Healing WoundNCT05297071
Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography
A study testing Orascopic HDL 3.0 Loupes and Semorr DOM3000D Operation Microscope in people with Healing Wound, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Healing Wound
- What is being tested?
- Orascopic HDL 3.0 Loupes and Semorr DOM3000D Operation Microscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2022to 21 Jul 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Single maxillary or mandibular hopeless tooth (a maxillary or mandibular anterior tooth or premolar) planned for extraction due to periapical pathology with a minimum ≥2 mm of the size of the periapical radiolucency shown on a peri-apical film.
- The patient is planned for implant restoration for the hopeless tooth
- The study site allows for implant placement with or without additional bone augmentation procedures after the healing
- Adequate edentulous space for the final restoration on the implant
Who cannot join
- Current smokers or quit smoking less than 6 months
- Major or uncontrolled medical conditions, e.g. poorly controlled diabetes mellitus (HbA1c >8.0%, uncontrolled systemic disease or condition known to alter bone metabolism, e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, etc.
- Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported)
- Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography - A Randomized Controlled Trial
The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). These devices magnify and shine light on the area where the surgeon operates.
Read the detailed description
After a tooth is extracted, a hole is left in the bone called a socket. During the first year of healing after a tooth extraction, there may be up to 60% loss of bone volume at the site. Loss of bone at the edentulous ridge (toothless area) may make it more difficult to place dental implants later. Dental socket grafting is performed to reduce bone resorption after tooth extraction. Grafting involves filling the socket with bone graft (donated human cadaver derived) and covering it with a protective collagen membrane. This graft prevents resorption of the ridge and is slowly replaced with the patient's own bone. The investigators will be trying to determine if bone healing is better if the surgeon uses more powerful magnification.
- Conditions
- Healing Wound
- Being tested
- Orascopic HDL 3.0 Loupes, Semorr DOM3000D Operation Microscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orascopic HDL 3.0 LoupesDevice
The loupes will be used during the surgical procedure on half of the subjects. The other half will be performed with a microscope.
Semorr DOM3000D Operation MicroscopeDevice
The microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes.
| Study group | Role | What they receive |
|---|---|---|
| Dental Loupes | Other | The surgeon will use dental loupes with a head lamp during the subject's tooth extraction and socket grafting. Receives: Device: Orascopic HDL 3.0 Loupes |
| Surgical microscope | Other | The surgeon will use a surgical microscope (with built-in lighting) during the subject's tooth extraction and socket grafting. Receives: Device: Semorr DOM3000D Operation Microscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone quality
Difference in bone density from the CBCT and ultrasound
Measured: 12 weeks
Secondary outcomes (1)
Patient-reported outcomes
Difference in patient-reported outcomes. Subjects will be given a questionnaire to evaluate pain perception, pain medication use, and complications after surgery.
Measured: 1 week, 2 weeks, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start22 Mar 2022
- Primary completion26 Jun 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Delta Dental Foundation
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
- Investigators
- Hsun-Liang Chan, DDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05297071
- Sponsor's protocol ID
- HUM00195615
- Status last verified
- Feb 2024
- First submitted
- 16 Mar 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Microsurgical Socket Augmentation Healing With Ultrasonography - A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05297071
- Acronym / sponsor ID
- HUM00195615
- Conditions
- Healing Wound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Delta Dental Foundation
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 25 Mar 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.
The purpose of this study is to assess healing after tooth extraction with simultaneous socket augmentation (bone grafting during the same appointment as the extraction) when the surgeon uses a surgical microscope, compared to when the surgeon uses dental loupes (magnifiers that are mounted on the surgeon's glasses). These devices magnify and shine light on the area where the surgeon operates.
Detailed description
After a tooth is extracted, a hole is left in the bone called a socket. During the first year of healing after a tooth extraction, there may be up to 60% loss of bone volume at the site. Loss of bone at the edentulous ridge (toothless area) may make it more difficult to place dental implants later. Dental socket grafting is performed to reduce bone resorption after tooth extraction. Grafting involves filling the socket with bone graft (donated human cadaver derived) and covering it with a protective collagen membrane. This graft prevents resorption of the ridge and is slowly replaced with the patient's own bone. The investigators will be trying to determine if bone healing is better if the surgeon uses more powerful magnification.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental Loupes | Other | Device: Orascopic HDL 3.0 LoupesThe surgeon will use dental loupes with a head lamp during the subject's tooth extraction and socket grafting. |
| Surgical microscope | Other | Device: Semorr DOM3000D Operation MicroscopeThe surgeon will use a surgical microscope (with built-in lighting) during the subject's tooth extraction and socket grafting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years of age
- Single maxillary or mandibular hopeless tooth (a maxillary or mandibular anterior tooth or premolar) planned for extraction due to periapical pathology with a minimum ≥2 mm of the size of the periapical radiolucency shown on a peri-apical film.
- The patient is planned for implant restoration for the hopeless tooth
- The study site allows for implant placement with or without additional bone augmentation procedures after the healing
- Adequate edentulous space for the final restoration on the implant
Key exclusion criteria (4 listed)
- Current smokers or quit smoking less than 6 months
- Major or uncontrolled medical conditions, e.g. poorly controlled diabetes mellitus (HbA1c >8.0%, uncontrolled systemic disease or condition known to alter bone metabolism, e.g. osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, etc.
- Pregnancy, breast-feeding, could be pregnant or planning to become pregnant in the next 4 months (self-reported)
- Taking medications known to modify bone metabolism (i.e. bisphosphonates, corticosteroids, hormone replacement therapy)
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 |
|---|---|---|
| Orascopic HDL 3.0 LoupesThe loupes will be used during the surgical procedure on half of the subjects. The other half will be performed with a microscope. | Device | Dental Loupes |
| Semorr DOM3000D Operation MicroscopeThe microscope will be used during the surgical procedure on half of the subjects. The other half will be performed with loupes. | Device | Surgical microscope |
Primary outcome
Bone quality
Time frame: 12 weeks
Difference in bone density from the CBCT and ultrasound
1 secondary outcome
Patient-reported outcomes
Time frame: 1 week, 2 weeks, and 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
Related trials for Healing Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
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.
Hsun-Liang Chan, DDS, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orascopic HDL 3.0 Loupes and Semorr DOM3000D Operation Microscope in people with Healing Wound, run by University of Michigan 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 4 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 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bone quality (time frame: 12 weeks). 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 2024.