Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.

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

Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment. Randomized Controlled Trial.

The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A sample of 20 patients in ASAI health status who agree to be involved in the study after giving their consent and who require immediate post-extraction implant treatment in the molar area will be recruited.

The soft tissue status before and 6 months after tooth extraction will be recorded by means of a digital impression taken with the same intraoral scanner.

The patient will be asked to complete a 7-question questionnaire to inform us about his or her perception of the therapeutic process and the final result.

A comparative volume measurement will be made by digitally superimposing the two mesh files obtained before and 6 months after the treatment.

Statistical data will be analysed by an external statistician and conclusions will be drawn about the effect of the technique on soft tissue volume as well as the patient's perception of the procedure and its outcome.

Study Type

Observational

Enrollment (Estimated)

20

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who are assisted in private dental office.

Description

Inclusion Criteria:

  • Patients ASA I
  • Need for molar postextraction immediate implant

Exclusion Criteria:

  • When the cortical bone is affected and the alveolus presents bone deficiencies
  • When dental implant may not be placed due to medical conditions

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Customized Abutment
Customized abutment will be placed after molar immediate implant placement.
Procedure: Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Other Names:
  • Dental implant surgery
Conventional Abutment
Conventional abutment will be placed after molar immediate implant placement.
Procedure: Immediate dental implant placement
Placement of one dental implant immediately after tooth extraction.
Other Names:
  • Dental implant surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Soft tissue dimensional changes
Time Frame: From 0 to 6 months
The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software.
From 0 to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients satisfaction
Time Frame: From 0 to 6 months
Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied).
From 0 to 6 months

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, PhD, Clínica Dental Esteve

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)

September 1, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

August 11, 2022

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 10, 2023

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

Other Study ID Numbers

  • CUSTOM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data sets obtained during the course of this study will be made available from the corresponding author upon reasonable request.

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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