Wound HealNCT06261762
Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone
An observational study of Wound Heal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
Trial summary
The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Wound Heal
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 29 Feb 2024to 30 Jun 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for consecutive (two) teeth extraction in the anterior maxilla.
Who may be able to join
- 18+ years old
- Require consecutive (two) teeth replacement in the anterior maxilla
- Signed informed consent
- No significant medical conditions
- Patients with healthy periodontal conditions or previously treated to controlled and stable conditions
Who cannot join
- General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
- Pregnancy or nursing
- Any interfering medication such as steroid therapy or bisphosphonate therapy
- Uncontrolled diabetes
- Autoimmune diseases or inflammatory diseases affecting the intraoral tissues
- Radiation therapy to head or neck region
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone: A Pilot Study
The goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:
- Is significant alveolar ridge resorption observed at center sites after consecutive extractions
- Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
- Is a thick or thin wall phenotype associated with the amount of bone resorption
- Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
- Is the interdental papilla height significantly affected after extractions.
Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks.
- Conditions
- Wound Heal
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone level change from baseline
Measured in millimeters using segmented surface model superimpositions. Changes in bone loss between baseline and an 8 week healing period using CBCT. From the Digital Imaging and Communications in Medicine (DICOM) files two surface mesh models were generated, which were superimposed and the changes were subsequently analyzed.
Measured: Baseline and at 8 weeks
Soft tissue change from baseline
Changes in soft tissue loss at baseline and 8 weeks were analyzed using digital dental impressions acquired from intraoral scans, which were superimposed and the changes were analyzed.
Measured: Baseline and at 8 weeks
Secondary outcomes (1)
Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum.
To measure correlation, the Spearman Rank Correlation Coefficient was calculated. Nonparametric models for longitudinal data were applied to analyze the impact of bone wall phenotype and healing period upon dimensional alterations.
Measured: Baseline and at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start29 Feb 2024 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Feng Wang, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261762
- Sponsor's protocol ID
- SDC-24-1
- Status last verified
- Feb 2024
- First submitted
- 7 Feb 2024
- Last updated
- 15 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone: A Pilot Study
- ClinicalTrials.gov ID
- NCT06261762
- Acronym / sponsor ID
- SDC-24-1
- Conditions
- Wound Heal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Feb 2024 (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 goal of this observational study is to evaluate the post-extraction hard and soft tissue dimension changes in patients requiring consecutive extractions and unassisted socket healing in the anterior maxilla. The main questions it aims to answer are:
- Is significant alveolar ridge resorption observed at center sites after consecutive extractions
- Is significant alveolar ridge resorption observed at the interalveolar septum after consecutive extractions, are different extraction sites associated with significantly different bone resorption
- Is a thick or thin wall phenotype associated with the amount of bone resorption
- Is soft tissue thickness change associated with the corresponding location (extraction site or interalveolar septum) and post-extraction thickness of the bone
- Is the interdental papilla height significantly affected after extractions.
Participants will undergo consecutive (two) extractions and will be evaluated after subsequent unassisted socket healing for 8 weeks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The group is selected from the referred patient pool. Age 18 or older. Absence of significant medical conditions. Sites with a need for consecutive (two) teeth extraction in the anterior maxilla.
Key inclusion criteria (5 listed)
- 18+ years old
- Require consecutive (two) teeth replacement in the anterior maxilla
- Signed informed consent
- No significant medical conditions
- Patients with healthy periodontal conditions or previously treated to controlled and stable conditions
Key exclusion criteria (6 listed)
- General medical (American Society of Anesthesiologists, ASA, class III or IV) and/or psychiatric contraindications
- Pregnancy or nursing
- Any interfering medication such as steroid therapy or bisphosphonate therapy
- Uncontrolled diabetes
- Autoimmune diseases or inflammatory diseases affecting the intraoral tissues
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bone level change from baseline
Time frame: Baseline and at 8 weeks
Measured in millimeters using segmented surface model superimpositions. Changes in bone loss between baseline and an 8 week healing period using CBCT. From the Digital Imaging and Communications in Medicine (DICOM) files two surface mesh models were generated, which were superimposed and the changes were subsequently analyzed.
Soft tissue change from baseline
Time frame: Baseline and at 8 weeks
Changes in soft tissue loss at baseline and 8 weeks were analyzed using digital dental impressions acquired from intraoral scans, which were superimposed and the changes were analyzed.
1 secondary outcome
Correlation between baseline facial bone thickness and dimensional soft tissue alterations during healing at the interalveolar septum.
Time frame: Baseline and at 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
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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.
Feng Wang principal investigator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University.
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 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinbo Yu (18019409340, xinboyu@proton.me), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone level change from baseline (time frame: Baseline and at 8 weeks). The study lists 2 primary outcomes in all. 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 15 Feb 2024.