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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Wound Heal

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Xinbo Yu; Phone Number: 18019409340; Email: xinboyu@proton.me

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and at 8 weeks

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Investigators: Principal Investigator: Feng Wang, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Estimated): February 29, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: February 7, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Estimated): February 15, 2024

Study Record Updates

• Last Update Posted (Estimated): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SDC-24-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No