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

Wound Heal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06261762
• Other study ID #: SDC-24-1
• Status: Not yet recruiting
• Start date: February 29, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
• Contact: Xinbo Yu
• Phone: 18019409340
• Email: xinboyu[@]proton.me
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Wound Heal

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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