Ridge PreservationTADNCT03205800
Temporary Anchorage Devices for Ridge Preservation
A study testing Mini-screw in people with Ridge Preservation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation
- What is being tested?
- Mini-screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jan 2018to 9 Nov 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- two maxillary premolars (left and right) required to be extracted based on recommended dental treatment plans
Who cannot join
- uncontrolled hypertension
- diabetes mellitus
- subjects with a history of a long-term use of corticosteroid (> 6 months)
- subjects with a history of taking oral/IV bisphosphonates within the past 2 years
- smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland School of Dentistry
Baltimore, Maryland, 21201
About this study
Official title: The Use of Temporary Anchorage Devices for Ridge Preservation After Tooth Extraction
Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a tooth). Therefore, we would like to place small screws at the extraction sites to preserve the alveolar bone when the teeth need to be extracted and a patient cannot start treatments some time.
Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We will recruit patients who require extractions of two upper small molars (maxillary premolars) on both right and left sides. We will place one mini-screw on one side while the other side will be untouched after teeth extractions. Both sides will be followed at 8 months for examinations.
Read the detailed description
The purpose of this study is to investigate the effects of transcortical mini-screws on ridge preservation following tooth extraction with a split mouth design. The study will evaluate clinical and radiographic outcomes following transcortical screw placements at extraction sites compared to non-treated extraction sites.
Specific Aim 1: To evaluate the clinical outcomes between the treated sites with a transcortical screw (the experimental group) and the non-treated sites (the control group) Null Hypothesis: There will be no differences in clinical parameters between the two groups.
Approach: The investigators will conduct a prospective split-mouth design clinical study. The investigators will compare the clinical changes in vertical bone height and horizontal bone width at 8 months from baseline (tooth extraction).
Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Null Hypothesis: There will be no difference in alveolar ridge height and width between the two groups.
Approach: The study will measure ridge height and width using cone beam computed tomography (CBCT) at baseline and 8 months.
- Conditions
- Ridge Preservation
- Being tested
- Mini-screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-screwDevice
Placement of a mini-screw
| Study group | Role | What they receive |
|---|---|---|
| Mini-screw placement | Experimental | One mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side. Receives: Device: Mini-screw |
| No treatment | No intervention | No treatment will be conducted on the contralateral side. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Width of Extraction Site (Ridge)
the distance from the buccal plate to the palatal plate
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start12 Jan 2018
- Primary completion9 Nov 2020
- Study completion9 Nov 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ridge PreservationStudies 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
- a split-mouth design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 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, Study chair, University of Maryland School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205800
- Sponsor's protocol ID
- HP-00076020
- Acronym
- TAD
- Status last verified
- Jan 2025
- First submitted
- 29 Jun 2017
- Last updated
- 19 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual patient data will not be shared. The results will be published.
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 34741321
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Temporary Anchorage Devices for Ridge Preservation After Tooth Extraction
- ClinicalTrials.gov ID
- NCT03205800
- Acronym / sponsor ID
- TAD / HP-00076020
- Conditions
- Ridge Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 12 Jan 2018 (actual)
- Primary completion
- 9 Nov 2020 (actual)
- Study completion
- 9 Nov 2020 (actual)
- First posted
- 2 Jul 2017 (actual)
- Results
- Posted 19 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Alveolar bone is a bony portion surrounding the root of a tooth. The alveolar bone disappears gradually when the tooth is extracted. This bone loss often becomes a problem if a patient wants to close the missing tooth space with orthodontic treatments (braces), or to get a dental implant (a metal post replacing a tooth). Therefore, we would like to place small screws at the extraction sites to preserve the alveolar bone when the teeth need to be extracted and a patient cannot start treatments some time.
Mini-screws (small metal screws) are routinely used for regular orthodontic treatment. We will recruit patients who require extractions of two upper small molars (maxillary premolars) on both right and left sides. We will place one mini-screw on one side while the other side will be untouched after teeth extractions. Both sides will be followed at 8 months for examinations.
Detailed description
The purpose of this study is to investigate the effects of transcortical mini-screws on ridge preservation following tooth extraction with a split mouth design. The study will evaluate clinical and radiographic outcomes following transcortical screw placements at extraction sites compared to non-treated extraction sites.
Specific Aim 1: To evaluate the clinical outcomes between the treated sites with a transcortical screw (the experimental group) and the non-treated sites (the control group) Null Hypothesis: There will be no differences in clinical parameters between the two groups.
Approach: The investigators will conduct a prospective split-mouth design clinical study. The investigators will compare the clinical changes in vertical bone height and horizontal bone width at 8 months from baseline (tooth extraction).
Specific Aim 2: To evaluate the radiographic outcome between the experimental group and the control group Null Hypothesis: There will be no difference in alveolar ridge height and width between the two groups.
Approach: The study will measure ridge height and width using cone beam computed tomography (CBCT) at baseline and 8 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- a split-mouth design
| Arm | Type | Receives |
|---|---|---|
| Mini-screw placement | Experimental | Device: Mini-screwOne mini-screw (8 mm length) will be placed at the buccal plate of the extraction socket one week after the atraumatic extraction of maxillary first or second premolars in one side. |
| No treatment | No intervention | –No treatment will be conducted on the contralateral side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥ 18 years
- two maxillary premolars (left and right) required to be extracted based on recommended dental treatment plans
Key exclusion criteria (5 listed)
- uncontrolled hypertension
- diabetes mellitus
- subjects with a history of a long-term use of corticosteroid (> 6 months)
- subjects with a history of taking oral/IV bisphosphonates within the past 2 years
- smokers
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 |
|---|---|---|
| Mini-screwPlacement of a mini-screw | Device | Mini-screw placement |
Primary outcome
Changes in Width of Extraction Site (Ridge)
Time frame: 8 months
the distance from the buccal plate to the palatal plate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: 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.
- Individual participant dataSharing planned: No. Individual patient data will not be shared. The results will be published.
Related trials for Ridge Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
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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
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Recruiting
Different Approaches for Alveolar Ridge Preservation
Alveolar Ridge Resorption
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 study chair
University of Maryland School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-screw in people with Ridge Preservation, run by University of Maryland, Baltimore 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 2 inclusion and 5 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 19 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 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?
Changes in Width of Extraction Site (Ridge) (time frame: 8 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 NCT03205800, which also lists 1 linked publication.
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 19 Feb 2025.