryland, Baltimore.
Trial summary
An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Tooth Extraction
- What is being tested?
- Reducing dimensional changes following tooth extraction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Mar 2028
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥18 years
- a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
- a tooth requiring extraction
Who cannot join
- thyroid dysfunctions
- diabetes mellitus
- history of a chronic use of corticosteroids (>6 months)
- history of oral/intravenous bisphosphonates within the past 2 years
- smoking
- history of other systemic conditions that could affect bone integrity.
About this study
Official title: Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.
Read the detailed description
The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.
- Conditions
- Alveolar Bone Resorption, Tooth Extraction
- Being tested
- Reducing dimensional changes following tooth extraction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing dimensional changes following tooth extractionOther
Use of a titanium bone screw for ridge preservation following tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Unassisted healing | No intervention | The extraction sockets in the non-intervention group will be filled with blood clots only. |
| Titanium bone screw (TBS) | Experimental | One titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Receives: Other: Reducing dimensional changes following tooth extraction |
| Alveolar ridge preservation (ARP) | Active comparator | The extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture. Receives: Other: Reducing dimensional changes following tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The width of the alveolar bone
Dimensional changes in the width of the alveolar bone following tooth extraction
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Dec 2025 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Why it stopped: No funding was obtained. Therefore, the study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Se-Lim Oh, University of Maryland, Baltimore
- Investigators
- Se-Lim Oh, Principal investigator, University of Maryland School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485194
- Sponsor's protocol ID
- HP-00102697
- Status last verified
- Jan 2025
- First submitted
- 31 Jul 2022
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shares with other researchers.
Publications
Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16.
PubMed 34741321Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18.
PubMed 25403977
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Titanium Bone Screw for Ridge Preservation Following Tooth Extraction
- ClinicalTrials.gov ID
- NCT05485194
- Acronym / sponsor ID
- HP-00102697
- Conditions
- Alveolar Bone Resorption, Tooth Extraction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding was obtained. Therefore, the study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 3 Aug 2022 (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.
An animal study and our pilot human study demonstrated that placing a smooth-surface titanium bone screw (TBS) over the buccal plate of an extraction socket resulted in less dimensional changes of the alveolar ridge along with no adverse effects. The purpose of this randomized clinical trial is to investigate the effectiveness of TBS application for ridge preservation in comparison to (1) unassisted/non-interventional socket healing and (2) alveolar ridge preservation (ARP) approach using allografts and a membrane.
Detailed description
The participants will be randomized to one of the three groups: the non-intervention, titanium bone screw (TBS), and alveolar ridge preservation (ARP) groups. The sockets in the non-intervention group will be filled with blood clots only. One TBS will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. Allograft and resorbable collagen membrane will be used for the ARP group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Unassisted healing | No intervention | –The extraction sockets in the non-intervention group will be filled with blood clots only. |
| Titanium bone screw (TBS) | Experimental | Other: Reducing dimensional changes following tooth extractionOne titanium bone screw (TBS) will be placed over the labial/buccal plate of the extraction socket in the TBS group on the same day of the extraction. |
| Alveolar ridge preservation (ARP) | Active comparator | Other: Reducing dimensional changes following tooth extractionThe extraction socket will be filled with mineralized ground cortical allograft up to the level of the buccal and lingual/palatal bony plates. A resorbable membrane will be trimmed and adapted to cover the grafting material. The flaps will be secured with a monofilament suture. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years
- a tooth, which is in the area from the central incisor to the second premolar bounded by teeth (or implants) mesiodistally
- a tooth requiring extraction
Key exclusion criteria (6 listed)
- thyroid dysfunctions
- diabetes mellitus
- history of a chronic use of corticosteroids (>6 months)
- history of oral/intravenous bisphosphonates within the past 2 years
- smoking
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 |
|---|---|---|
| Reducing dimensional changes following tooth extractionUse of a titanium bone screw for ridge preservation following tooth extraction | Other | Alveolar ridge preservation (ARP), Titanium bone screw (TBS) |
Primary outcome
The width of the alveolar bone
Time frame: up to 6 months
Dimensional changes in the width of the alveolar bone following tooth extraction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Results publication: PubMed 34741321Joseph S, Oh SL, Pae EK, Joshi S. Use of transcortical miniscrews for alveolar ridge preservation following tooth extraction: A pilot study. Clin Oral Implants Res. 2022 Feb;33(2):150-157. doi: 10.1111/clr.13875. Epub 2021 Nov 16.
- Results publication: PubMed 25403977Melsen B, Huja SS, Chien HH, Dalstra M. Alveolar bone preservation subsequent to miniscrew implant placement in a canine model. Orthod Craniofac Res. 2015 May;18(2):77-85. doi: 10.1111/ocr.12058. Epub 2014 Nov 18.
- Individual participant dataSharing planned: No. Individual participant data will not be shares with other researchers.
Related trials for Alveolar Bone Resorption
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Enrolling by invitation
Investigation of the Effect of Horizontal Platelet Rich Fibrin Placed in Tooth Extraction Sockets on Bone Formation
Tooth Loss, Dental Implant Failed
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
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.
Se-Lim Oh principal investigator
University of Maryland School of Dentistry
Questions about this trial
What is this clinical trial studying?
A study testing Reducing dimensional changes following tooth extraction in people with Alveolar Bone Resorption and Tooth Extraction, run by University of Maryland, Baltimore.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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 width of the alveolar bone (time frame: up to 6 months). 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 NCT05485194, which also lists 2 linked publications.
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 24 Jan 2025.