NCT06261762

Unknown

Hard and Soft Tissue Dimensional Change After Consecutive Ex...

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

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Other study identifiers

Sponsor study identifier

SDC-24-1

Study Type

observational

Estimated enrollment

20

Locations

0 countries

Sites

N/A

Timeline

Study Start

February 29, 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: unknown
Estimated enrollment: 20 participants
Study completion date: June 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
February 7, 2024
Actual (reported)
First Posted
February 15, 2024
Actual (reported)
Study Start
February 29, 2024
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2026
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: February 15, 2024
Status Verified: February 2024
Last Update Submitted: February 7, 2024

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

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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

Sponsors & Collaborators

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

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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

June 30, 2026

Estimated (date passed)

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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

Contact the study team to confirm eligibility.

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Study Completion

June 30, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

February 15, 2024

Record last verified: 2024-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

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Registry identifier: NCT06261762
Data provider: ClinicalTrials.gov
Source updated: 2024-02-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:39:13 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record