NCT06658860

Brief Summary

This study aimed to evaluate the dimensional changes in the alveolar ridge after tooth extraction using the socket shield technique without immediate implant placement. The changes using CBCT were assessed, focusing on the preservation of the ridge for delayed implant placement. This research could help improve dental implant outcomes by preserving bone and soft tissue structures."

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 26, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.4 years

First QC Date

October 22, 2024

Last Update Submit

October 24, 2024

Conditions

Keywords

Tooth ExtractionModified Socket Shield Technique

Outcome Measures

Primary Outcomes (2)

  • Alveolar Ridge Width Changes

    This outcome measure assesses changes in the alveolar ridge width following tooth extraction using either the modified socket shield technique or conventional extraction. Measurements were obtained through CBCT imaging at baseline and 6 months post-extraction. Unit of Measure: Millimeters (mm)

    6 months post-extraction

  • Bone Plate Height Changes

    This outcome measure assesses changes in the bone plate height following tooth extraction using either the modified socket shield technique or conventional extraction. Measurements were obtained through CBCT imaging at baseline and 6 months post-extraction. Unit of Measure: Millimeters (mm)

    6 months post-extraction

Secondary Outcomes (1)

  • Primary Implant Stability

    At the time of implant placement, typically 6 months post-extraction.

Study Arms (2)

Modified Socket Shield Technique

EXPERIMENTAL

Participants in this group underwent partial tooth extraction using the modified socket shield technique to preserve the alveolar ridge for delayed implant placement. CBCT scans were used to evaluate ridge preservation over time.

Procedure: Modified Socket Shield Technique

Conventional Tooth Extraction

ACTIVE COMPARATOR

Participants in this group underwent conventional tooth extraction without the socket shield technique. The alveolar ridge was evaluated using CBCT over the same period as the experimental group for comparison.

Procedure: Conventional Tooth Extraction

Interventions

The modified socket shield technique involves partial retention of the buccal aspect of the tooth root during extraction to preserve the surrounding alveolar bone and soft tissue. This technique is used to optimize the condition for delayed implant placement by preventing resorption of the alveolar ridge.

Modified Socket Shield Technique

Conventional tooth extraction involves the complete removal of the tooth without the use of the socket shield technique. This arm served as the control group, with alveolar ridge changes observed and compared with those in the experimental arm over time.

Conventional Tooth Extraction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non-restorable teeth in the esthetic region.
  • The buccal periodontal tissues were intact.
  • Maintaining oral hygiene.

You may not qualify if:

  • The usual limitations for oral surgery.
  • Tooth having a vertical fracture of the root on the facial aspect.
  • Tooth having horizontal fracture of the root extending below the level of the bone.
  • Caries on the root segment to be maintained.
  • Mobility of the tooth.
  • Bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

  • de Oliveira GB, Rebello IMC, Montanha Andrade K, Araujo NS, Dos Santos JN, Cury PR. Evaluation of alveolar process resorption after tooth extraction using the socket shield technique without immediate installation of implants: a randomised controlled clinical trial. Br J Oral Maxillofac Surg. 2021 Dec;59(10):1227-1232. doi: 10.1016/j.bjoms.2021.04.001. Epub 2021 Apr 8.

    PMID: 34256958BACKGROUND

Study Officials

  • Soaad T Badawi, Lecturer, Oral Surgery, MU

    Faculty of dentistry, Mansoura university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study followed a parallel-group design. Participants were randomly assigned to two groups: one received the modified socket shield technique and the other received conventional extraction without the socket shield. Both groups were monitored after 6 months to compare alveolar ridge preservation outcomes, with delayed implant placement performed in both groups at 6 months after tooth extraction.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of Oral and maxillofacial Surgery, Faculty of dentistry, Mansoura university.

Study Record Dates

First Submitted

October 22, 2024

First Posted

October 26, 2024

Study Start

February 1, 2023

Primary Completion

July 1, 2024

Study Completion

August 1, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

The individual participant data (IPD) will not be shared due to privacy concerns and the confidential nature of patient data. Additionally, the current study protocol does not include provisions for external data sharing."

Locations