Hard and Soft Tissue Dimensional Change After Consecutive Extractions and Unassisted Socket Healing in the Esthetic Zone

NCT06261762 | Not Yet Recruiting

• 1 other identifier: SDC-24-1
• Study Type: observational
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  Baseline and at 8 weeks

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Officials

• Feng Wang

  Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinbo Yu

CONTACT

18019409340; xinboyu@proton.me

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2024
• First Posted: February 15, 2024
• Study Start: February 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 15, 2024

Record last verified: 2024-02