Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques

August 16, 2025 updated by: Guillem Esteve-Pardo, Aula Dental Avanzada

Soft Tissue Volume Changes After Immediate Implants With Two Different Techniques: Randomized Comparative Study.

The aim is to comparatively evaluate the soft tissue volume changes that occur after tooth extraction and immediate dental implant placement using two different surgical techniques.

These techniques are: the Socket-Shield technique and conventional immediate placement.

The null hypothesis is that the Socket-Shield technique better maintains soft tissue volume after partial tooth extraction and immediate implant placement compared to the conventional technique.

From a sample of 20 patients, they will be divided into groups of 10 and will be randomized using the random.org program.

The soft tissue volume will be digitally recorded by intraoral scanning before tooth extraction and 6 months later.

The soft tissue dimensional changes produced will be digitally evaluated and statistically analyzed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

After tooth extraction, the supporting tissues, bone and mucosa will undergo a loss of volume associated with the loss of the cementum-periodontal ligament-bone attachment complex.

This alteration in volume can affect aesthetic results, especially when the tooth involves the anterior area, where the alveolar bone is narrower.

To compensate for the lost volume loss, some authors promote delayed implant placement, which would facilitate soft tissue management after healing.

The conventional immediate implant placement technique proposes the use of bone regeneration biomaterials in the space between the implant wall and the residual vestibular bone. The aim of this technique is to compensate for this bone resorption, thus improving the aesthetic results. In the same sense of compensating for the resorption that will occur, some authors recommend the use of soft tissue grafts in the same operative act of extraction and placement of the immediate implant.

Some years ago, some authors presented the technique of partial extraction of the tooth as an alternative to the conventional technique of immediate implant placement after extraction with the aim of avoiding or minimising this resorption. The technique consists of leaving a piece of tooth (shield) inserted in the vestibular alveolar bone area so that the resorption process is slowed down.

The presence of bone between the dentine wall of the tooth fragment and the implant has been demonstrated in both animal and ex-vivo histological studies.

From a clinical point of view, the Socket-Shield or partial extraction technique has been shown to maintain the vestibular volume in post-extraction implants placed using this technique in both posterior and anterior areas with high aesthetic compromise, maintaining adequate clinical values and patient satisfaction.

On the other hand, a 2015 systematic review, comparing immediate and delayed implantation techniques, reports no significant differences between the two, especially at the soft tissue level, although it mentions a lack of quality in the RCTs analysed.

A 2017 randomized clinical trial compared the conventional immediate implant placement technique with the delayed or early implantation technique, advising against the former when aesthetics were compromised and limiting it to well-selected cases.

In contrast, another more recent randomized clinical trial found no aesthetic, clinical or radiographic differences between the two techniques, and reported similar levels of patient satisfaction.

Likewise, a higher rate of early failure has been found in the immediate implantation technique, mentioning the lack of randomised clinical studies comparing both techniques, especially in terms of soft tissue volume changes.

A recent randomised clinical study comparing the Socket-Shield technique with the conventional implant placement technique found better levels of marginal bone and pink aesthetic assessment in the former, considering it a safe and feasible technique in the anterior sector.

Given the lack of evidence in the literature, there is a palpable need for clinical studies to compare the best technique and/or timing of implant placement after tooth extraction.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03001
        • Clínica Dental Esteve

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients requiring single tooth extraction in lateral or anterior areas of the upper jaw.
  • Teeth that do not present alteration or loss of the vestibular bone table.

Exclusion Criteria:

  • Patients in whom surgical intervention is contraindicated.
  • Teeth with alteration or loss of the vestibular bone table.
  • Teeth with marginal recession >2mm.
  • Early or delayed failure of the implant placed with any of the three techniques.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immediate Implant with SST (SST)
Patients who will receive immediate implant placement using the Socket-Shield Technique.
Procedure: Dental implant placement after tooth extraction
Immediate implant placement after partial or complete tooth extraction.
Other Names:
  • Implant surgery
Active Comparator: Immediate Implant with biomaterial (GAP)
Patients who will receive immediate implant placement using bone biomaterials to fill the gap after complete extraction of the tooth.
Procedure: Dental implant placement after tooth extraction
Immediate implant placement after partial or complete tooth extraction.
Other Names:
  • Implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue volume
Time Frame: 6 months
Soft tissue volume changes after tooth extraction
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgery pain perception by Numerical Rating Scale
Time Frame: Just after surgery
Pain perception by the patient during surgical procedure, being 0 no pain at all, 1-3 mild discomfort, 4-7 moderate pain and 7-10 intense pain.
Just after surgery
Surgery satisfaction of the patient by Numerical Rating Scale
Time Frame: Just after surgery
Patients satisfaction after surgery, being 0 not satisfied at all, and 10 very satisfied
Just after surgery
General satisfaction of the patient by Numerical Rating Scale
Time Frame: 6 months after the beginning of treatment
Patients general satisfaction 6 months after the beginning of treatment, being 0 not satisfied at all, and 10 very satisfied
6 months after the beginning of treatment
Esthetic satisfaction of the patient by Numerical Rating Scale
Time Frame: 3 months after after crown placement
Patients esthetic satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
3 months after after crown placement
Function satisfaction of the patient by Numerical Rating Scale
Time Frame: 3 months after after crown placement
Patients function satisfaction 3 months after crown placement, being 0 not satisfied at all, and 10 very satisfied
3 months after after crown placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aula Dental Avanzada

Investigators

  • Principal Investigator: Guillem Esteve-Pardo, Aula Dental Avanzada

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Estimated)

December 25, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 13, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2025

Last Update Submitted That Met QC Criteria

August 16, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POSTEXO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share with other researches.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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