NCT06510621

Brief Summary

Background This study was conducted to investigate the clinical efficacy of Socket-Shield Technique on the first premolar bone preservation in Orthodontic Extraction Treatment. Methods patients were underwent Orthodontic Extraction Treatment in the First Affiliated Hospital of Guangzhou Medical University were enrolled. Extracted teeth were paired and randomly allocated into two groups: test group (Socket-Shield Technique) and control group. Cone beam computerized tomography were utilized to access the horizontal resorption and vertical resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest, as well as tooth movement rate at four time-points: before tooth extraction (T0), three months after tooth extraction (T1), the juncture socket-shield was removed (T2) and three months after socket-shield removal (T3).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

November 13, 2024

Status Verified

November 1, 2024

Enrollment Period

8 months

First QC Date

July 8, 2024

Last Update Submit

November 9, 2024

Conditions

Keywords

Socket-Shield TechniqueBone preservationFirst premolar extractionOrthodontics

Outcome Measures

Primary Outcomes (2)

  • Vertical alveolar bone loss

    Cone beam computerized tomography were utilized to access the vertical resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest

    0 weeks, 3 months, 6 months and 9 months

  • Horizontal alveolar bone loss

    Cone beam computerized tomography were utilized to access the horizontal resorption at 1mm, 3mm and 5mm from a reference plane of alveolar crest

    0 weeks, 3 months, 6 months and 9 months

Secondary Outcomes (1)

  • Tooth movement rate

    3 months, 6 months and 9 months

Study Arms (2)

Socket-Shield Technique

EXPERIMENTAL

Cut the tooth crown; divided along the long axis; trim the socket shield. Finally, the socket-shield was removed by minimally invasive forceps when the adjacent tooth moved proximate to the shield during the process of closing orthodontic gap.

Procedure: Socket-Shield Technique

non-Socket-Shield Technique

NO INTERVENTION

A high-speed turbine was used to cut the tooth crown 1.5-2 mm from the buccal gingival margin. The tooth was then divided along the long axis, approximately 2 mm from the buccal side. The palatal roots were removed using minimally invasive elevation and extraction forceps. Next, the buccal socket-shield was trimmed to approximately 4-6 mm in height (1 mm from the buccal gingival margin), 3-4 mm in width, and 1-1.5 mm in thickness. The trimming process required with clear visualization of the shield and calibration by periodontal probe. Finally, the socket-shield was removed immediately

Interventions

A high-speed turbine was used to cut the tooth crown 1.5-2 mm from the buccal gingival margin. The tooth was then divided along the long axis, approximately 2 mm from the buccal side(Figure 1c, 1d). The palatal roots were removed using minimally invasive elevation and extraction forceps. Next, the buccal socket-shield was trimmed to approximately 4-6 mm in height (1 mm from the buccal gingival margin)\[18\], 3-4 mm in width, and 1-1.5 mm in thickness\[19,20\]. The trimming process required with clear visualization of the shield and calibration by periodontal probe. Finally, the socket-shield was removed by minimally invasive forceps when the adjacent tooth moved proximate to the shield during the process of closing orthodontic gap.

Socket-Shield Technique

Eligibility Criteria

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

You may qualify if:

  • had an orthodontic treatment plan involving the extraction of symmetrical left and right first premolars;
  • had maxillary protrusion or bimaxillary protrusion with crowding within 4mm;
  • had permanent dentition;
  • had good oral hygiene and had no periodontitis;
  • agreed to the orthodontic extraction treatment plan and signed the treatment informed consent form and the experimental informed consent form.

You may not qualify if:

  • underlying diseases such as hypertension, heart disease, diabetes, osteoporosis, or hyperthyroidism;
  • infection in the extraction area;
  • dental root caries in the extraction area;
  • gingival recession on the buccal aspect of the extraction area;
  • refused to undergo SST treatments;
  • pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

  • Zhang Y, Ji Z, Lin L, Ye H, Ji J. The socket-shield technique in orthodontics: a method for alveolar ridge preservation. Oral Maxillofac Surg. 2026 Jan 10;30(1):16. doi: 10.1007/s10006-025-01501-9.

MeSH Terms

Interventions

Immediate Dental Implant Loading

Intervention Hierarchy (Ancestors)

Dental Implantation, EndosseousDental ImplantationOral Surgical Procedures, PreprostheticOral Surgical ProceduresSurgical Procedures, OperativeProsthesis ImplantationDentistryProsthodontics

Study Officials

  • Jianxin Ji, DDS

    The First Affiliated Hospital of Guangzhou Medical University

    STUDY CHAIR
  • Yuhang Zhang, MS

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR
  • Zhe Ji, MS

    The First Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Department of Stomatology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

July 8, 2024

First Posted

July 19, 2024

Study Start

January 2, 2024

Primary Completion

September 2, 2024

Study Completion

October 1, 2024

Last Updated

November 13, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations